La terapia del dolore in onco-ematologia e le terapie di supporto - Elena Bandieri - Studio ER Congressi
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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
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…”
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.
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.
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 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.
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 Early the ENABLE 48 Zhongze81.36 Jay G. Hull, Li, III Palliative Oncology Care Delayed Early Zhongze Li, Norris Cotton Cancer 10.28 9.59 ham, AL; Center, Lebanon; TorFrost, Marie A. Bakitas, Jennifer D. Tosteson, No.A.of and Konstantin H. Dragnev, Randomized 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; Dartmouth-Hitchcock Ahles 56 53.85 53 51.46 Geisel School of Medicine Zhongze .78 at Li, 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 and and Mark T. Hegel, Demographic and 23 Clinical Characteristics 41.82 16 of 27.12 Table 1. Baseline Demographic and Clinical Characterist Kathleen D. Lyons, 7 6.73 5 4.85 Tim A. Ahles, Memorial Sloan-Kettering Geisel School of Medicine at Dart- A Patient B 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 Purpose 2 3.64 6 Delayed 10.17 Dela 15 14.42 Within 30-60 days 21 www.jco.org on20.39 March 23, 2015. Cancer Center, New York, NY. Randomized controlled trials have supported Tim A. Ahles, Memorial Sloan-Kettering 2.5 A B 0 integrated Early S T oncology Group however, optimal timing has not been evaluated. We investigated the effect of early versus (n ! 0.0 104) R A C and 3 (n ! T palliative care (PC); Group 103) 5.08 3-month delay Early Group (n ! 104) (n Gro ! 13 12.5 11 Supported by 10.68 Grant No. Published online ahead of print delayed at Purpose 3PC on quality of life (QOL), symptom impact, 3 mood,5.451-year4survival, 6.78 and resource use. R01NR011871-01 from the National Insti- Randomized controlled trials have supported integrated oncology and palliative care (PC); tute for Nursing Research; by a.05 Used and other tobacco 13No.evaluated. 12.5 % We13 12.62 %the 1.00 www.jco.org on March 23, 2015. Cancer Patients Characteristic however, Methods optimal timing has not been No. investigated P! of early versus effect Characteristic No. % No. and Leukemia Group Supported by Grant Clini- No. Between October 2010 8 7.69 3 2.91 B Foundation Alcoholic delayed beverages PC onandin March quality typical 2013, of life (QOL), 207symptom patientsimpact,with advanced mood, 1-year cancer at a and survival, National resource use. cal Scholar Award; byR01NR011871-01 from the National Insti- the Foundation for CancerAge,Institute Research; by a Cancer week years cancer center, a Veterans Affairs 2.56 Medical 5.76Center, 1.22and community 2.84 .04 .68outreach 6 to 12 4 7.27 4 61 58.65 50 Medical48.54 Informed tute for Nursingby Decision-Making; clinics werePatients randomly and Methods assigned toandreceive an2013,in-person PC consultation, structured PCa National Grants No. P30CA023108, and Leukemia UL1 Group B Foundation CAGE‡ Mean Clini- Between October 2010 March 0.84 64.03 2071.01patients with64.6advanced 0.77 and 0.6 cancer .82 at # 12 42 76.36 48 35 33.65 50 TR001086, and 48.54 cal Scholar an R03NR014915; telehealth Award; by the Foundation for nurse Cancer coaching Institutesessions (once per cancer center, week forAffairs a Veterans six sessions), Medical 9.59 Center, monthly follow-up outreach and community either bySDearly after enrollment or 3 months later. 10.28 Outcomes were QOL, symptom impact, No. of packs per day NIH/NINR Small Research Informed Medical Decision-Making; Grant .52 Caregiverclinics enrolled were randomly assigned 63 to receive 60.58 an 61 in-person PC 59.22 consultation,.89 mood, structured PC Grants No.Li); P30CA023108, UL1 1R03NR014915-01 (Zhigang by Norris 1-yearMale survival, sex and resource telehealth nurse use (hospital/intensive coaching sessions 56 (once care 53.85 per unit for week days, 53 six emergency 51.46 sessions), room and .78 visits, follow-up monthly ! .5 15 27.27 24 102 98.08 98 Cancer Center 95.15 TR001086, and by R03NR014915; an Lives in rural chemotherapy in area last 62 59.62 60 58.25 .78 early14after days, and death location). Cotton pilot funding; NIH/NINR Small Research Grant Marital status either enrollment or 3 months later. Outcomes were QOL, symptom .68 impact, mood, 1 23 41.82 16 1R03NR014915-01 (Zhigang Li); Diagnosis .97 the Dartmouth-Hitchcock Section of Palli- 0 0.0 1 Medicine; by0.97 by Norris Results 1-year survival, and resource use (hospital/intensive care unit days, emergency room visits, Initial, standardized ative a National Palliative Cotton Cancer Center pilot funding; by