Efficacy and cost-utility of the eHealth self-management application 'Oncokompas', helping partners of patients with incurable cancer to identify their unmet supportive care needs and to take actions to meet their needs: a study protocol of a randomized controlled trial.
Adaptation, Psychological
Adult
Caregivers
/ education
Cost-Benefit Analysis
Education, Distance
/ methods
Female
Humans
Male
Mobile Applications
/ economics
Neoplasms
/ psychology
Procedures and Techniques Utilization
Psychosocial Support Systems
Randomized Controlled Trials as Topic
Self-Management
/ education
Spouses
/ education
Telemedicine
/ economics
Caregiver burden
Caregiving
Incurable cancer
Partners
Self-management
eHealth
Journal
Trials
ISSN: 1745-6215
Titre abrégé: Trials
Pays: England
ID NLM: 101263253
Informations de publication
Date de publication:
31 Jan 2020
31 Jan 2020
Historique:
received:
29
09
2019
accepted:
29
12
2019
entrez:
2
2
2020
pubmed:
2
2
2020
medline:
20
11
2020
Statut:
epublish
Résumé
Incurable cancer does not only affect patients, it also affects the lives of their partners. Many partners take on caregiving responsibilities. The burden of these caregiving tasks are often associated with physical, psychological, and social difficulties and many partners have unmet supportive care needs. Oncokompas is an eHealth self-management application to support partners in finding and obtaining optimal supportive care, tailored to their quality of life and personal preferences. A randomized controlled trial will be carried out to determine the efficacy and cost-utility of Oncokompas. A total of 136 adult partners of patients with incurable cancer will be included. Partners will be randomly assigned to the intervention group, which directly gets access to Oncokompas, or the waiting-list control group, which gets access to Oncokompas after three months. The primary outcome measure is caregiver burden. Secondary outcome measures comprise self-efficacy, health-related quality of life, and costs. Measures will be assessed at baseline, two weeks after randomization, and three months after the baseline measurement. This study will result in evidence on the efficacy and cost-utility of Oncokompas among partners of patients with incurable cancer, which might lead to implementation of Oncokompas as a health service for partners of patients with incurable cancer. Netherlands Trial Register, NTR 7636. Registered on 23 November 2018.
Sections du résumé
BACKGROUND
BACKGROUND
Incurable cancer does not only affect patients, it also affects the lives of their partners. Many partners take on caregiving responsibilities. The burden of these caregiving tasks are often associated with physical, psychological, and social difficulties and many partners have unmet supportive care needs. Oncokompas is an eHealth self-management application to support partners in finding and obtaining optimal supportive care, tailored to their quality of life and personal preferences. A randomized controlled trial will be carried out to determine the efficacy and cost-utility of Oncokompas.
METHODS
METHODS
A total of 136 adult partners of patients with incurable cancer will be included. Partners will be randomly assigned to the intervention group, which directly gets access to Oncokompas, or the waiting-list control group, which gets access to Oncokompas after three months. The primary outcome measure is caregiver burden. Secondary outcome measures comprise self-efficacy, health-related quality of life, and costs. Measures will be assessed at baseline, two weeks after randomization, and three months after the baseline measurement.
DISCUSSION
CONCLUSIONS
This study will result in evidence on the efficacy and cost-utility of Oncokompas among partners of patients with incurable cancer, which might lead to implementation of Oncokompas as a health service for partners of patients with incurable cancer.
TRIAL REGISTRATION
BACKGROUND
Netherlands Trial Register, NTR 7636. Registered on 23 November 2018.
