Healthy Eating and Active Lifestyle After Bowel Cancer (HEAL ABC): feasibility randomised controlled trial protocol
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(2020) 6:176
STUDY PROTOCOL
Open Access
Healthy Eating and Active Lifestyle After Bowel Cancer (HEAL ABC): feasibility randomised controlled trial protocol Jana Sremanakova1,2* , Anne Marie Sowerbutts1,2, Chris Todd1,2,3,4, Richard Cooke5 and Sorrel Burden1,2,4,6
Abstract Background: Targeting modifiable lifestyle factors including diet and physical activity represents a potentially costeffective 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 Keywords: Colorectal, Cancer, Diet, Physical activity, Behaviour change, Survivorship
Background Over recent decades, the number of people living with and beyond cancer has continued to rise worldwide. Current survival rates are associated with increased cancer incidence reaching 18 million new cases in 2018 [1], * Correspondence: [email protected] 1 School of Health Sciences, University of Manchester, Oxford Road, Manchester M13 9PL, UK 2 Manchester Academic Health Science Centre, Manchester, UK Full list of author information is available at the end of the article
ageing of the population [2] and advances in early cancer detection and treatment [3]. Several definitions of cancer survivorship have been proposed. One approach in research and within the medical community d
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