International oncology societies recommend early palliative care. Specific models to integrate early palliative care efficiently into clinical practice are debated. The authors designed a study to look at the quantitative and qualitative outcomes of an early palliative care intervention in oncological care to decrease stress and improve quality of life.
Aims:
To compare a single structured early palliative care intervention added to a usual oncology care in terms of distress and health-related quality of life at baseline compared to 6 months after enrollment.
Design:
This multicenter randomized controlled trial (NCT01983956) enrolled adult patients with advanced cancer. Participants were either randomly assigned to usual oncology care alone or usual care plus a structured early palliative care intervention.
Setting/participants:
One hundred fifty adult patients with a variety of advanced cancer diagnoses were randomized. Seventy-four participants were in the intervention and 76 participants in the control group. The primary outcome was the change in patient distress assessed by the National Comprehensive Cancer Network distress thermometer at 6 months. Health-related quality of life, the secondary outcome, was assessed by the Functional Assessment of Cancer Therapy–General Questionnaire.
Results:
The results showed no significant effect of the early palliative care intervention neither on patient distress nor on health-related quality of life.
Conclusion:
The addition of an early intervention to usual care for patients with advanced cancer did not improve distress or quality of life. Thus, patients may need more intensive early palliative care with continuous professional support to identify and address their palliative needs early.
HaunMWEstelSRuckerG, et al. Early palliative care for adults with advanced cancer. Cochrane Database Syst Rev2017; 6: CD011129.
2.
VanbutseleGPardonKVan BelleS, et al. Effect of early and systematic integration of palliative care in patients with advanced cancer: a randomised controlled trial. Lancet Oncol2018; 19(3): 394–404.
3.
FerrellBRTemelJSTeminS, et al. Integration of palliative care into standard oncology care: ASCO clinical practice guideline update summary. J Oncol Pract2017; 13(2): 119–121.
4.
SchrijversDChernyNI and Group EGW. ESMO clinical practice guidelines on palliative care: advanced care planning. Ann Oncol2014; 25(Suppl. 3): iii138–iii142.
5.
TemelJSGreerJAMuzikanskyA, et al. Early palliative care for patients with metastatic non-small-cell lung cancer. N Engl J Med2010; 363(8): 733–742.
6.
BakitasMATostesonTDLiZ, et al. Early versus delayed initiation of concurrent palliative oncology care: patient outcomes in the ENABLE III randomized controlled trial. J Clin Oncol2015; 33(13): 1438–1445.
7.
NordlyMSkov BenthienKVadstrupES, et al. Systematic fast-track transition from oncological treatment to dyadic specialized palliative home care: DOMUS - a randomized clinical trial. Palliat Med2019; 33(2): 135–149.
8.
MaltoniMScarpiEDall’AgataM, et al. Systematic versus on-demand early palliative care: a randomised clinical trial assessing quality of care and treatment aggressiveness near the end of life. Eur J Cancer2016; 69: 110–118.
9.
GidwaniRJoyceNKinosianB, et al. Gap between recommendations and practice of palliative care and hospice in cancer patients. J Palliat Med2016; 19(9): 957–963.
10.
MaselEKSchurSNemecekR, et al. Palliative care units in lung cancer in the real-world setting: a single institution’s experience and its implications. Ann Palliat Med2017; 6(1): 6–13.
11.
KaasaSLogeJHAaproM, et al. Integration of oncology and palliative care: a lancet oncology commission. Lancet Oncol2018; 19(11): e588–e653.
12.
BlockSDBillingsJA.A need for scalable outpatient palliative care interventions. Lancet2014; 383(9930): 1699–1700.
13.
TemelJSGreerJAEl-JawahriA, et al. Effects of early integrated palliative care in patients with lung and GI cancer: a randomized clinical trial. J Clin Oncol. 2017;35(8):834-41.
14.
HoergerMGreerJAJacksonVA, et al. Defining the elements of early palliative care that are associated with patient-reported outcomes and the delivery of end-of-life care. J Clin Oncol2018; 36(11): 1096–1102.
15.
HuiDBrueraE.Models of palliative care delivery for patients with cancer. J Clin Oncol2020; 38(9): 852–865.
16.
HuiDHannonBLZimmermannC, et al. Improving patient and caregiver outcomes in oncology: team-based, timely, and targeted palliative care. CA Cancer J Clin2018; 65(8): 356–376.
