Healthy Eating and Active Lifestyle After Bowel Cancer (HEAL ABC): feasibility randomised controlled trial protocol

Abstract

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

Healthy eating and active lifestyle after bowel cancer: feasibility of a randomised controlled trial

“…This chapter describes the methods used in the feasibility study. The study protocol for this PhD was published (Sremanakova et al, 2020).…”

“…The study was successfully completed, and minimal changes due to Covid19 were introduced compared to the published protocol (Sremanakova et al, 2020). The study was deemed feasible based on criteria for methodological issues that could arise during the conduct of the study (Shanyinde et al, 2011) and the intervention was delivered as intended based on the fidelity assessment criteria (Bellg et al, 2004).…”

Healthy Eating and Active Lifestyle after Bowel Cancer (HEAL ABC) – Feasibility Randomised Controlled Trial

“…The study was approved by the North West Greater Manchester South Research Ethics Committee (IRAS ID 273818), and registered on the National Institute of Health Clinical Trials register (NCT04227353). Trial protocol was published (25). The COVID-19 global pandemic resulted in some deviations from the original study protocol.…”