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 W C Ho, Antoinette M Lee, Duncan J Macfarlane, Daniel Y T Fong, Sharron Leung, Ester Cerin, Wynnie Y Y Chan, Ivy P F Leung, Sharon H S Lam, Aliki J Taylor, Kar-keung Cheng, Judy W C Ho, Antoinette M Lee, Duncan J Macfarlane, Daniel Y T Fong, Sharron Leung, Ester Cerin, Wynnie Y Y Chan, Ivy P F Leung, Sharon H S Lam, Aliki J Taylor, Kar-keung Cheng

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.

Figures

Figure 1
Figure 1
Participant flow chart.

References

    1. Colorectal cancer in Hong Kong. .
    1. Cancer incidence in five continents. Volumes I to IX. .
    1. Colorectal Cancer Report 2010 Summary. Food, nutrition, physical activity, and the prevention of colorectal cancer. World Cancer Research Fund/American Institute of Cancer Research, Continuous Update Project; 2010.
    1. WCRF/AICR. Food, nutrition, physical activity and the prevention of cancer. A global perspective. Washington DC: WCRF/AICR; 2007.
    1. Meyerhardt JA, Giovannucci EL, Holmes MD, Chan AT, Chan JA, Colditz GA, Fuchs CS. Physical activity and survival after colorectal cancer diagnosis. J Clin Oncol. 2006;24:3527–3534. doi: 10.1200/JCO.2006.06.0855.
    1. Meyerhardt JA, Heseltine D, Niedzwiecki D, Hollis D, Saltz LB, Mayer RJ, Thomas J, Nelson H, Whittom R, Hantel A. Impact of physical activity on cancer recurrence and survival in patients with stage III colon cancer: findings from CALGB 89803. J Clin Oncol. 2006;24:3535–3541. doi: 10.1200/JCO.2006.06.0863.
    1. Meyerhardt JA, Niedzwiecki D, Hollis D, Saltz LB, Hu FB, Mayer RJ, Nelson H, Whittom R, Hantel A, Thomas J, Fuchs CS. Association of dietary patterns with cancer recurrence and survival in patients with stage III colon cancer. JAMA. 2007;298:754–764. doi: 10.1001/jama.298.7.754.
    1. Fong DY, Ho JW, Hui BP, Lee AM, Macfarlane DJ, Leung SS, Cerin E, Chan WY, Leung IP, Lam SH. Physical activity for cancer survivors: meta-analysis of randomised controlled trials. BMJ. 2012;344:e70. doi: 10.1136/bmj.e70.
    1. Morimoto LM, Newcomb PA, White E, Bigler J, Potter JD. Insulin-like growth factor polymorphisms and colorectal cancer risk. Cancer Epidemiol Biomarkers Prev. 2005;14:1204–1211. doi: 10.1158/1055-9965.EPI-04-0695.
    1. Pinto BM, Papandonatos GD, Goldstein MG, Marcus BH, Farrell N. Home-based physical activity intervention for colorectal cancer survivors. Psychooncology. 2011;22:54–64.
    1. Anderson AS, Caswell S, Wells M, Steele RJ, Macaskill S. "It makes you feel so full of life" LiveWell, a feasibility study of a personalised lifestyle programme for colorectal cancer survivors. Support Care Cancer. 2010;18:409–415. doi: 10.1007/s00520-009-0677-4.
    1. Bourke L, Thompson G, Gibson DJ, Daley A, Crank H, Adam I, Shorthouse A, Saxton J. Pragmatic lifestyle intervention in patients recovering from colon cancer: a randomized controlled pilot study. Arch Phys Med Rehabil. 2011;92:749–755. doi: 10.1016/j.apmr.2010.12.020.
    1. Ajzen I. The theory of planned behaviour. Organiz Behav Huma Dec Proc. 1991;50:179–211. doi: 10.1016/0749-5978(91)90020-T.
    1. Courneya KS. Understanding readiness for regular physical activity in older individuals: an application of the theory of planned behavior. Health Psychol. 1995;14:80–87.
    1. Courneya KS, Bobick TM. Integrating the theory of planned behaviour with the processes and stages of change in the exercise domain. Psychol Sport Exercise. 2000;1:41–56. doi: 10.1016/S1469-0292(00)00006-6.