17.
FliednerMCMitchellGBuecheD, et al. Development and use of the ‘SENS’-structure to proactively identify care needs in early palliative care-an innovative approach. Healthcare (Basel)2019; 7(1): 32.
18.
EychmuellerS.SENS is making sense - on the way to an innovative approach to structure palliative care problems. Ther Umsch2012; 69(2): 87–90.
19.
FliednerMZambranoSScholsJM, et al. An early palliative care intervention can be confronting but reassuring: a qualitative study on the experiences of patients with advanced cancer. Palliat Med2019; 33(7): 783–792.
20.
MitchellAJ.Pooled results from 38 analyses of the accuracy of distress thermometer and other ultra-short methods of detecting cancer-related mood disorders. J Clin Oncol2007; 25(29): 4670–4681.
21.
RibaMBDonovanKAAndersenB, et al. Distress management, Version 3.2019, NCCN clinical practice guidelines in oncology. J Natl Compr Canc Netw2019; 17(10): 1229–1249.
22.
MehnertAMüllerDLehmannC, et al. Die deutsche Version des NCCN distress-thermometers. Z Klin Psychol Psychiatr Psychother2006; 54(3): 213–223.
23.
MaXZhangJZhongW, et al. The diagnostic role of a short screening tool—the distress thermometer: a meta-analysis. Support Care Cancer2014; 22(7): 1741–1755.
24.
BonnetainFBorgCAdamsRR, et al. How health-related quality of life assessment should be used in advanced colorectal cancer clinical trials. Ann Oncol2017; 28(9): 2077–2085.
25.
U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER), Center for Biologics Evaluation and Research (CBER). Guidance for industry - Clinical trial endpoints for the approval of cancer drugs and biologics. Rockville, MD, 2007.
26.
CellaDHahnEADineenK.Meaningful change in cancer-specific quality of life scores: differences between improvement and worsening. Qual Life Res2002; 11(3): 207–221.
27.
HearnJHigginsonIJ.Development and validation of a core outcome measure for palliative care: the palliative care outcome scale. Palliative Care Core Audit Project Advisory Group. Qual Health Care1999; 8(4): 219–227.
28.
LubbenJBlozikEGillmannG, et al. Performance of an abbreviated version of the Lubben Social Network Scale among three European community-dwelling older adult populations. Gerontologist2006; 46(4): 503–13.
29.
BakenDMWoolleyC.Validation of the distress thermometer, impact thermometer and combinations of these in screening for distress. Psychooncology2011; 20(6): 609–14.
30.
HeadBASchapmireTJKeeneyCE, et al. Use of the distress thermometer to discern clinically relevant quality of life differences in women with breast cancer. Qual Life Res2012; 21(2): 215–223.
31.
FaircloughDLCellaDF.Functional assessment of cancer therapy (FACT-G): non-response to individual questions. Qual Life Res1996; 5(3): 321–329.
32.
MoherDSchulzKFAltmanDG.The CONSORT statement: revised recommendations for improving the quality of reports of parallel-group randomised trials. Lancet2001; 357(9263): 1191–1194.
33.
FerrellBRTemelJSTeminS, et al. Integration of palliative care into standard oncology care: American society of clinical oncology clinical practice guideline update. J Clin Oncol2017; 35(1): 96–112.
ZimmermannCSwamiNKrzyzanowskaM, et al. Early palliative care for patients with advanced cancer: a cluster-randomised controlled trial. Lancet2014; 383(9930): 1721–1730.
36.
RevickiDHaysRDCellaD, et al. Recommended methods for determining responsiveness and minimally important differences for patient-reported outcomes. J Clin Epidemiol2008; 61(2): 102–109.
37.
BernardMBerchtoldAStrasserF, et al. Meaning in life and quality of life: palliative care patients versus the general population. BMJ Support Palliat Care. Epub ahead of print 6 July 2020. DOI: 10.1136/bmjspcare-2020-002211.
38.
OwnbyKK.Use of the distress thermometer in clinical practice. J Adv Pract Oncol2019; 10(2): 175–179.
39.
GaertnerJSiemensWMeerpohlJJ, et al. Effect of specialist palliative care services on quality of life in adults with advanced incurable illness in hospital, hospice, or community settings: systematic review and meta-analysis. BMJ2017; 357: j2925.
