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.