    1. Godin G, Gagne C, Maziade J, Moreault L, Beaulieu D, Morel S. Breast cancer: The intention to have a mammography and a clinic breast examination - Application of the theory of planned behaviour. Psychol Health. 2001;16:423–441. doi: 10.1080/08870440108405517.
    1. Godin G, Kok G. The theory of planned behaviour: A review of its applications to health-related behaviours. Am J Health Promot. 1996;11:87–98. doi: 10.4278/0890-1171-11.2.87.
    1. Godin G, Tinka BA, Sow A, Minani I, Morin D, Alary M. Correlates of condom use among sex workers and their boyfriends in three West African countries. AIDS Behav. 2008;12:441–451. doi: 10.1007/s10461-007-9296-6.
    1. Jones LW, Courneya KS, Fairey AS, Mackey JR. Effects of an oncologist’s recommendation to exercise on self-reported exercise behavior in newly diagnosed breast cancer survivors: A single-blind, randomized controlled trial. Ann Behav Med. 2004;28:105–113. doi: 10.1207/s15324796abm2802_5.
    1. Jones LW, Courneya KS, Fairey AS, Mackey JR. Does the theory of planned behavior mediate the effects of an oncologist’s recommendation to exercise in newly diagnosed breast cancer survivors? Results from a randomized controlled trial. Health Psychol. 2005;24:189–197.
    1. Webb TL, Sheeran P. Does changing behavioral intentions engender bahaviour change? A meta-analysis of the experimental evidence. Psychol Bull. 2006;132:249–268.
    1. Schwarzer R, Luszczynska A. How to overcome health-compromising behaviors - The health action process approach. Eur Psychol. 2008;13:141–151. doi: 10.1027/1016-9040.13.2.141.
    1. Bandura A. Social foundations of thought and action. NJ: Prentice Hall; 1986.
    1. Fishbein M, Ajzen I. Belief, attitude, intention and behaviour: An introduction to theory and research. Reading, MA: Addison-Wesley; 1975.
    1. Heckhausen H. Motivation and action. Berlin: Springer; 1991.
    1. Heckhausen H, Gollwitzer PM. Thought Contents and Cognitive-Functioning in Motivational Versus Volitional States of Mind. Motiv Emotion. 1987;11:101–120. doi: 10.1007/BF00992338.
    1. Schwarzer R. Modeling health behavior change: How to predict and modify the adoption and maintenance of health behaviors. Appl Psychol-Int Rev. 2008;57:1–29.
    1. Leventhal H, Rabin C, Leventhal EA, Burns E. Health risk behaviours and aging. 5. San Diego, CA: Academic; 2001.
    1. Meyerhardt JA. Beyond standard adjuvant therapy for colon cancer: role of nonstandard interventions. Semin Oncol. 2011;38:533–541. doi: 10.1053/j.seminoncol.2011.05.007.
    1. Shu XO, Yang G, Jin F, Liu D, Kushi L, Wen W, Gao YT, Zheng W. Validity and reproducibility of the food frequency questionnaire used in the Shanghai Women’s Health Study. Eur J Clin Nutr. 2004;58:17–23. doi: 10.1038/sj.ejcn.1601738.
    1. Bull FC, Maslin TS, Armstrong T. Global physical activity questionnaire (GPAQ): nine country reliability and validity study. J Phys Act Health. 2009;6:790–804.
    1. Ware J Jr, Kosinski M, Keller SD. A 12-Item Short-Form Health Survey: construction of scales and preliminary tests of reliability and validity. Med Care. 1996;34:220–233. doi: 10.1097/00005650-199603000-00003.
    1. Lam CL, Tse EY, Gandek B. Is the standard SF-12 health survey valid and equivalent for a Chinese population? Qual Life Res. 2005;14:539–547. doi: 10.1007/s11136-004-0704-3.
    1. Yu CL, Fielding R, Chan CL, Tse VK, Choi PH, Lau WH, Choy DT, O SK, Lee AW, Sham JS. Measuring quality of life of Chinese cancer patients: A validation of the Chinese version of the Functional Assessment of Cancer Therapy-General (FACT-G) scale. Cancer. 2000;88:1715–1727. doi: 10.1002/(SICI)1097-0142(20000401)88:7<1715::AID-CNCR28>;2-K.
