La terapia del dolore in onco-ematologia e le terapie di supporto - Elena Bandieri - Studio ER Congressi

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CONTINUA A LEGGERE
La terapia del dolore in onco-ematologia e le terapie di supporto - Elena Bandieri - Studio ER Congressi
La terapia del dolore in onco-
ematologia e le terapie di supporto.

Elena Bandieri
 USL Modena
La terapia del dolore in onco-ematologia e le terapie di supporto - Elena Bandieri - Studio ER Congressi
Qual’è lo stato dell’arte sulla gestione del
           dolore oncologico?
La terapia del dolore in onco-ematologia e le terapie di supporto - Elena Bandieri - Studio ER Congressi
La terapia del dolore in onco-ematologia e le terapie di supporto - Elena Bandieri - Studio ER Congressi
Is pain in patients with haematological
malignancies under-recognised? The results
from Italian ECAD-O survey
E. Bandieri, D. Sichetti, M. Luppi, C. Ripamonti, G. Tognoni
Leuk Res 2010

    Pain intensity          ST 59.4% moderate severe
                            HT 67.3% moderate-severe
La terapia del dolore in onco-ematologia e le terapie di supporto - Elena Bandieri - Studio ER Congressi
Il setting condiziona l’appropriatezza prescrittiva

                                 “…The patient’s level of
                                 worst pain is subtracted
                                 from the most potent level
                                 of analgesic drug therapies
                                 as prescribed by the
                                 physician…”
La terapia del dolore in onco-ematologia e le terapie di supporto - Elena Bandieri - Studio ER Congressi
Gestione del dolore onco-ematologico
         ancora insoddisfaciente
BISOGNI:
• 1) ottimizzazione della terapia analgesica
  (cronica ad orari fissi e del BTcP);
• 2) un approccio farmacologico migliore non è
  sufficiente per se: il miglioramento della
  terapia del dolore deve avvenire nel contesto di
  un nuovo modello di cure supportivo/palliative
  precoci.
La terapia del dolore in onco-ematologia e le terapie di supporto - Elena Bandieri - Studio ER Congressi
Gestione del dolore da cancro ancora
              insoddisfaciente.
                         :

BISOGNI:
• 1) ottimizzazione della terapia cronica
  ad orari fissi (ATC) (II vs III gradino
  OMS);
• 2) un approccio farmacologico migliore
  non è sufficiente per se: il
  miglioramento della terapia del dolore
  deve avvenire nel contesto di un nuovo
  modello di cure palliative precoci.
La terapia del dolore in onco-ematologia e le terapie di supporto - Elena Bandieri - Studio ER Congressi
Strategia farmacologica:
               i “tre gradini” OMS

  I “tre gradini” consentono di
controllare il dolore oncologico
cronico in circa il 90% dei casi.
Tale approccio, sviluppato nel
1986 da un gruppo di esperti
dell’ Organizzazione Mondiale
della Sanità (OMS), fornisce
specifiche indicazioni per la
scelta della terapia
antidolorifica che non va
somministrata al bisogno ma
a orari fissi.
La terapia del dolore in onco-ematologia e le terapie di supporto - Elena Bandieri - Studio ER Congressi
La strategia a 3 gradini è validata?
                     Perché si cambia gradino?

•   Numerosi studi sono stati condotti per validare
    tale approccio metodologico: sono stati
    osservati oltre 8.000 pazienti in diversi paesi
    del mondo ed in ambienti clinici differenziati
    (ospedale e domicilio).
•   Le varie casistiche riportano un efficace
    controllo del dolore nel 71-100% dei pazienti
    trattati.
•   Tra gli studi eseguiti per validare l’approccio
    OMS quello di Ventafridda et al, (Cancer 1997)
    condotto su 1.229 pazienti seguiti per 2 anni, ha
    evidenziato che il passaggio dal 1° al 2° gradino
    è dovuto in circa la metà dei casi ad effetti
    collaterali e nell’altra metà all’inefficacia
    analgesica, mentre il passaggio dal 2° al 3°
    gradino è soprattutto dovuto all’inefficacia
    analgesica. Efficacia media dei farmaci del
    secondo gradino è di 3 settimane.
La terapia del dolore in onco-ematologia e le terapie di supporto - Elena Bandieri - Studio ER Congressi
Criticità sul secondo gradino
•   Hanno tutti un “effetto tetto”: ciò significa che
    aumentando la dose di un farmaco oltre una certa soglia
    l’efficacia non aumenta (ma possono aumentare gli effetti
    indesiderati).

•   Le specialità a base di codeina disponibili in Italia non
    hanno dosaggi ottimali. Non permettono di raggiungere
    la dose massima efficace di codeina (360 mg/die) senza
    somministrare dosaggi tossici di paracetamolo (la scheda
    tecnica indica 3-4 gr/die).
E le evidenze disponibili?:
•   Non dimostrano una chiara differenza nell’efficacia dei
    farmaci del 1° e del 2° gradino;

•   Non permettono di concludere sui benefici dell’aggiunta
    degli oppioidi minori - in particolare codeina - rispetto al
    solo paracetamolo o al FANS
.

Overall, the limited evidence provided by these
studies shows that oral morphine at low doses can
be used in opioid-naive cancer patients and that in
some patients pain relief might be better than that
achieved with step II drugs…”
QUESITO

