Early palliative care versus standard care in haematologic cancer patients at their last active treatment: study protocol of a feasibility trial.
Journal
BMC palliative care
ISSN: 1472-684X
Titre abrégé: BMC Palliat Care
Pays: England
ID NLM: 101088685
Informations de publication
Date de publication:
22 Apr 2020
22 Apr 2020
Historique:
received:
15
07
2019
accepted:
13
04
2020
entrez:
24
4
2020
pubmed:
24
4
2020
medline:
1
12
2020
Statut:
epublish
Résumé
Patients with advanced haematological malignancies suffer from a very high symptom burden and psychological, spiritual, social and physical symptoms comparable with patients with metastatic non-haematological malignancy. Referral to palliative care services for these patients remains limited or often confined to the last days of life. We developed a palliative care intervention (PCI) integrated with standard haematological care. The aim of the study was focussed on exploring the feasibility of the intervention by patients, professionals and caregivers and on assessing its preliminary efficacy. This is a mixed-methods phase 2 trial. The Specialist Palliative Care Team (SPCT) will follow each patient on a monthly basis in the outpatient clinic or will provide consultations during any hospital admission. SPCT and haematologists will discuss active patient issues to assure a team approach to the patient's care. This quantitative study is a monocentric parallel-group superiority trial with balanced randomisation comparing the experimental PCI plus haematological standard care versus haematological standard care alone. The primary endpoint will calculate on adherence to the planned PCI, measured as the percentage of patients randomised to the experimental arm who attend all the planned palliative care visits in the 24 weeks after randomisation. The qualitative study follows the methodological indications of concurrent nested design and was aimed at exploring the acceptability of the PCI from the point of view of patients, caregivers and physicians. In this trial, we will test the feasibility of an integrated palliative care approach starting when the haematologist decides to propose the last active treatment to the patient, according to his/her clinical judgement. We decided to test this criterion because it is able to intercept a wide range of patients'needs. The feasibility of this approach requires that we enrol at least 60 patients and that more than 50% of them be followed by the palliative care team for at least 24 weeks. The trial will include integrated qualitative data analysis; to give essential information on feasibility and acceptability. ClinicalTrials.gov: NCT03743480 (November 16, 2018).
Sections du résumé
BACKGROUND
BACKGROUND
Patients with advanced haematological malignancies suffer from a very high symptom burden and psychological, spiritual, social and physical symptoms comparable with patients with metastatic non-haematological malignancy. Referral to palliative care services for these patients remains limited or often confined to the last days of life. We developed a palliative care intervention (PCI) integrated with standard haematological care. The aim of the study was focussed on exploring the feasibility of the intervention by patients, professionals and caregivers and on assessing its preliminary efficacy.
METHODS/DESIGN
METHODS
This is a mixed-methods phase 2 trial. The Specialist Palliative Care Team (SPCT) will follow each patient on a monthly basis in the outpatient clinic or will provide consultations during any hospital admission. SPCT and haematologists will discuss active patient issues to assure a team approach to the patient's care. This quantitative study is a monocentric parallel-group superiority trial with balanced randomisation comparing the experimental PCI plus haematological standard care versus haematological standard care alone. The primary endpoint will calculate on adherence to the planned PCI, measured as the percentage of patients randomised to the experimental arm who attend all the planned palliative care visits in the 24 weeks after randomisation. The qualitative study follows the methodological indications of concurrent nested design and was aimed at exploring the acceptability of the PCI from the point of view of patients, caregivers and physicians.
DISCUSSION
CONCLUSIONS
In this trial, we will test the feasibility of an integrated palliative care approach starting when the haematologist decides to propose the last active treatment to the patient, according to his/her clinical judgement. We decided to test this criterion because it is able to intercept a wide range of patients'needs. The feasibility of this approach requires that we enrol at least 60 patients and that more than 50% of them be followed by the palliative care team for at least 24 weeks. The trial will include integrated qualitative data analysis; to give essential information on feasibility and acceptability.