Overall Never Lung married chemotherapy patient-reported in last were outcomes 14 days, and46 7 death location). not statistically 6.73 44.23 after significant 5 42 enrollment 4.85 40.78(QOL, P ! .34; 1.5 11 20 5 2 1.92 3 2.91 Care Research Center Junior Career the Dartmouth-Hitchcock Section of Palli- ative Medicine; by a Nationalsymptom Development Award (M.A.B.); by Grant Married GI impact, tract or Pliving Results ! .09; with partner mood, P ! .33) or before 69 death 26 66.35 25 (QOL, P24 66 64.08 impact, P ! ! .73; symptom 23.3 2 2 3.64 6 0 0.0 No.15R25CA047888 0.97 consultation by a PC Palliative from the University Care Research Center Junior.30; Careermood, Divorced POverall ! .82). or Kaplan-Meier 1-year patient-reported separated outcomes survival were 15 rates were 63%significant not statistically 14.42 in the early 21 after 20.39group and 48% enrollment (QOL,in P ! .34; 2.5 0 0.0 3 of Alabama at Birmingham Cancer Breast symptom P10 9.62 13early to12.62 Prevention and Control Training.96 Development Award (M.A.B.); Program the delayed by Grant group (difference, impact, P 15%;! .09; Pmood,! .038). Relative ! .33) ratesdeath or before of (QOL, Pdelayed decedents’ ! .73; symptom impact, P ! Widowed 13 12.5 11 10.68 3 3 5.45 4 34 32.69 31 (J.N.D.-O.); and 30.1 No. 5R25CA047888 from theresource by Mentored Research of Alabama at Birmingham Cancer Scholar Grant No. MRSG 12-113-01- University unit Other days Education usesolid (0.68; were .30; the Genitourinary 95% similar tumor mood, delayedCI, P !for 0.23 group to tract last 14 hospital .82). 2.02; P days (0.73; Kaplan-Meier (difference, ! .49), 15%; 10 95% 1-year emergency P 7 days ! CI,9.62 survival 0.41 room .038). rates to101.27;63% were visits Relative 6.736.7; CI, P ! 9.71 (0.73; rates in 95% of clinician and six .26), theintensive CI, early early group 0.45 to .05 to delayed care 1.19; and 48% in Used other tobacco decedents’ 13 12.5 13 P9 !0.41 8.74 Prevention and Control Training Program 31 29.81 32 in Applied31.07 (J.N.D.-O.); and by MentoredPResearch! .21), chemotherapy 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 changesSinPevidence A S C O since E C I A L the previous guideline. Nine RC A R T I C L E er 31, 2016. quasiexperimental trial, and five secondary analyses from RCTs in the 2012 PCO on p ne Committee palliative care JOURNAL services OF CLINICAL Oto patients with NCOLOGY A S Ccancer O S P Eand/or C I A L their caregivers, A R T I C L E including fam 016. givers, were found to inform the update. rican Society of al practice Recommendations Integration of Palliative Care Into Standard Oncology Care: Inpatients American and outpatients Society of with Clinical advanced Oncology cancer should receive dedicated palliative care s mmendations, Integration of Palliative Care IntoClinical Standard Practice Oncology Care: 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, Ferrell, 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 atient information m, Richmond, VA; Ethan M. Basch, Purpose Virginia Commonwealth University Health ersity of North Carolina at Chapel Hill, System,To provide Richmond, VA; Ethanevidence-based M. Basch, Purpose recommendations to oncology clinicians, patients, family and friend available at www. To provide evidence-based recommendations the 2012toAmerican oncology clinicians, patients, family and friend 3 caregivers, el Hill, NC; Janice I. Firn, University of University of North Carolina atandChapel palliative Hill, care specialists to update from Society the National of Clinical Consensus Oncology Project (pro guideline and Ann Arbor, MI; gan Health System, Chapel (ASCO) provisionalINTRODUCTION 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 care 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 ASCO convened Alexandria, LA; Ellen L. Stovall, National ofofthe Expert Panel ASCO members ofAd the Hoc ASCOPalliative Care Expert Ad Hoc Palliative Panel Care Expert toto Panel at KimmelThe purpose of this version of2012the was based on a review ofdisease, PCO American cancertrialthat is life limiting, and ion for Cancer Survivorship, Silver he articleJ. online develop an update. The 2012 Coalition for Cancer Survivorship, Silver develop PCO was an update. The based on a review of a randomized controlled trial a randomized controlled (RCT) by (RCT) by g; Thomas Smith, Sidney Spring; Thomas J. Smith, Sidney Kimmel prehensive Cancer Center, Johns the National Cancer Institute Physicians the National DataPhysicians Cancer Institute Query and Dataadditional trials. The Query and additional panel trials. conducted The panel conducted anan ins University, Baltimore, MD; and Society University,of Clinical Oncologyseeking(ASCO) guideline prognosis of 6andtoandmeta- 24 months. This update Comprehensive Cancer Center, Johns ontributions are Hopkinsupdated systematic review updated systematic randomized review seeking clinical trials, randomized systematic clinical trials, reviews, systematic reviews, meta- Patients with advanced cancer, clinical should nine RCTs,receive Baltimore, MD; and slaarticle. Zimmermann, Princess Margaret Camilla analyses, analyses, as analyses as well as secondary Zimmermann, Princess Margaret well as secondary analyses of RCTs in theof 2012 RCTs inPCO, the 2012 PCO, published published from from MarchMarch 20102010 toto er Centre, Toronto, Ontario, Canada. is toJanuary update the 2012 ASCO Cancer Centre, Toronto, Ontario, Canada. 