E’ possibile abolire il
secondo gradino,
cioè anticipare il terzo
gradino al posto del
secondo gradino
nella terapia
analgesica del dolore
moderato da cancro ?
STUDIO INDEPENDENTE NO SPONSOR
Lo studio ha mostrato un vantaggio altamente significativo nell’
utilizzo della morfina: tra i 118 pazienti che hanno ricevuto la
morfina, piu’ dell’ 88% ha presentato una riduzione del 20% nell’
intensità del dolore, laddove tale riduzione si è potuta
riscontrare nel solo 57% dei 122 pazienti che hanno ricevuto
oppioidi deboli.
In questo studio multicentrico randomizzato, della durata di 28 giorni,
la morfina a basse dosi confrontata con gli oppioidi deboli ha ridotto in
modo statisticamente significativo l’intensità del dolore, già nei primi 7
giorni di terapia. L’efficacia minore e piu’ tardiva degli oppioidi deboli ha
portato i clinici a sostituire piu’ frequentemente gli oppiodi deboli con
quelli maggiori nel trattamento del dolore moderato da cancro nel
periodo di studio.
Gli effetti collaterali piu’ frequentemente associati al
trattamento con oppioidi risultavano paragonabili sia come
intensità che frequenza tanto nei pazienti che ricevevano
morfina a basse dosi quanto nei pazienti che ricevevano
oppioidi minori.
La condizione generale dei pazienti basata sulla
valutazione dei sintomi fisici ed emozionali nel punteggio
globale di tutti i sintomi       misurati dall‘ Edmonton
Symptom Assessment System (ESAS), era migliore nel
gruppo di pazienti trattati con morfina.
Sebbene gli oppioidi deboli
siano efficaci quando usati per
brevi periodi, la morfina a basse
dosi può essere utilmente
anticipata nella terapia del
dolore moderato da cancro, per
la sua maggiore efficacia e
paragonabile profilo di tossicità.
Gestione del dolore da cancro ancora
   insoddisfaciente, sebbene migliorata.
                         :

BISOGNI:
• 1) ottimizzazione della terapia analgesica
• 2) un approccio farmacologico migliore
  non è sufficiente per se: il
  miglioramento della terapia del dolore
  deve avvenire nel contesto di un nuovo
  modello di cure supportive/palliative
  precoci.
Studio multicentrico in 32
ospedali, 1450 pts.con dolore
da cancro: 602 con accesso a
standard care (SOC) e 848 con
accesso a cure palliativa/
supporto precoci (ePSC).

Un’analisi multivariata ha
mostrato che il modello ePSC è
un fattore indipendente in
grado di ridurre il rischio di
dolore severo del 31%
Cure supporto/Cure palliative:
                  contenuto
ESMO definisce Supportive care la cura che ha come obiettivo di
    ottimizzare “comfort, function, and social support” a pazienti e
 famigliari in tutti gli stadi di malattia, inclusa la malattia curabile.

      ESMO definisce Palliative Care la stessa cura rivolta ad una
                                             malattia incurabile.

I termini descrivono programmi clinici comuni
con l’obiettivo primario di controllare i sintomi
fisici (in primis il dolore) psicosociali e
spirituali di pazienti con patologia oncologica e
loro famigliari.
E. BOOK ASCO 2013
L’intervento precoce di cure supporto/
       palliative: quali evidenze?
Early Versus Delayed Early Palliative Oncology Care
                                    VOLUME           33     !   NUMBER             13   !   MAY    1       2015

                                    JOURNAL OF CLINICAL ONCOLOGY
                                                        VOLUME          33     !     NUMBER       13   !    MAY   1    2015
                                                                                                                                  O R I G I N A L                      R E P O R T
mographic and Clinical Characteristics of                                                   Table 1. Baseline Demographic and Clinical Characteristics of
Patient Participants                                                          Patient Participants (continued)
                                                        JOURNAL OF CLINICAL ONCOLOGY                 O R I G                                                       I N A L            R E P O R T
                                 Delayed                                                                                                          Delayed
            Early Group            Group                                                                                           Early Group     Group
             (n ! 104)          (n   ! 103)
                            Marie A. Bakitas, J. Nicholas Dionne-         Early Versus Delayed                            Initiation(nof! Concurrent
                                                                                                                                          104)   (n ! Palliative
                                                                                                                                                      103)

