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Healthy Eating and Active Lifestyle After Bowel Cancer (HEAL ABC): feasibility randomised controlled trial protocol
Jana Sremanakova1,2, Anne Marie Sowerbutts3,4, Chris Todd3,4,5,6
1School of Health Sciences, University of Manchester, Oxford Road, Manchester, M13 9PL, UK. jana.sremanakova@manchester.ac.uk.
Background:
Targeting modifiable lifestyle factors including diet and physical activity represents a potentially cost-effective strategy that could support a growing population of colorectal cancer survivors and improve their health outcomes. Currently, effective, evidence-based interventions and resources helping people after bowel cancer to adopt new lifestyle habits are lacking. The aim of this trial is to test the Healthy Eating and Active Lifestyle After Bowel Cancer (HEAL-ABC) intervention to inform a future definitive randomised controlled trial.
Methods/Design:
This is a feasibility randomised controlled trial. A total of 72 survivors who have completed surgery and all anticancer treatments will be recruited. The intervention group will receive HEAL-ABC resources based on behaviour change theory combined with supportive telephone calls informed by motivational interviewing every 2 weeks during the 3-month intervention, and once a month for 6 months to follow-up. Participants in the control group will follow usual care and have access to resources available in the public domain. The study is testing feasibility of the intervention including adherence and ability to collect data on anthropometry, body composition, diet, physical activity, behaviour change, quality of life, blood markers, contact with healthcare services, morbidities and overall survival.
Discussion:
The proposed study will add to the evidence base by addressing an area where there is a paucity of data. This study on lifestyle interventions for people after colorectal cancer follows the Medical Research Council guidance on evaluating complex interventions in clinical practice. It focuses on people living after treatment for colorectal cancer and targets an important research area identified by cancer survivors as a research priority reported by the National Cancer Institute and James Lind Alliance UK.
Trial Registration:
ClinicalTrials.gov NCT04227353 approved on the 13th of January 2020.
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