2016. provisional January 2016. as well as one quasiexperimen Mill Rd, Suite 800, dedicated supportive/palliative 1 care services, early in †Deceased. eased. opinion Results (PCO) on the integration of palliative Published online ahead of print at Results and five secondary publications from pr The guideline update reflects changes in evidence since the previous guideline. Nine RCTs, one -mail: shed guidelines@ online ahead of print at The guideline update reflects changes in evidence since the previous guideline. Nine RCTs, one www.jco.org on October 31, 2016. carequasiexperimental into standardtrial, oncology care and from RCTs inreviewed transition RCTs. It reviews and analyzes 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 to patients 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 18 al Mill Rd, Oncology clinical practice based on a review of the 2010 study by Temel Clinical Oncology clinical practice Recommendations guideline provides recommendations, evidence on patients in both inpatient a Inpatients and outpatients with advanced cancer should receive dedicated palliative care services, Inpatients and early inwith outpatients the disease course,cancer advanced concurrent with active should treatment. receive Referral dedicated of patientscare palliative to interdisciplinary services, For et al newly diagnosed patients with advanced cancer, 2 with comprehensive review and analyses line provides recommendations, VA 22314; review and analyses comprehensive conducted by the National of the relevant literature for each early in the disease recommendation. Additional information, Cancer Institute palliative course, care teams is concurrent optimal, with activepatient settings, andtreatment. services mayReferral complement of components of and trig existing programs. patients to Providers may interdisciplinary palliative care refer family and friend caregivers of patients with early or advanced cancer to palliative care services. with teams is optimal, and services may complement existing programs. Providers may o.org. e relevant literature for each Physicians Data Query and additional randomized including a Data Supplement offering patients palliative care, palliat mmendation. Additional information, ding a Data Supplement with ociety of Clinical the Expert refer additional evidence Panel family suggests and friendJcaregivers tables, a Methodology controlled trials (RCTs) chosen by ASCO, showing Supplement, slide sets, clinical tools and onal evidence tables, a Methodology resources, and links to patient information Clin Oncol 34. early of patients © 2016 bywith palliative earlySociety American or advanced services cancer of Clinical for family care to palliative care services. Oncology caregivers, and how o ement, slide sets, clinical tools and rces, and links to patient information ww.cancer.net, is available at www. involvement the benefits of early within 8INTRODUCTION palliative asco.org/palliative-care-guideline and www.asco.org/guidelineswiki. weeks care when of diagnosis. 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 3 from the National Consensus as those withProject (provided in 20.00 org/palliative-care-guideline and to usual oncology care. 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 Box).cancer disease, Patients distantcare, that with metastases, advanced is life limiting, inwith addition to palliat late-stage cancer and/or .asco.org/guidelineswiki. 6.70.1474 document uses theSociety definition www.jco.org. Author contributions are ors’ disclosures of potential conflicts found at the end of this article. of palliative of Clinical Oncology (ASCO) are guidelinecare defined is to update the 2012 ASCO provisional clinical prognosis as specialists. of 6 to those with 24 months. distant Inupdate This metastases, this guideline, a family c includes late-stage nine RCTs, as well as one quasiexperimental study erest are found in the article online at The purpose of this version of the American disease, cancer that is life limiting, and/or with
“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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