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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

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
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
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.
cancer, fatigue, web-based, self-management, intervention
0941-4355
2445-2453
Foster, Claire
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Grimmett, Chloe
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May, Christine M.
227ab47a-1ca0-4437-905a-bd90feacc3d5
Ewings, Sean
e7a5c2e1-49f0-43ac-acdc-0fe40b9851fb
Myall, Michelle
0604ba0f-75c2-4783-9afe-aa54bf81513f
Hulme, Claire
41450d4a-8ec9-47f8-9a0b-038fff349203
Smith, Peter W.
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Powers, Cassandra
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Calman, Lynn
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Armes, Jo
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Breckons, Matthew
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Corner, Jessica
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Fenlon, Deborah
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Batehup, Lynn
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Lennan, Elaine
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May, Carl R.
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Morris, Carolyn
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Neylon, Amanda
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Ream, Emma
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Turner, Lesley
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Yardley, Lucy
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Richardson, Alison
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Foster, Claire
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Grimmett, Chloe
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May, Christine M.
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Ewings, Sean
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Myall, Michelle
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Hulme, Claire
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Smith, Peter W.
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Powers, Cassandra
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Calman, Lynn
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Armes, Jo
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Breckons, Matthew
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Corner, Jessica
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Fenlon, Deborah
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Batehup, Lynn
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Lennan, Elaine
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May, Carl R.
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Morris, Carolyn
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Neylon, Amanda
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Ream, Emma
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Turner, Lesley
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Yardley, Lucy
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Richardson, Alison
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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 and Richardson, Alison (2016) 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, 24 (6), 2445-2453. (doi:10.1007/s00520-015-3044-7). (PMID:26643072)

Record type: Article

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.

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More information

Accepted/In Press date: 23 November 2015
e-pub ahead of print date: 7 December 2015
Published date: June 2016
Keywords: cancer, fatigue, web-based, self-management, intervention
Organisations: Faculty of Health Sciences

Identifiers

Local EPrints ID: 386948
URI: http://eprints.soton.ac.uk/id/eprint/386948
ISSN: 0941-4355
PURE UUID: 0e4d0d98-c8b6-4416-8b1a-535e882d3031
ORCID for Claire Foster: ORCID iD orcid.org/0000-0002-4703-8378
ORCID for Chloe Grimmett: ORCID iD orcid.org/0000-0002-7540-7206
ORCID for Michelle Myall: ORCID iD orcid.org/0000-0001-8733-7412
ORCID for Peter W. Smith: ORCID iD orcid.org/0000-0003-4423-5410
ORCID for Lynn Calman: ORCID iD orcid.org/0000-0002-9964-6017
ORCID for Carl R. May: ORCID iD orcid.org/0000-0002-0451-2690
ORCID for Lucy Yardley: ORCID iD orcid.org/0000-0002-3853-883X
ORCID for Alison Richardson: ORCID iD orcid.org/0000-0003-3127-5755

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Date deposited: 05 Feb 2016 15:12
Last modified: 15 Mar 2024 03:43

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Contributors

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

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