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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

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

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

Deborah Fenlon

Lynn Batehup

Elaine Lennan

Carl R. May

Carolyn Morris

Amanda Neylon

Emma Ream

Lesley Turner

Lucy Yardley

Alison Richardson



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.

Citation

Foster, C., Grimmett, C., May, C. M., Ewings, S., Myall, M., Hulme, C., …Richardson, A. (2015). 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. Supportive Care in Cancer, doi:10.1007/s00520-015-3044-7

Journal Article Type Article
Publication Date Dec 7, 2015
Deposit Date Feb 5, 2016
Publicly Available Date Mar 21, 2016
Journal Supportive Care in Cancer
Print ISSN 0941-4355
Electronic ISSN 1433-7339
Publisher Humana Press
Peer Reviewed Peer Reviewed
DOI https://doi.org/10.1007/s00520-015-3044-7
Keywords cancer, fatigue, web-based, self-management, intervention
Public URL http://eprints.nottingham.ac.uk/id/eprint/32436
Publisher URL http://link.springer.com/article/10.1007%2Fs00520-015-3044-7
Copyright Statement Copyright information regarding this work can be found at the following address: http://creativecommons.org/licenses/by/4.0

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Copyright Statement
Copyright information regarding this work can be found at the following address: http://creativecommons.org/licenses/by/4.0





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