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Randomized Controlled Trial
. 2016 Jun 10;6(6):e011485.
doi: 10.1136/bmjopen-2016-011485.

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

Teresa Corbett  1 , Jane C Walsh  1 , AnnMarie Groarke  1 , Rona Moss-Morris  2 , Brian E McGuire  1
Affiliations
Randomized Controlled Trial

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

Teresa Corbett et al. BMJ Open. .

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.

Keywords: Cancer survivors; fatigue; self-regulation model.

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Figures

Figure 1
Figure 1
From theory to practice: applying the self-regulation model to a cognitive–behavioural therapy treatment model.
Figure 2
Figure 2
Planned flow of participants through the REFRESH randomised controlled trial. CBT, cognitive–behavioural therapy; REFRESH, Recovery from Cancer-Related Fatigue.
Figure 3
Figure 3
Basic structure of the REFRESH program. FAQs, Frequently Asked Questions; REFRESH, Recovery from Cancer-Related Fatigue.
Figure 4
Figure 4
Uptake and participation assessment. REFRESH, Recovery from Cancer-Related Fatigue.
Figure 5
Figure 5
Proposed assessment of self-regulation model theory.
See this image and copyright information in PMC

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