            No.      %
                            Odom, and Andres Azuero, University
                              No.             %           P
                                                          !
                            of Alabama at Birmingham, Birming-            OncologyCharacteristic
                                                                                             Care: Patient Outcomes            No. in%the ENABLE    No.       % III P!
                            ham, AL; Marie A. Bakitas, Jennifer
                                                                          Randomized
                                                Marie A. Bakitas, J. Nicholas Dionne-    Early  Versus        Delayed
                                                                                                Controlled Trial 4           Initiation       of  Concurrent        Palliative
                                                          .68
                            Frost, and Konstantin H. Dragnev,                      6 to 12                                                7.27      4        6.78
              64.03                  64.6
                                                Odom, and Andres Azuero, University
                            Dartmouth-Hitchcock Medical Center;
                                                of Alabama at Birmingham, Birming-
                                                                          Marie A.#
                                                                                         Oncology Care: Patient
                                                                                      12 Tor D. Tosteson, Zhigang Li, Kathleen
                                                                                    Bakitas,
                                                                                                                                 Outcomes
                                                                                                                              42D. Lyons,
                                                                                                                                        76.36
                                                                                                                                                  in Versus
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                                                                                                                                                  48 Zhongze81.36
                                                                                                                                          Jay G. Hull,       Li,
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                                                                                                                                                                Delayed Early
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                                                                          J. Nicholas Dionne-Odom,
                                                                                         packs per day        Controlled
                                                                                                   Jennifer Frost,                TrialMark T. Hegel, Andres Azuero, .06
                                                                                                                   Konstantin H. Dragnev,
                            Kathleen D. Lyons, and                        and Tim
                                                    Mark T. Hegel, Medical Center;
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                                                                                      Ahles
           56     53.85      53         51.46
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                                                Zhongze   .78
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                                                          Dart-                  ! .5Marie A. Bakitas, Tor D. Tosteson, Zhigang
                                                              Norris Cotton Cancer                                          15 Li, Kathleen
                                                                                                                                       27.27      24Jay G. Hull,
                                                                                                                                            D. Lyons,       40.68Zhongze Li,
                            mouth; Zhigang Li and Jay G.
                                                                          See accompanying
                                                         Hull, Tor D. Tosteson,
                                                                                              editorial
                                                                                     J. Nicholas        on pageJennifer
                                                                                                 Dionne-Odom,    1420 Frost, Konstantin H. Dragnev, Mark T. Hegel, Andres Azuero,
                                               Center,
                            Dartmouth College, Hanover,
                                                          .68
                                                       Lebanon;
                                                         NH;
                                                                                    Table   1. Baseline
                                                                                 1 and Tim A. Ahles
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                                                                                                           Demographic       and
                                                                                                                            23     Clinical Characteristics
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                                                                                                                                                            27.12                                                                                             Table 1. Baseline Demographic and Clinical Characterist
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                            Tim A. Ahles, Memorial Sloan-Kettering
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                                                                                                      1.5 See accompanying editorial on page111420 20   S  Participants
                                                                                                                                                              T     R     A      C     T       5              8.47                                                              Patient Participants (continued)
                            Cancer Center, Newmouth;
                                               York, NY.
                                                       Zhigang Li and Jay G. Hull,
tner       69      66.35     66                64.08 Dartmouth College, Hanover,
                            Published online ahead of print at
                                                                                         NH; and 2
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                                                 March 23, 2015.
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                                                                                                            resource useinwere                daysfor(1.57;   95%      CI, 0.37
                                                                                                                                                                             (0.73;to95%             .27),toand      home
                                                                                                                                                                                                                       P ! death          (27
                                                                                                                                         similar        hospital
                                                                                                                                                                                                                 structured weekly
                                                                                                                                                                                                               1.27;            .26), intensive       care
                            CPPB                and Clinical Research
                            from the American Cancer Society                                     "
                                                                                      [54%]Hematologic
                                                                                                       High
                                                                                                    v 28 [47%];
                                                                                                               school
                                                                                                            unit days
                                                                                                                             graduate
                                                                                                                       Pmalignancy
                                                                                                                          !
                                                                                                                                                                 8
                                                                                                                               .60).95% CI, 0.23 to 2.02;5P ! .49), emergency
                                                                                                                           (0.68;
                                                                                                                                                                                 7.69
                                                                                                                                                                                 4.81           3
                                                                                                                                                                                               5room visits    2.91
                                                                                                                                                                                                              4.85 (0.73; 95% CI, 0.45 to 1.19;
                                                                                                                                                                                                                                                    Alcoholic    beverages    in typical
            1       0.96        0                0.0 Scholar Grant No. MRSG 12-113-01-
                                                                                                                                                                                                                                                          week                                    2.56     5.76   1.22
                                                     CPPB in Applied and Clinical ResearchHigh school                   graduate                                61 (1.57; 58.65               50 to 6.7;48.54
                            (K.D.L.).
                                                                                          Disease           P ! .21),
                                                                                                            status       atchemotherapy
                                                                                                                             enrollment         in last 14 days                 95% CI, 0.37                  P ! .27),.24    and home death (27
           23
           13
                   22.12
                   12.5
                             21
                            Presented

