Renewed: Protocol for a randomised controlled trial of a digital intervention to support quality of life in cancer survivors.
cancer
digital interventions
ehealth
psycho-oncology
quality of life
survivorship
Journal
BMJ open
ISSN: 2044-6055
Titre abrégé: BMJ Open
Pays: England
ID NLM: 101552874
Informations de publication
Date de publication:
01 03 2019
01 03 2019
Historique:
entrez:
4
3
2019
pubmed:
4
3
2019
medline:
28
3
2020
Statut:
epublish
Résumé
Low quality of life is common in cancer survivors. Increasing physical activity, improving diet, supporting psychological well-being and weight loss can improve quality of life in several cancers and may limit relapse. The aim of the randomised controlled trial outlined in this protocol is to examine whether a digital intervention (Renewed), with or without human support, can improve quality of life in cancer survivors. Renewed provides support for increasing physical activity, managing difficult emotions, eating a healthier diet and weight management. A randomised controlled trial is being conducted comparing usual care, access to Renewed or access to Renewed with brief human support. Cancer survivors who have had colorectal, breast or prostate cancer will be identified and invited through general practice searches and mail-outs. Participants are asked to complete baseline measures immediately after screening and will then be randomised to a study group; this is all completed on the Renewed website. The primary outcome is quality of life measured by the European Organization for Research and Treatment of Cancer QLQ-c30. Secondary outcomes include anxiety and depression, fear of cancer recurrence, general well-being, enablement and items relating to costs for a health economics analysis. Process measures include perceptions of human support, intervention usage and satisfaction, and adherence to behavioural changes. Qualitative process evaluations will be conducted with patients and healthcare staff providing support. The trial has been approved by the NHS Research Ethics Committee (Reference 18/NW/0013). The results of this trial will be published in peer-reviewed journals and through conference presentations. ISRCTN96374224; Pre-results.
Identifiants
pubmed: 30826763
pii: bmjopen-2018-024862
doi: 10.1136/bmjopen-2018-024862
pmc: PMC6429898
doi:
Banques de données
ISRCTN
['ISRCTN96374224']
Types de publication
Clinical Trial Protocol
Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
e024862Informations de copyright
© Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY. Published by BMJ.
Déclaration de conflit d'intérêts
Competing interests: None declared.
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