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A web-based intervention (RESTORE) to support self-management of cancer-related fatigue following primary cancer treatment: a multi-centre proof of concept randomised controlled trial
C Foster, C Grimmett, CM May, S Ewings, M Myall, C Hulme, PW Smith, C Powers, L Calman, J Armes, M Breckons, J Corner, D Fenlon, L Batehup, E Lennan, May R, C Morris, A Neylon, E Ream, L Turner, L Yardley, A Richardson, Deborah Fenlon
Supportive Care in Cancer, Volume: 24, Issue: 6, Pages: 2445 - 2453
Swansea University Author: Deborah Fenlon
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DOI (Published version): 10.1007/s00520-015-3044-7
Purpose Cancer-related fatigue (CRF) is a frequent anddistressing symptom experienced after cancer treatment.RESTORE is the first web-based resource designed to enhanceself-efficacy to manage CRF following curative-intenttreatment. The aim of this study is to test the proof of conceptand inform the...
|Published in:||Supportive Care in Cancer|
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Purpose Cancer-related fatigue (CRF) is a frequent anddistressing symptom experienced after cancer treatment.RESTORE is the first web-based resource designed to enhanceself-efficacy to manage CRF following curative-intenttreatment. The aim of this study is to test the proof of conceptand inform the design of an effectiveness trial.Methods A multi-centre parallel-group two-armed (1:1) exploratoryrandomised controlled trial (RCT) with qualitativeprocess evaluation was employed in the study. Participants(≥18 years; ≤5 years post treatment with moderate to severefatigue) were recruited and randomly assigned to RESTOREor a leaflet. Feasibility and acceptability were measured byrecruitment, attrition, intervention adherence, completion ofoutcome measures and process evaluation. Change in selfefficacyto manage CRF was also explored. Outcome measureswere completed at baseline (T0), 6 weeks (T1) and12 weeks (T2). Data were analysed using mixed-effects linearregression and directed content analysis.Results One hundred and sixty-three people participated inthe trial and 19 in the process evaluation. The interventionwas feasible (39 % of eligible patients consented) and acceptable(attrition rate 36 %). There was evidence of higher fatigueself-efficacy at T1 in the intervention group vs comparator(mean difference 0.51 [−0.08 to 1.11]), though the differencein groups decreased by 12 weeks. Time since diagnosis influencedperceived usefulness of the intervention. Modificationswere suggested.Conclusion Proof of concept was achieved. The RESTOREintervention should be subject to a definitive trial with some adjustments.Provision of an effective supportive resource would empower cancersurvivors to manage CRF after treatment completion.
Faculty of Medicine, Health and Life Sciences