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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

Lookup NU author(s): Christine May, Dr Matthew Breckons, Professor Carl May

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This work is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License (CC BY-NC 4.0).


Abstract

PurposeCancer-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 (a parts per thousand yen18 years; a parts per thousand currency sign5 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.


Publication metadata

Author(s): Foster C, Grimmett C, May CM, Ewings S, Myall M, Hulme C, Smith PW, Powers C, Calman L, Armes J, Breckons M, Corner J, Fenlon D, Batehup L, Lennan E, May CR, Morris C, Neylon A, Ream E, Turner L, Yardley L, Richardson A

Publication type: Article

Publication status: Published

Journal: Supportive Care in Cancer

Year: 2016

Volume: 24

Issue: 6

Pages: 2445-2453

Print publication date: 01/06/2016

Online publication date: 07/12/2015

Acceptance date: 23/11/2015

ISSN (print): 0941-4355

ISSN (electronic): 1433-7339

Publisher: Springer

URL: http://dx.doi.org/10.1007/s00520-015-3044-7

DOI: 10.1007/s00520-015-3044-7


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