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

Research output: Contribution to journalArticle (Academic Journal)peer-review

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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.

Original languageEnglish
Pages (from-to)2445-53
Number of pages9
JournalSupportive Care in Cancer
Volume24
Issue number6
Early online date7 Dec 2015
DOIs
Publication statusPublished - Jun 2016

Structured keywords

  • Physical and Mental Health
  • Digital Health

Keywords

  • Adult
  • Aged
  • Fatigue/etiology
  • Female
  • Humans
  • Internet
  • Male
  • Middle Aged
  • Neoplasms/complications
  • Perception
  • Self Care/methods
  • Self Efficacy
  • Survivors

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