                             15
                                               20.39
                                          at the 50thfrom   the American
                                                        Annual
                                                     (K.D.L.).
                                               14.56May
                            of the American Society        of Clinical
                                                                                      Conclusion [54%] v 28 [47%]; P ! .60).
                                                                   MeetingCancer Society
                                                                                      Early-entryCollege
                                                                                                New             graduate patient-reported outcomes
                                                                                                           participants’
                                                                                                          diagnosis                                             35
                                                                                                                                                               48          and 33.65
                                                                                                                                                                                   resource
                                                                                                                                                                               46.15          50 use were
                                                                                                                                                                                             46             48.54
                                                                                                                                                                                                            44.66
                                                                                                                                                                                                                 telephone coaching
                                                                                                                                                                                                                     not statistically CAGE‡                                                      0.84     1.01   0.77
                                                                                      different;         however,
                                                                                                            Conclusion  their   survival   1-year    after  enrollment        was    improved      compared          with    those      who         Caregiver    enrolled                        63       60.58  61
            2       1.92
                            Oncology, Chicago, IL,
                                4
                            2014.                3.88
                                                                30-June    3,
                                                     Presented at the 50th Annual Meeting
                                                     of the American Society of began
                                                                                            Race†
                                                                                                Recurrence
                                                                                      Clinical 3 months
                                                                   Chicago, IL, Mayremains
                                                                                                 White
                                                                                                            Early-entry        participants’ the
                                                                                                                   later. Understanding
                                                                                                            different;     however,
                                                                                                   3, an important research priority.    their
                                                                                                                                                       complex
                                                                                                                                                survival
                                                                                                                                                               29 mechanisms
                                                                                                                                                  patient-reported
                                                                                                                                                              102
                                                                                                                                                            1-year    after
                                                                                                                                                                               27.88 whereby
                                                                                                                                                                           outcomes
                                                                                                                                                                               98.08
                                                                                                                                                                              enrollment
                                                                                                                                                                                             20 resource
                                                                                                                                                                                            and
                                                                                                                                                                                              98
                                                                                                                                                                                              was
                                                                                                                                                                                                      PC 19.42
                                                                                                                                                                                                    improved95.15
                                                                                                                                                                                                                 sessions by an
                                                                                                                                                                                                            mayuse  improve
                                                                                                                                                                                                                     compared
                                                                                                                                                                                                                             .52
                                                                                                                                                                                                                          weresurvival
                                                                                                                                                                                                                                     not statistically
                                                                                                                                                                                                                                      with those who
                                                                                                                                                                                                                                                    Lives in rural area                          62       59.62 60
                            Authors’ disclosuresOncology,
                                                      of potential.33                  30-June  Progression                                                    27              25.96         36             34.95
           37      35.58
                            conflicts of interest are
                             40 online at38.83
                            article
                                                     2014.found in the
                                                www.jco.org.       Author
                                                     Authors’ disclosures             J ClinDo
                                                                                of potential
                                                                                                 Black
                                                                                                   Oncol
                                                                                                            began 3 months later. Understanding 0
                                                                                                        notremains
                                                                                                              know an important
                                                                                                             33:1438-1445.           © 2015  research
                                                                                                                                                                  the complex
                                                                                                                                                                 0 Society 0.0
                                                                                                                                                          priority.
                                                                                                                                                by American
                                                                                                                                                                                 0.0mechanisms  1       whereby
                                                                                                                                                                                 of Clinical1Oncology0.97
                                                                                                                                                                                                                 advanced practice
                                                                                                                                                                                                               0.97PC may improve survival          Diagnosis
                                                                                                                                                                                                                                                       Lung                                      46       44.23 42
                                                                                                 Other                                                         172               1.92 183                      2.91 .71
                                                                                                                                                                                                                 nurse.
                            contributions are found       at theofend    of are found inBrain           metastasis at enrollment                                               16.35                        17.48
           42      40.38     33                32.04 conflicts       interest                the
                                                                                                                                                                                                                                                       GI  tract                                 26       25     24
                            this article.            article online at www.jco.org. AuthorMissing           J Clin Oncol 33:1438-1445. © 2015 by                      American
                                                                                                                                                                 0 as a result,      Society    of
                                                                                                                                                                                 0.0PC is offered
                                                                                                                                                                                                1   Clinical     Oncology
                                                                                                                                                                                                               0.97
           20      19.23     27 trial information:
                                               26.21 contributions are found at the end   Charlson
                                                                                                of           score                                               6.3             1.62          6.21      late,1.86if at all..71
                                                                                                                                                                                                                              2
                                                                                                                                                                                                                                 Similarly,
                            Clinical                       NCT01245621.                                           INTRODUCTION
                                                                                            Religion performance status                                              delaying     PC consultation                            .96                       Breast                                    10        9.62  13
            5       4.81        3
                                                     this article.
                                                 2.91Marie A. Bakitas,                    Karnofsky                                                            80.58           10.87         81.46PCuntil
                                                                                                                                                                                      as a result,
                                                                                                                                                                                                                 patients.54
                                                                                                                                                                                                           is 9.74
                                                                                                                                                                                                               offered late,
                                                                                                                                                                                                                              are hospice2
                                                                                                                                                                                                                                  if at all. Similarly,
                            Corresponding      author:
                                                                                                 CatholicSociety of Clinical
                                                                                      The American
                                                     Clinical trial information: NCT01245621.                                            Oncology provi- 34 eligible32.69
                                                                                                                                     INTRODUCTION                               or admitted   31PC          30.1 until
                                                                                                                                                                                                  to the hospital        for a medical                 Other solid tumor                         10        9.62 10
ealth      72      69.23    DNSc, CRNP, School of Nursing/Depart-
                             70                67.96              .88                     Anticancer treatment at enrollment                                                          delaying        consultation
                                                                                                                                                                     crisis3 prevents patients from receiving all of the
                                                                                                                                                                                                                                  patients are hospice
                                                     Corresponding
                            ment of Medicine, University          of author: Marie    sional     clinical
                                                                                                 Protestant
                                                                                        A. Bakitas,         opinion     recommends        that  “combined
                                                                                                            The American Society of Clinical Oncology           31 provi-29.81        eligible32or admitted 31.07  to the .52hospital                  Genitourinary
                                                                                                                                                                                                                                           for a medical                tract                     7        6.73   9
t month    63      87.5      59 at Birmingham,
                            Alabama            84.29 DNSc,        .47
                                                              CRNP,
                                                            1720    2ndSchool         standard
                                                                         Ave of Nursing/Depart- Chemotherapy
                                                                                                        oncology care and palliative care (PC) 76 potential                    73.08
                                                                                                                                                                                  benefits380that early PC  77.67has to offer.     4-6
                                                                                                 Jewish                                                                               crisis   prevents    patients     from      receiving     all  ofHematologic
                                                                                                                                                                                                                                                        the            malignancy                 5        4.81   5
                                                                                                   be considered early in the course of illness for 201                          0.96           0 PC provides  0.0
                            South, Birmingham, ment          of Medicine, University of
                                                      AL 35294-1210;                                        sional   clinical   opinion   recommends       that “combined
                                                                 at Birmingham, 1720 2nd Radiotherapy       standard oncology care and palliative care (PC)19.23                             20   benefits19.42
                                                                                                                                                                                                             that early1.00
                                                     Alabama1.00
                                                                                      shouldAve                                                                             In contrast,       early                        anticipatory
                                                                                                                                                                                      potential                            PC has to offer.4-6
                            e-mail: mbakitas@uab.edu.
                                                                                                 None with metastatic cancer and/or high 23 guidance
                                                                                      anyInpatient                                                                             22.12          21 management
                                                                                                                                                                                  about symptom             20.39 and thought- Disease status at enrollment
           25      24.04     24                23.3
                                                     South, Birmingham, AL 35294-1210;
                                                                                                 a clinical      trialbeat
                                                                                                            should            enrollment
                                                                                                                          considered     early in the course19  of illness for18.27 In8contrast, 7.77         early PC.04     provides anticipatory
                            ©  2015 by American        Society of Clinical
                                                     e-mail: mbakitas@uab.edu. symptom burden.”1p880 A gap exists between this
                                                                                                 Other      any     patient    with    metastatic    cancer     13
                                                                                                                                                               and/or
                                                                                                                                                                     ful discussions
                                                                                                                                                                          high 12.5       on
                                                                                                                                                                                      guidanceadvanced
                                                                                                                                                                                              15 about     care
                                                                                                                                                                                                            14.56
                                                                                                                                                                                                         symptom   planning
                                                                                                                                                                                                                       managementand goals             New diagnosis
                                                                                                                                                                                                                                             and thought-
                                                                                                                                                                                                                                                                                                 48       46.15 46
           49      47.12
                            Oncology
                             50                48.54                                      Advance directive
                                                                                      recommendation               and currentin medical
                                                                                                                                    practice,
                                                                                                                                       1p880 and there is            of care   that engage     individuals      to consider      their    val- and goals
                                                     © 2015 by American Society
                            0732-183X/15/3313w-1438w/$20.00
                                                                                        of Clinical
                                                                                                 Missing    symptom        burden.”           A  gap  exists     2
                                                                                                                                                               between     this  1.92 ful       4
                                                                                                                                                                                          discussions    on    3.88
                                                                                                                                                                                                             advanced      care    planning            Recurrence                                29       27.88 20
The finding of a 15% improvement in 1-year survival in patients
with advanced cancer of mixed diagnoses receiving early (v 3-
month delayed) PC is consistent with the improved survival noted
in Temel’s study in patients with non–small-cell lung cancer only
(11.6 v 8.9 months).
                                                                                   Early Versus Delayed Early Palliative Oncology Care

