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Supportive Care in Cancer
Published in: Supportive Care in Cancer 6/2016

Open Access 01-06-2016 | Original Article

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

Authors: 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 Turner, Lucy Yardley, Alison Richardson

Published in: Supportive Care in Cancer | Issue 6/2016

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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

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Metadata
Title
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
Authors
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 Turner
Lucy Yardley
Alison Richardson
Publication date
01-06-2016
Publisher
Springer Berlin Heidelberg
Published in
Supportive Care in Cancer / Issue 6/2016
Print ISSN: 0941-4355
Electronic ISSN: 1433-7339
DOI
https://doi.org/10.1007/s00520-015-3044-7

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