Identifiants
pubmed: 32005280
doi: 10.1186/s13063-019-4037-5
pii: 10.1186/s13063-019-4037-5
pmc: PMC6995084
doi:
Types de publication
Clinical Trial Protocol
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
124Subventions
Organisme : ZonMw
ID : 844001105
Références
Support Care Cancer. 2014 Jun;22(6):1637-46
pubmed: 24496758
Support Care Cancer. 2016 May;24(5):2163-2171
pubmed: 26563178
Support Care Cancer. 2019 Apr;27(4):1187-1195
pubmed: 30209602
CA Cancer J Clin. 2010 Sep-Oct;60(5):317-39
pubmed: 20709946
Support Care Cancer. 2010 Sep;18(9):1123-36
pubmed: 20336326
Acta Oncol. 2015 Apr;54(4):500-6
pubmed: 25291079
BMC Cancer. 2014 Jul 28;14:541
pubmed: 25069703
Pharmacoeconomics. 2015 Feb;33(2):123-35
pubmed: 25315368
Eur J Cancer. 2003 Jul;39(11):1517-24
pubmed: 12855257
JAMA. 2012 Jan 25;307(4):398-403
pubmed: 22274687
CA Cancer J Clin. 2011 Jan-Feb;61(1):50-62
pubmed: 21205833
BMC Palliat Care. 2019 Oct 23;18(1):85
pubmed: 31647011
Health Econ. 1994 Sep-Oct;3(5):309-19
pubmed: 7827647
J Clin Oncol. 2007 Oct 20;25(30):4829-34
pubmed: 17947732
CA Cancer J Clin. 2001 Jul-Aug;51(4):213-31
pubmed: 11577488
Support Care Cancer. 2017 Mar;25(3):965-971
pubmed: 27866337
Palliat Support Care. 2013 Jun;11(3):231-52
pubmed: 23046977
Qual Life Res. 2013 Sep;22(7):1717-27
pubmed: 23184421
Cancer Nurs. 2006 Sep-Oct;29(5):378-88; quiz 389-90
pubmed: 17006111
J Palliat Med. 2006 Aug;9(4):912-21
pubmed: 16910806
Res Nurs Health. 2011 Dec;34(6):483-95
pubmed: 21953274
Ann Behav Med. 2015 Dec;49(6):901-11
pubmed: 26489843
Support Care Cancer. 2016 Jul;24(7):3011-22
pubmed: 26879825
J Med Internet Res. 2015 Oct 21;17(10):e235
pubmed: 26489918
Asian Pac J Cancer Prev. 2014;15(2):725-9
pubmed: 24568486
Int J Med Inform. 2016 Mar;87:54-67
pubmed: 26806712
Qual Life Res. 2011 Dec;20(10):1727-36
pubmed: 21479777
J Psychosoc Oncol. 2018 Mar-Apr;36(2):203-221
pubmed: 29336704
J Med Internet Res. 2011 Dec 05;13(4):e111
pubmed: 22155738
Semin Oncol Nurs. 2012 Nov;28(4):205-12
pubmed: 23107177
J Clin Nurs. 2015 May;24(9-10):1367-79
pubmed: 25677218
Psychooncology. 2013 Feb;22(2):403-10
pubmed: 22135229
Cancer. 2015 May 1;121(9):1513-9
pubmed: 25677095
BMC Palliat Care. 2018 Jul 23;17(1):96
pubmed: 30037346
BMJ Support Palliat Care. 2012 Sep;2(3):224-30
pubmed: 24654195
Psychooncology. 2013 Nov;22(11):2399-407
pubmed: 23712938
J Health Econ. 1995 Jun;14(2):171-89
pubmed: 10154656
Gerontologist. 1986 Jun;26(3):260-6
pubmed: 3721233
J Pain Symptom Manage. 1999 Jun;17(6):418-28
pubmed: 10388247
Value Health. 2016 Jun;19(4):343-52
pubmed: 27325326
Semin Oncol Nurs. 2010 Nov;26(4):243-58
pubmed: 20971405
Psychooncology. 2013 Jul;22(7):1557-64
pubmed: 22941765
Psychooncology. 2010 Oct;19(10):1013-25
pubmed: 20014159
Int J Nurs Stud. 2010 Aug;47(8):984-93
pubmed: 20116060
J Gerontol. 1983 May;38(3):344-8
pubmed: 6841931