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Randomized Controlled Trial
. 2016 Jun;24(6):2445-53.
doi: 10.1007/s00520-015-3044-7. Epub 2015 Dec 7.

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  1 , Chloe Grimmett  2 , Christine M May  2 , Sean Ewings  3 , Michelle Myall  2 , Claire Hulme  4 , Peter W Smith  3 , Cassandra Powers  2 , Lynn Calman  2 , Jo Armes  5 , Matthew Breckons  6 , Jessica Corner  7 , Deborah Fenlon  7 , Lynn Batehup  7 , Elaine Lennan  8 , Carl R May  7 , Carolyn Morris  9 , Amanda Neylon  10 , Emma Ream  11 , Lesley Turner  9 , Lucy Yardley  12 , Alison Richardson  7   8
Affiliations
Randomized Controlled Trial

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 et al. Support Care Cancer. 2016 Jun.

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.

Keywords: Cancer; Fatigue; Intervention; Self-management; Web-based.

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