Foster, Claire; Grimmett, Chloe; May, Christine M; Ewings, Sean; Myall, Michelle; Hulme, Claire; Smith, Peter W; Powers, Cassandra; Calman, Lynn; Armes, Jo; +12 more... Breckons, Matthew; Corner, Jessica; Fenlon, Deborah; Batehup, Lynn; Lennan, Elaine; R May, Carl; Morris, Carolyn; Neylon, Amanda; Ream, Emma; Turner, Lesley; Yardley, Lucy; Richardson, Alison; (2016) 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. SUPPORTIVE CARE IN CANCER, 24 (6). pp. 2445-2453. ISSN 0941-4355 DOI: https://doi.org/10.1007/s00520-015-3044-7
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Abstract
PURPOSE: Cancer-related fatigue (CRF) is a frequent and distressing symptom experienced after cancer treatment. RESTORE is the first web-based resource designed to enhance self-efficacy to manage CRF following curative-intent treatment. The aim of this study is to test the proof of concept and inform the design of an effectiveness trial. METHODS: A multi-centre parallel-group two-armed (1:1) exploratory randomised controlled trial (RCT) with qualitative process evaluation was employed in the study. Participants (≥18 years; ≤5 years post treatment with moderate to severe fatigue) were recruited and randomly assigned to RESTORE or a leaflet. Feasibility and acceptability were measured by recruitment, attrition, intervention adherence, completion of outcome measures and process evaluation. Change in self-efficacy to manage CRF was also explored. Outcome measures were completed at baseline (T0), 6 weeks (T1) and 12 weeks (T2). Data were analysed using mixed-effects linear regression and directed content analysis. RESULTS: One hundred and sixty-three people participated in the trial and 19 in the process evaluation. The intervention was feasible (39 % of eligible patients consented) and acceptable (attrition rate 36 %). There was evidence of higher fatigue self-efficacy at T1 in the intervention group vs comparator (mean difference 0.51 [-0.08 to 1.11]), though the difference in groups decreased by 12 weeks. Time since diagnosis influenced perceived usefulness of the intervention. Modifications were suggested. CONCLUSION: Proof of concept was achieved. The RESTORE intervention should be subject to a definitive trial with some adjustments. Provision of an effective supportive resource would empower cancer survivors to manage CRF after treatment completion. TRIAL REGISTRATION: ISRCTN67521059.
Item Type | Article |
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Faculty and Department | Faculty of Public Health and Policy > Dept of Health Services Research and Policy |
PubMed ID | 26643072 |
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Licence: Creative Commons: Attribution-Noncommercial-No Derivative Works 3.0
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