                                                                                                              specifically tailored for patients
                                           1.0                                                                ting.4,7 Unlike our prior RCT com
           Overall Survival (proportion)                                                   Early
                                                                                           Delayed
                                                                                                              care, comparison group patient
                                           0.8                                                                3-month delay.15,16 This design
                                                                                                              with usual care at 3 months. W
                                           0.6                                                       63%      patient-reported outcomes; how
                                                                                                              tage was noted in the early-entry
                                                                                                     48%
                                           0.4                                                                      Our finding of a 15% impro
                                                                                                              with advanced cancer of mixed d
                                           0.2
                                                                                                              delayed) PC is consistent with th
                                                                                                              et al6 in their early PC study in
                                                                                                              cancer only (11.6 v 8.9 months;
                                            0           3             6              9           12           suggest that concurrent PC prov
                                                              Time (months)                                   survival benefit by a mechanism
          No. at risk                                                                                         findings, together with improved
          Early       104                               98            83             62           48
          Delayed     103                               89            73             55           39
                                                                                                              for the recommendation of early
                                                                                                              metastatic disease and/or high sy
                                    Fig 2. Kaplan-Meier estimates of 1-year survival by treatment group.            Unlike that by Temel et al6
                                                                                                              study did not demonstrate stat
                                                                                                              QOL or mood related to early PC
L’intervento precoce di supporto/cure
                palliative: quali OBIETTIVI?

Miglioramento:
1. Controllo dei sintomi (dolore), della QoL
2. Dati suggestivi, seppur iniziali, della sopravvivenza
3. Depressione nei care givers
4. Ridefinizione degli obiettivi di cura (Comunicazione)
Riduzione:
5. Cure inappropriate
L’intervento precoce di supporto/cure
               palliative: quali OBIETTIVI?

Miglioramento:
1. Controllo dei sintomi, della QoL
2. Dati suggestivi, seppur iniziali, della sopravvivenza
3. Depressione nei care givers
4. Ridefinizione degli obiettivi di cura (Comunicazione)
Riduzione:
5. Cure inappropriate
VOLUME       33     !    NUMBER   13   !   MAY   1   2015

              JOURNAL OF CLINICAL ONCOLOGY                                                O R I G I N A L              R E P O R T

                                           Benefits of Early Versus Delayed Palliative Care to Informal
                                           Family Caregivers of Patients With Advanced Cancer:
                                           Outcomes From the ENABLE III Randomized
                                           Controlled Trial
                                           J. Nicholas Dionne-Odom, Andres Azuero, Kathleen D. Lyons, Jay G. Hull, Tor Tosteson, Zhigang Li,
                                           Zhongze Li, Jennifer Frost, Konstantin H. Dragnev, Imatullah Akyar, Mark T. Hegel, and Marie A. Bakitas
                                           See accompanying editorial on page 1420

Early-group: Care Givers had lower depression (6%
  J. Nicholas Dionne-Odom, Andres
  Azuero, Imatullah Akyar, and Marie A.                                         A   B    S    T   R    A   C    T
  Bakitas, University of Alabama at
  Birmingham, Birmingham, AL; Kathleen     Purpose

decrease) and stress burden in the terminal
  D. Lyons, Jay G. Hull, Zhigang Li, and
  Mark T. Hegel, Dartmouth College; Tor
  Tosteson and Zhongze Li, Norris Cotton
                                           To determine the effect of early versus delayed initiation of a palliative care intervention for family
                                           caregivers (CGs) of patients with advanced cancer.

analysis.                                  Patients and Methods
  Cancer Center, Hanover; and Jennifer
  Frost and Konstantin H. Dragnev,         Between October 2010 and March 2013, CGs of patients with advanced cancer were randomly
  Dartmouth-Hitchcock Medical Center,
                                           assigned to receive three structured weekly telephone coaching sessions, monthly follow-up, and
  Lebanon, NH.
                                           a bereavement call either early after enrollment or 3 months later. CGs of patients with advanced
  Published online ahead of print at       cancer were recruited from a National Cancer Institute cancer center, a Veterans Administration
  www.jco.org on March 23, 2015.
                                           Medical Center, and two community outreach clinics. Outcomes were quality of life (QOL),

Palliative care for Care Givers should be initiated as
  Supported by Grant No.
  R01NR011871-01 from the National
  Institute for Nursing Research; by a
                                           depression, and burden (objective, stress, and demand).

                                           Results

early as possible to maximize benefits.
  postdoctoral fellowship supported by
                                           A total of 122 CGs (early, n ! 61; delayed, n ! 61) of 207 patients participated; average age was
  University of Alabama at Birmingham
  Cancer Prevention and Control Training
                                           60 years, and most were female (78.7%) and white (92.6%). Between-group differences in
  Program Grant No. 5R25CA047888           depression scores from enrollment to 3 months (before delayed group started intervention)
  (J.N.D.-O.); an NIH/NINR Small           favored the early group (mean difference, "3.4; SE, 1.5; d ! ".32; P ! .02). There were no
  Research Grant 1R03NR014915-01           differences in QOL (mean difference, "2; SE, 2.3; d ! ".13; P ! .39) or burden (objective: mean
  (Zhigang Li) and by Mentored Research    difference, 0.3; SE, .7; d ! .09; P ! .64; stress: mean difference, ".5; SE, .5; d ! ".2; P ! .29;
  Scholar Grant No. MRSG 12-113-01–
                                           demand: mean difference, 0; SE, .7; d ! ".01; P ! .97). In decedents’ CGs, a terminal decline
  CPPB in Applied and Clinical Research
  from the American Cancer Society
                                           analysis indicated between-group differences favoring the early group for depression (mean
  (K.D.L.).                                difference, "3.8; SE, 1.5; d ! ".39; P ! .02) and stress burden (mean difference, "1.1; SE, .4;
                                           d ! ".44; P ! .01) but not for QOL (mean difference, "4.9; SE, 2.6; d ! ".3; P ! .07), objective
  Presented at the 50th Annual Meeting
  of the American Society of Clinical
                                           burden (mean difference, ".6; SE, .6; d ! ".18; P ! .27), or demand burden (mean difference,
L’intervento precoce di supporto/cure
                palliative: quali OBIETTIVI?