TRIAL REGISTRATION
BACKGROUND
ClinicalTrials.gov: NCT03743480 (November 16, 2018).
Identifiants
pubmed: 32321483
doi: 10.1186/s12904-020-00561-w
pii: 10.1186/s12904-020-00561-w
pmc: PMC7178743
doi:
Banques de données
ClinicalTrials.gov
['NCT03743480']
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
53Références
Am J Clin Oncol. 1982 Dec;5(6):649-55
pubmed: 7165009
J Palliat Med. 2019 May;22(5):508-516
pubmed: 30632886
Hematology Am Soc Hematol Educ Program. 2015;2015:484-9
pubmed: 26637762
Curr Hematol Malig Rep. 2017 Aug;12(4):300-308
pubmed: 28639084
J Oncol Pract. 2015 Mar;11(2):e230-8
pubmed: 25784580
J Clin Oncol. 2016 Sep 10;34(26):3126-32
pubmed: 27400944
JAMA. 2016 Nov 22;316(20):2094-2103
pubmed: 27893130
World Health Organ Tech Rep Ser. 1990;804:1-75
pubmed: 1702248
Eur J Cancer. 2016 Dec;69:110-118
pubmed: 27821313
Support Care Cancer. 2018 Jan;26(1):241-249
pubmed: 28780728
Support Care Cancer. 1999 May;7(3):121-7
pubmed: 10335929
BMC Palliat Care. 2016 Feb 26;15:23
pubmed: 26920738
CMAJ. 2016 Jul 12;188(10):E217-E227
pubmed: 27091801
Leuk Res. 2013 Jul;37(7):731-6
pubmed: 23490030
BMJ. 2000 Sep 16;321(7262):694-6
pubmed: 10987780
J Pain Symptom Manage. 2002 Aug;24(2):91-6
pubmed: 12231124
J Pain Symptom Manage. 2017 Nov;54(5):692-700
pubmed: 28807703
Palliat Med. 2018 Jan;32(1):46-58
pubmed: 28952881
J Palliat Med. 2010 Aug;13(8):1021-5
pubmed: 20712465
J Pain Symptom Manage. 2003 Feb;25(2):150-68
pubmed: 12590031
Intern Med J. 2003 Dec;33(12):566-71
pubmed: 14656229
Palliat Med. 2011 Sep;25(6):630-41
pubmed: 21228094
J Pain Symptom Manage. 2018 Feb;55(2S):S6-S13
pubmed: 28801003
Support Care Cancer. 2006 Jan;14(1):30-7
pubmed: 15937688
BMC Cancer. 2017 Mar 23;17(1):213
pubmed: 28335744
BMJ. 2007 Mar 3;334(7591):455-9
pubmed: 17332585
Lancet Haematol. 2015 Aug;2(8):e334-8
pubmed: 26688486
Support Care Cancer. 2013 Jun;21(6):1743-50
pubmed: 23344656
J Palliat Med. 2014 Nov;17(11):1244-8
pubmed: 25390467
N Engl J Med. 2010 Aug 19;363(8):733-42
pubmed: 20818875
JAMA Intern Med. 2016 Feb;176(2):263-5
pubmed: 26720644
J Pain Symptom Manage. 2011 Sep;42(3):432-42
pubmed: 21477979
BMJ Support Palliat Care. 2017 Dec;7(4):480-484
pubmed: 28760818
Cochrane Database Syst Rev. 2017 Jun 12;6:CD011129
pubmed: 28603881
Cancer. 2014 May 15;120(10):1572-8
pubmed: 24549743
Leuk Res. 2013 Jul;37(7):725-6
pubmed: 23562287
J Palliat Med. 2013 May;16(5):537-41
pubmed: 23822210
Biol Blood Marrow Transplant. 2016 Jul;22(7):1299-1305
pubmed: 26976242