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

Claire Foster*, Chloe Grimmett, Christine M. May, Sean Ewings, Michelle Myall, Claire Hulme, Peter W. Smith, Cassandra Powers, Lynn Calman, Jo Armes, Matthew Breckons, Jessica Corner, Deborah Fenlon, Lynn Batehup, Elaine Lennan, Carl R. May, Carolyn Morris, Amanda Neylon, Emma Ream, Lesley TurnerLucy Yardley, Alison Richardson

*Corresponding author for this work

Research output: Contribution to journalArticlepeer-review

47 Citations (Scopus)

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

Original languageEnglish
Pages (from-to)2445-2453
Number of pages9
JournalSupportive Care in Cancer
Volume24
Issue number6
DOIs
Publication statusPublished - 1 Jun 2016
Externally publishedYes

Bibliographical note

Funding Information:
The study was funded by Macmillan Cancer Support as part of the Macmillan Survivorship Research Group programme. We thank the participants and clinicians and their teams who contributed to this study. We also thank members of the Macmillan Survivorship Research Group who supported the study and members of the Trial Steering Committee.

Funding Information:
The study was funded by Macmillan Cancer Support as part of the Macmillan Survivorship Research Group programme. We thank the participants and clinicians and their teams who contributed to this study. We also thank members of the Macmillan Survivorship Research Group who supported the study and members of the Trial Steering Committee.

Publisher Copyright:
© 2015, The Author(s).

Keywords

  • Cancer
  • Fatigue
  • Intervention
  • Self-management
  • Web-based

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