Miglioramento:
1. Controllo dei sintomi, della QoL
2. Dati suggestivi, seppur iniziali, della sopravvivenza
3. Depressione nei care givers
4. Ridefinizione degli obiettivi di cura (Comunicazione)
Riduzione:
5. Cure inappropriate
69% of pa)ents
with lung cancer
and 81% of those
with colorectal
cancer did not
report
understanding that
chemotherapy was
not at all likely to
cure their cancer.
JOURNAL OF PALLIATIVE MEDICINE
Volume 16, Number 8, 2013
ª Mary Ann Liebert, Inc.
DOI: 10.1089/jpm.2012.0547

     The Cultivation of Prognostic Awareness Through the
  Provision of Early Palliative Care in the Ambulatory Setting:
                    A Communication Guide

        Vicki A. Jackson, MD, MPH,1 Juliet Jacobsen, MD,1,2 Joseph A. Greer, PhD,3 William F. Pirl, MD,3
                              Jennifer S. Temel, MD,3 and Anthony L. Back, MD 4

               SPIKES AND NURSE COMMUNICATION ABILITIES
Abstract
Early, integrated palliative care delivered in the ambulatory setting has been associated with improved quality
of life, lower rates of depression, and even prolonged survival. We outline an expert practice that provides a
step-wiseVapproach
            O L U M E 3 2to! cultivating
                              N U M B E R 3 prognostic
                                            1 ! NOVEMB awareness
                                                        E R 1 2 0 1 4in patients cared for by a palliative care clinician early in

the course of the patient’s disease. This approach can be used by both novice and more experienced palliative
           JOURNAL OF CLINICAL ONCOLOGY
care clinicians.                                                               COMMENTS AND CONTROVERSIES

Introduction                                                                    Over the course of receiving care from a skilled palliative
                                                                             care clinician, we have found that many of these patients seem

E   arly, integrated palliative care delivered in the to develop an increased capacity to tolerate discussions about
    ambulatory setting includes consultation and manage- prognosis and accept what this information means to them
     Current State of the Art and Science of Patient-
ment throughout the entirety of the illness for patients with personally. Many of these patients develop the ability to hear,
advanced cancer. This approach has been associated with process, and draw on prognostic information to make medical
     Clinician Communication in Progressive Disease:
improved quality of life, lower rates of depression, and, even, decisions that match their own values—and are grateful to the
prolonged survival.1,2 Many patients with cancer hold an in- clinician who worked with them to reach that point. In sum-

     Patients’ Need to Know and Need to Feel Known
accurate view of the goals of treatment and their prognosis.3,4 mary, we observe patients gradually develop prognostic
These patients have a low ‘‘prognostic awareness.’’ We define awareness through an incremental cognitive and emotional
prognostic awareness as a patient’s capacity to understand his process that can be cultivated over time through interaction
or herLiesbeth  M. and
        prognosis   van the
                         Vliet, King’s
                             likely       College
                                     illness       London,
                                              trajectory.     Cicely Saunders
                                                           Improving    a withInstitute,
                                                                                   a skilledLondon,     United Kingdom
                                                                                               clinician.
     Andrew    S.  Epstein,  Memorial     Sloan-Kettering
patient’s prognostic awareness is an important component of   Cancer  Center,   New   York,   NY
                                                                                We outline here an expert practice that provides a step-
early palliative care because a more accurate understanding of wise approach to cultivating prognostic awareness in pa-
prognosisEffective
            is associated    with earlier
                    communication      rests atenrollment    in hospice
                                               the core of medicine,         tients ficulty
                                                                     especially      cared21—forofby   a palliative
                                                                                                   linking           care clinician
                                                                                                            and responding  to patients’early in the
                                                                                                                                         cognitive and emo-
and lower
     when    rates
            patientsof resuscitation
                     are  confronted     for
                                        with  patients  with
                                               progressive     incurable
                                                            disease and      course
                                                                         death.       of
                                                                                    tionalthe  patient’s
                                                                                            needs          disease.
                                                                                                  simultaneously.   We   illustrate  our   approach
        5,6
cancer.     Palliative can
     Communication      caremitigate
                               clinicians    can facilitate
                                      the distress             enhanced
                                                    of receiving bad news andwith a caseTothat    unfolds
                                                                                              achieve  this, over months.
                                                                                                             we propose thatThis approach can
                                                                                                                             communication         beshould
                                                                                                                                                skills
prognostic awareness in patients with cancer through the use used by both novice and more experienced palliative care
     influence patients’ psychological functioning     and adaptation to a new      be taught within a framework that entails approaches for both
of advanced communication
               1-3                techniques.1                               clinicians. It requires the clinician to assess the patient’s level
Potenza, Galli, Bandieri, Luppi et al.
Journal of Pain and Symptom Management 2015
L’intervento precoce di supporto/cure
                palliative: quali OBIETTIVI?

Miglioramento:
1. Controllo dei sintomi, della QoL
2. Dati suggestivi, seppur iniziali, della sopravvivenza
3. Depressione nei care givers
4. Ridefinizione degli obiettivi di cura (Comunicazione)
5. Cure inappropriate nel fine vita
OLUME      Early introduction of supportive/palliative care also
                33     !     NUMBER       13        !     MAY                1   2015

JOURNAL OF Cled  to less aggressive end-of-life
             LINICAL ONCOLOGY
                                                care, reduced
                                       O R I G I N A L R E P O R                                                                                                       T
            chemotherapy in the last 14 days (17.5%).
                                          VOLUME           33     !    NUMBER        13   !   MAY   1   2015

