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


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Judy Ho1,2, Antoinette Lee2, Duncan Macfarlane2, Daniel Fong2, Sharron Leung3, Ester Cerin2,4, Wynnie Chan2, Ivy Leung5, Sharon Lam2, Aliki Taylor6, Kar-keung Cheng6
1Queen Mary Hospital, Hong Kong, Hong Kong, 2The University of Hong Kong, Hong Kong, Hong Kong, 3Hong Kong Baptist Hospital, Hong Kong, Hong Kong, 4Deakin University, Victoria, Australia, 5Queen Elizabeth Hospital, Hong Kong, Hong Kong, 6The University of Birmingham, Birmingham, UK

Background

Colorectal cancer (CRC) 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/processed meat cause CRC whereas physical activity (PA) 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 PA level reduced CRC mortality.

Method

Based on the Theory of Planned Behaviour and the Health Action Process Approach, we aim to demonstrate the feasibility of two behavioural interventions intended to improve CRC outcome and which are designed to increase PA level and reduce consumption of a Western-pattern diet. This will be a three-year multicentre randomised controlled trial (RCT) in a 2x2 factorial design comparing the "Moving Bright, Eating Smart" 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.

Results

224 CRC patients from 4 hospitals after curative treatment without evidence of recurrence will be recruited. Primary outcome measure will be whether PA and dietary targets are met at the end of the intervention. Secondary outcome measures include magnitude and mechanism of behavioural change, degree and determinants of compliance, and additional health benefits and side effects of the intervention.

Conclusion

The results of this study will establish the feasibility of targeting diet and PA and demonstrate the magnitude of behaviour change. The information will facilitate the design of a further larger phase III RCT with CRC outcome (recurrence and mortality) as the study endpoints.

ClinicalTrials.gov No: NCT01708824