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Open Access Study protocol

Study protocol for “Moving Bright, Eating Smart”– A phase 2 clinical trial on the acceptability and feasibility of a diet and physical activity intervention to prevent recurrence in colorectal cancer survivors

Judy WC Ho1*, Antoinette M Lee2, Duncan J Macfarlane3, Daniel YT Fong4, Sharron Leung5, Ester Cerin36, Wynnie YY Chan7, Ivy PF Leung8, Sharon HS Lam1, Aliki J Taylor9 and Kar-keung Cheng9

Author Affiliations

1 Division of Colorectal Surgery, Department of Surgery, Li Ka Shing Faculty of Medicine, The University of Hong Kong, Pokfulam, Hong Kong

2 Department of Psychiatry, Li Ka Shing Faculty of Medicine, The University of Hong Kong, Pokfulam, Hong Kong

3 Institute of Human Performance, The University of Hong Kong, Pokfulam, Hong Kong

4 School of Nursing, Li Ka Shing Faculty of Medicine, The University of Hong Kong, Pokfulam, Hong Kong

5 School of Nursing, Hong Kong Baptist Hospital, 6/F, C-Bons International Building 108 Wai Yip Street, Kwun Tong, Kowloon, Hong Kong

6 School of Exercise and Nutrition Sciences, Faculty of Health, Deakin University, 221 Burwood Highway, Burwood, VIC, Australia

7 School of Professional and Continuing Education, The University of Hong Kong, Pokfulam, Hong Kong

8 Department of Dietetics, Queen Elizabeth Hospital, Gascoigne Road, Kowloon, Hong Kong

9 Department of Public Health, Epidemiology and Biostatistics, University of Birmingham, Public Health Building, Edgbaston, Birmingham B15 2TT, UK

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BMC Public Health 2013, 13:487  doi:10.1186/1471-2458-13-487

Published: 20 May 2013

Abstract

Background

Colorectal cancer is the second most common cancer and cancer-killer in Hong Kong with an alarming increasing incidence in recent years. The latest World Cancer Research Fund report concluded that foods low in fibre, and high in red and processed meat cause colorectal cancer whereas physical activity protects against colon cancer. Yet, the influence of these lifestyle factors on cancer outcome is largely unknown even though cancer survivors are eager for lifestyle modifications. Observational studies suggested that low intake of a Western-pattern diet and high physical activity level reduced colorectal cancer mortality. The Theory of Planned Behaviour and the Health Action Process Approach have guided the design of intervention models targeting a wide range of health-related behaviours.

Methods/design

We aim to demonstrate the feasibility of two behavioural interventions intended to improve colorectal cancer outcome and which are designed to increase physical activity level and reduce consumption of a Western-pattern diet. This three year study will be a multicentre, randomised controlled trial in a 2x2 factorial design comparing the “Moving Bright, Eating Smart” (physical activity and diet) programme against usual care. Subjects will be recruited over a 12-month period, undertake intervention for 12 months and followed up for a further 12 months. Baseline, interim and three post-intervention assessments will be conducted.

Two hundred and twenty-two colorectal cancer patients who completed curative treatment without evidence of recurrence will be recruited into the study. Primary outcome measure will be whether physical activity and dietary targets are met at the end of the 12-month intervention. Secondary outcome measures include the magnitude and mechanism of behavioural change, the degree and determinants of compliance, and the additional health benefits and side effects of the intervention.

Discussion

The results of this study will establish the feasibility of targeting the two behaviours (diet and physical activity) and demonstrate the magnitude of behaviour change. The information will facilitate the design of a further larger phase III randomised controlled trial with colorectal cancer outcome as the study endpoint to determine whether this intervention model would reduce colorectal cancer recurrence and mortality.

Trial registration

ClinicalTrials.gov No: NCT01708824

Keywords:
Colorectal cancer; Cancer survivor; Diet; Meat; Grains; Physical activity; Behavioural intervention; Feasibility; Acceptability; Randomised