                                          JOURNAL                OF       CLINICAL ONCOLOGY                              O R I G I N A L          R E P O R T

Bakitas, J. Nicholas Dionne-     Early Versus Delayed Initiation of Concurrent Palliative
d Andres Azuero, University
a at Birmingham, Birming-        Oncology Care:  Patient
                                              Early         Outcomes
                                                    Versus Delayed          inofthe
                                                                   Initiation
                                  Marie A. Bakitas, J. Nicholas Dionne-
                                                                                    ENABLE
                                                                                Concurrent        III
                                                                                           Palliative
                                              Oncology Care: Patient Outcomes in the ENABLE III
                                  Odom, and Andres Azuero, University
Marie A. Bakitas, Jennifer
Konstantin H. Dragnev,           Randomized Controlled       Trial Trial
                                  of Alabama at Birmingham, Birming-

                                              Randomized Controlled
                                  ham, AL; Marie A. Bakitas, Jennifer
                                  Frost, and Konstantin H. Dragnev,

h-Hitchcock Medical Center;       Dartmouth-Hitchcock Medical Center;
                                                          Marie A. Bakitas, Tor D. Tosteson, Zhigang Li, Kathleen D. Lyons, Jay G. Hull, Zhongze Li,
 i, Norris Cotton Cancer
                                 Marie A. Bakitas, Tor D. Tosteson,
                                  Zhongze Li, Norris Cotton Cancer
                                                                        Zhigang Li,
                                                          J. Nicholas Dionne-Odom,
                                  Center, Lebanon; Tor D. Tosteson,
                                                                                         Kathleen
                                                                                    Jennifer          D. Lyons,
                                                                                             Frost, Konstantin       Jay G.
                                                                                                               H. Dragnev,    Hull,
                                                                                                                           Mark       Zhongze
                                                                                                                                 T. Hegel,          Li,
                                                                                                                                           Andres Azuero,

 banon; Tor D. Tosteson,         J. Nicholas Dionne-Odom, Jennifer Frost, Konstantin H. Dragnev, Mark T. Hegel, Andres Azuero,
                                                          and Tim A. Ahles
                                  Kathleen D. Lyons, and Mark T. Hegel,
                                  Geisel School of Medicine at Dart-
                                                          See accompanying editorial on page 1420
D. Lyons, and Mark T. Hegel,     and Tim A. Ahles
                                  mouth; Zhigang Li and Jay G. Hull,
                                  Dartmouth College, Hanover, NH; and
hool of Medicine at Dart-         Tim A. Ahles, Memorial Sloan-Kettering                                        A   B   S   T   R   A   C   T

 igang Li and Jay G. Hull,      Chemotherapy use in the last 14 days averaged 7%
                                 See accompanying editorial
                                                    Purpose
                                                            on page 1420
                                  Cancer Center, New York, NY.

                                  Published online ahead of print at
                                                                                 Randomized controlled trials have supported integrated oncology and palliative care (PC);
h College, Hanover, NH; and       www.jco.org on March 23, 2015.
                                                                                 however, optimal timing has not been evaluated. We investigated the effect of early versus
 es, Memorial Sloan-Kettering
                                  Supported by Grant No.
                                  R01NR011871-01 from the National Insti-
                                                                                                A
                                                                                 delayed PC on quality Bof lifeS(QOL),T symptom
                                                                                                                           R    Aimpact,
                                                                                                                                     C mood,
                                                                                                                                         T 1-year survival, and resource use.
 nter, New York, NY.              tute for Nursing Research; by a Cancer         Patients and Methods
                                  and Leukemia Group B Foundation Clini-         Between October 2010 and March 2013, 207 patients with advanced cancer at a National
 online ahead of print at
                                 Purpose
                                  cal Scholar Award; by the Foundation for
                                                                                 Cancer Institute cancer center, a Veterans Affairs Medical Center, and community outreach
                                 Randomized controlled trials have supported integrated oncology and palliative care (PC);
                                  Informed Medical Decision-Making; by
                                  Grants No. P30CA023108, UL1
                                                                                 clinics were randomly assigned to receive an in-person PC consultation, structured PC
org on March 23, 2015.                                                           telehealth nurse coaching sessions (once per week for six sessions), and monthly follow-up
                                 however, optimal timing has not been evaluated. We investigated the effect of early versus
                                  TR001086, and R03NR014915; an
                                  NIH/NINR Small Research Grant                  either early after enrollment or 3 months later. Outcomes were QOL, symptom impact, mood,
 by Grant No.                     1R03NR014915-01 (Zhigang Li); by Norris        1-year survival, and resource use (hospital/intensive care unit days, emergency room visits,
FORMAZIONE: ruolo          centrale
The University of Michigan reduced
chemotherapy use from 50% to about 20% in
the pa)ent’s last 2 weeks of life by simply
ini)a)ng of educa)on in pallia)ve care

               Trends in chemotherapy administered in the last
               2 weeks of life for all studied pa>ents.

                             Blayney et al., J Clin Oncol 2009
of print at
    JOURNAL  OF
                                          The
                                          C    guideline update reflects
                                           LINICAL ONCOLOGY
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                                          quasiexperimental trial, and five secondary analyses from RCTs in the 2012 PCO on p
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mmendations,
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view and analyses                     early  in the disease
                                          Guideline            Updatecourse, concurrent
                                                                   American            Society of Clinical  with activeOncology    treatment.
                                                                                                                                           Clinical Referral
                                                                                                                                                         Practice of patients to interdis
eR.for  each  City of Hope Medical palliative       careJennifer
                                                             teams       is optimal,    Temin, andErin R.services
                                                                                                           Alesi, Tracy A.may         complement               existing
                                                                                                                                                                     I. Firn, programs. Provid
er,
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 ional   information,
    Duarte,  CA; Jennifer S. Temel and
                                          Betty R. Ferrell,        Guideline
                                                                   S. Temel,   SarahUpdate                                  Balboni,    Ethan M. Basch, Janice
                                          Judith A. Paice, Jeffrey M. Peppercorn, Tanyanika Phillips, Ellen L. Stovall,† Camilla Zimmermann, and
ey M. Peppercorn, Massachusetts refer family and friend            Betty R.caregivers             of Sarah
                                                                           Ferrell, Jennifer S. Temel,
                                             Betty R. Ferrell, City of Hope Medical                    patients
                                                                                                           Temin, Erinwith      early
                                                                                                                      R. Alesi, Tracy     or advanced
                                                                                                                                      A. Balboni,                  cancer
                                                                                                                                                  Ethan M. Basch, Janice I. Firn, to palliative care s
                                          Thomas J. Smith
 ment with
 ral Hospital; Tracy A. Balboni,      Center, Duarte, CA; Jennifer S. Temel and           Judith A. Paice, Jeffrey M. Peppercorn, Tanyanika Phillips, Ellen L. Stovall,† Camilla Zimmermann, and
 Farber Cancer Institute, Boston, MA; Jeffrey M. Peppercorn, Massachusetts                Thomas J. Smith
es,  a Methodology                    General Hospital; Tracy A. Balboni,

