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Protocol for a pilot randomised controlled trial of an online intervention for post-treatment cancer survivors with persistent fatigue

Protocol for a pilot randomised controlled trial of an online intervention for post-treatment cancer survivors with persistent fatigue
Protocol for a pilot randomised controlled trial of an online intervention for post-treatment cancer survivors with persistent fatigue

INTRODUCTION: Many post-treatment cancer survivors experience persistent fatigue that can disrupt attempts to resume normal everyday activities after treatment. Theoretical models that aim to explain contributory factors that initiate and sustain fatigue symptoms, or that influence the efficacy of interventions for cancer-related fatigue (CrF) require testing. Adjustment to fatigue is likely to be influenced by coping behaviours that are guided by the representations of the symptom.

OBJECTIVES: This paper describes the protocol for a pilot trial of a systematically and theoretically designed online intervention to enable self-management of CrF after cancer treatment.

METHODS AND ANALYSIS: This 2-armed randomised controlled pilot trial will study the feasibility and potential effectiveness of an online intervention. Participants will be allocated to either the online intervention (REFRESH (Recovery from Cancer-Related Fatigue)), or a leaflet comparator.

PARTICIPANTS: 80 post-treatment cancer survivors will be recruited for the study.

INTERVENTIONS: An 8-week online intervention based on cognitive-behavioural therapy.

PRIMARY AND SECONDARY OUTCOME MEASURES: The primary outcome is a change in fatigue as measured by the Piper Fatigue Scale (revised). Quality of life will be measured using the Quality of Life in Adult Survivors of Cancer Scale. Outcome measures will be collected at baseline, and at completion of intervention.

RESULTS: The feasibility of trial procedures will be tested, as well as the effect of the intervention on the outcomes.

CONCLUSIONS: This study may lead to the development of a supportive resource to target representations and coping strategies of cancer survivors with CrF post-treatment.

SETTING: Recruitment from general public in Ireland.

ETHICS AND DISSEMINATION: This trial was approved by the Research Ethics Committee at National University of Ireland Galway in January 2013. Trial results will be communicated in a peer-reviewed journal.

TRIAL REGISTRATION NUMBER: ISRCTN55763085; Pre-results.

Journal Article
2044-6055
e011485
Corbett, Teresa
bce81837-17ae-46c3-a6b1-43a7e1f07f9c
Walsh, Jane C
1a670745-ae16-41df-809e-4c6e2f91e37e
Groarke, AnnMarie
cd00c51a-ae4b-48f8-9683-b66530a56578
Moss-Morris, Rona
a502f58a-d319-49a6-8aea-9dde4efc871e
McGuire, Brian E
739bbbb7-b90f-4199-8e2f-c4840eaf2e89
Corbett, Teresa
bce81837-17ae-46c3-a6b1-43a7e1f07f9c
Walsh, Jane C
1a670745-ae16-41df-809e-4c6e2f91e37e
Groarke, AnnMarie
cd00c51a-ae4b-48f8-9683-b66530a56578
Moss-Morris, Rona
a502f58a-d319-49a6-8aea-9dde4efc871e
McGuire, Brian E
739bbbb7-b90f-4199-8e2f-c4840eaf2e89

Corbett, Teresa, Walsh, Jane C, Groarke, AnnMarie, Moss-Morris, Rona and McGuire, Brian E (2016) Protocol for a pilot randomised controlled trial of an online intervention for post-treatment cancer survivors with persistent fatigue. BMJ Open, 6 (6), e011485. (doi:10.1136/bmjopen-2016-011485).

Record type: Article

Abstract

INTRODUCTION: Many post-treatment cancer survivors experience persistent fatigue that can disrupt attempts to resume normal everyday activities after treatment. Theoretical models that aim to explain contributory factors that initiate and sustain fatigue symptoms, or that influence the efficacy of interventions for cancer-related fatigue (CrF) require testing. Adjustment to fatigue is likely to be influenced by coping behaviours that are guided by the representations of the symptom.

OBJECTIVES: This paper describes the protocol for a pilot trial of a systematically and theoretically designed online intervention to enable self-management of CrF after cancer treatment.

METHODS AND ANALYSIS: This 2-armed randomised controlled pilot trial will study the feasibility and potential effectiveness of an online intervention. Participants will be allocated to either the online intervention (REFRESH (Recovery from Cancer-Related Fatigue)), or a leaflet comparator.

PARTICIPANTS: 80 post-treatment cancer survivors will be recruited for the study.

INTERVENTIONS: An 8-week online intervention based on cognitive-behavioural therapy.

PRIMARY AND SECONDARY OUTCOME MEASURES: The primary outcome is a change in fatigue as measured by the Piper Fatigue Scale (revised). Quality of life will be measured using the Quality of Life in Adult Survivors of Cancer Scale. Outcome measures will be collected at baseline, and at completion of intervention.

RESULTS: The feasibility of trial procedures will be tested, as well as the effect of the intervention on the outcomes.

CONCLUSIONS: This study may lead to the development of a supportive resource to target representations and coping strategies of cancer survivors with CrF post-treatment.

SETTING: Recruitment from general public in Ireland.

ETHICS AND DISSEMINATION: This trial was approved by the Research Ethics Committee at National University of Ireland Galway in January 2013. Trial results will be communicated in a peer-reviewed journal.

TRIAL REGISTRATION NUMBER: ISRCTN55763085; Pre-results.

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More information

Accepted/In Press date: 18 May 2016
e-pub ahead of print date: 10 June 2016
Published date: 10 June 2016
Additional Information: Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/
Keywords: Journal Article

Identifiers

Local EPrints ID: 414058
URI: https://eprints.soton.ac.uk/id/eprint/414058
ISSN: 2044-6055
PURE UUID: aae7be05-8d31-49d0-aaed-393951f47a10
ORCID for Teresa Corbett: ORCID iD orcid.org/0000-0002-5620-5377

Catalogue record

Date deposited: 13 Sep 2017 16:31
Last modified: 14 Mar 2019 01:31

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