    1. Zigmond AS, Snaith RP. The hospital anxiety and depression scale. Acta Psychiatr Scand. 1983;67:361–370. doi: 10.1111/j.1600-0447.1983.tb09716.x.
    1. Leung C, Ho S, Kao C, Hung C, Chen C. Evaluation of the Chinese version of the Hospital Anxiety and Depression Scale: a cross-cultural perspective. Int J Psychosom. 1992;40:29–34.
    1. Cohen S, Williamson G, editor. Perceived stress in a probability sample of the United States. CA: Sage; 1998.
    1. Courneya KS, Booth CM, Gill S, O’Brien P, Vardy J, Friedenreich CM, Au HJ, Brundage MD, Tu D, Dhillon H, Meyer RM. The Colon Health and Life-Long Exercise Change trial: a randomized trial of the National Cancer Institute of Canada Clinical Trials Group. Curr Oncol. 2008;15:279–285.
    1. Meyerhardt JA, Giovannucci EL, Ogino S, Kirkner GJ, Chan AT, Willett W, Fuchs CS. Physical activity and male colorectal cancer survival. Arch Intern Med. 2009;169:2102–2108. doi: 10.1001/archinternmed.2009.412.
    1. Samitz G, Egger M, Zwahlen M. Domains of physical activity and all-cause mortality: systematic review and dose–response meta-analysis of cohort studies. Int J Epidemiol. 2011;40:1382–1400. doi: 10.1093/ije/dyr112.
    1. Ahmed HM, Blaha MJ, Nasir K, Rivera JJ, Blumenthal RS. Effects of physical activity on cardiovascular disease. Am J Cardiol. 2012;109:288–295. doi: 10.1016/j.amjcard.2011.08.042.
    1. Haskell WL, Lee IM, Pate RR, Powell KE, Blair SN, Franklin BA, Macera CA, Heath GW, Thompson PD, Bauman A. Physical activity and public health: updated recommendation for adults from the American College of Sports Medicine and the American Heart Association. Circulation. 2007;116:1081–1093.
    1. Lynch BM, Cerin E, Owen N, Hawkes AL, Aitken JF. Prospective relationships of physical activity with quality of life among colorectal cancer survivors. J Clin Oncol. 2008;26:4480–4487. doi: 10.1200/JCO.2007.15.7917.
    1. Giovannucci E. Insulin and colon cancer. Cancer Causes Control. 1995;6:164–179. doi: 10.1007/BF00052777.
    1. Giovannucci E. Insulin, insulin-like growth factors and colon cancer: a review of the evidence. J Nutr. 2001;131:3109S–3120S.
    1. Kaaks R, Lukanova A. Energy balance and cancer: the role of insulin and insulin-like growth factor-I. Proc Nutr Soc. 2001;60:91–106. doi: 10.1079/PNS200070.
    1. Schoen RE, Tangen CM, Kuller LH, Burke GL, Cushman M, Tracy RP, Dobs A, Savage PJ. Increased blood glucose and insulin, body size, and incident colorectal cancer. J Natl Cancer Inst. 1999;91:1147–1154. doi: 10.1093/jnci/91.13.1147.
    1. Kaaks R, Toniolo P, Akhmedkhanov A, Lukanova A, Biessy C, Dechaud H, Rinaldi S, Zeleniuch-Jacquotte A, Shore RE, Riboli E. Serum C-peptide, insulin-like growth factor (IGF)-I, IGF-binding proteins, and colorectal cancer risk in women. J Natl Cancer Inst. 2000;92:1592–1600. doi: 10.1093/jnci/92.19.1592.
    1. Palmqvist R, Stattin P, Rinaldi S, Biessy C, Stenling R, Riboli E, Hallmans G, Kaaks R. Plasma insulin, IGF-binding proteins-1 and −2 and risk of colorectal cancer: a prospective study in northern Sweden. Int J Cancer. 2003;107:89–93. doi: 10.1002/ijc.11362.
    1. Campbell NC, Murray E, Darbyshire J, Emery J, Farmer A, Griffiths F, Guthrie B, Lester H, Wilson P, Kinmonth AL. Designing and evaluating complex interventions to improve health care. BMJ. 2007;334:455–459. doi: 10.1136/.

Source: PubMed

Szponzorok és közreműködők

Egészségi állapot

Kábítószer-beavatkozások

3
Iratkozz fel