                                         JSarahClin           Oncol 34. © 2016 by American Society of Clinical Oncology
  Temin, American Society of Clinical
                                             Dana-Farber Cancer Institute, Boston, MA;                     A     B    S     T     R     A    C     T
  clinical tools and
 logy, Alexandria; Erin R. Alesi,
                                                  Temin, American Society of Clinical
 ia Commonwealth University Health         Oncology, Alexandria; Erin R. Alesi,
                                                                                                                                     A     B    S   T   R   A  C    T
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 m, Richmond, VA; Ethan M. Basch,                   Purpose
                                           Virginia Commonwealth University Health
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                                                     Richmond,    VA; Ethanevidence-based
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available      at  www.                                                                        To provide   evidence-based      recommendations
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                                                                                                                                                        oncology clinicians,  patients, family  and friend          3
                                                    caregivers,
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                                                                                      Hill,        care specialists         to update                            from
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                                                   Hill, NC; Janice I. Firn, University of     caregivers,  and  palliative  care specialists to update the 2012 American    Society
                                                                                            clinical opinion (PCO) on the integration of palliative care into standard oncology      of Clinical Oncology
h A. Paice, Northwestern University,       Michigan   Health
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                                                              System,    Ann
                                                              for all patients
                                                                               Arbor, MI;
                                                                                             diagnosed       with cancer.                                        Bottom Line Box). Patients with advance
                                                                                               (ASCO) provisional clinical opinion (PCO) on the integration of palliative care into standard oncology
eswiki.
                                           Key Recommendation
                                           Judith A. Paice, Northwestern      University,
ston, IL; Tanyanika Phillips,                                                                  care for all patients diagnosed with cancer.
                                             Evanston, IL; Tanyanika Phillips,
 STUS St Frances Cabrini Hospital,                  Methods
                                             CHRISTUS St Frances Cabrini Hospital,        Methods                                                          are defined as those with distant metastases,
 potential conflicts
 ndria, LA; Ellen L. Stovall, National       ASCO convened an Expert                  Panel ofanmembers
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prehensive Cancer Center, Johns              the National Cancer Institute               Physicians
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 ins University, Baltimore, MD; and Society   University,of    Clinical          Oncologyseeking(ASCO)              guideline                  prognosis           of   6andtoandmeta-
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                                     Comprehensive Cancer Center, Johns
ontributions       are               Hopkinsupdated           systematic        review
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slaarticle.
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                                             Zimmermann, Princess Margaret                  well as secondary analyses
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                                             Published online ahead of print at
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-mail:
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                                             www.jco.org on October 31, 2016.
                                           carequasiexperimental
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                                                                                          quasiexperimental trial, and five secondary analyses from RCTs in the 2012 PCO on providing
 .jco.org on October 31, 2016.

 al Practice Guideline Committee           the    disease          course,
                                             Clinical Practice Guideline Committee
                                                palliative care services
                                             approved: August 15, 2016.
                                                                                  concurrent
                                                                         and five secondary
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                                                                                            analyses
                                                                                                      with
                                                                                     with cancer and/or
                                           the content into a guideline. The 2012 PCO was
                                                                                                               active
                                                                                                        their caregivers,   treatment.
                                                                                                                    the 2012 PCO
                                                                                                                          including
                                                                                                                                    on providing
                                                                                          palliative care services to patients with cancer and/or their caregivers, including family care-
                                                                                                                                    family care-
                                                                                                                   updated evidence on early palliative care, i
                                                                                          givers, were found to inform the update.
 ved: August 15, 2016.
American Society                                     givers, were found to
                                             Editor’s note: This American Society of          inform the update.
                                                                                           Recommendations
r’s note: This American Society of
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                                           based on a review of the 2010 study by Temel
                                             Clinical Oncology clinical practice
                                                     Recommendations
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                                                                                           Inpatients and outpatients with advanced cancer should receive dedicated palliative care services,
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                                                                             with teams is optimal, and services may complement existing programs. Providers may
o.org.
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                                             asco.org/palliative-care-guideline and
                                             www.asco.org/guidelineswiki.
                                                                                      weeks
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                                               J Clin Oncol 34. © 2016 by American Society of Clinical Oncology
                                             at www.cancer.net, is available at www.
                                                                                                             addedfrom     the National Consensus Project (provided in
                                                                                                                               professionals and other clinicians can
                                                                                                                     Bottom Line Box). Patients with advanced cancer
                                                                                                                                                       3
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                                                                                                        from the National     Consensus
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                                                               INTRODUCTION  As
                                       Authors’ disclosures of potential conflicts  in   the   2012    PCO,        this
                                                                                                        Bottom Line
                                                                    The purpose of this version of the American
                                       of interest are found in the article online at
                                                                                                                     are definedpalliative
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ors’ disclosures of potential conflicts found at the end of this article.                   of palliative
                                                                            of Clinical Oncology (ASCO) are
                                                                                                        guidelinecare
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“Chiunque soffre cerca di
comunicare la sua
sofferenza; e solo così
facendo, la diminuisce
veramente.
Coloro che soffrono non
hanno, in fondo, bisogno
d'altro, che di uomini capaci di
prestar loro attenzione.
Ma la capacità di dare
attenzione a chi soffre è cosa
rarissima; quasi un miracolo.”

      L'ombra e la grazia- 1943
           Simone Weil
:
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