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.
['Corbett|Teresa|T|', 'Walsh|Jane C|JC|', 'Groarke|AnnMarie|A|', 'Moss-Morris|Rona|R|', 'McGuire|Brian E|BE|']
D000223:Adaptation, Psychological D000293:Adolescent D000328:Adult D000368:Aged D000073116:Cancer Survivors D015928:Cognitive Behavioral Therapy D005221:Fatigue D005260:Female D006801:Humans D020407:Internet D007494:Ireland D008297:Male D008875:Middle Aged D008962:Models, Theoretical D009369:Neoplasms D010865:Pilot Projects D011788:Quality of Life D012107:Research Design D012648:Self Care D016896:Treatment Outcome D055815:Young Adult
Cancer survivors fatigue self-regulation model