ORIGINAL ARTICLE Pragmatic Lifestyle Intervention in Patients Recovering From Colon Cancer: A Randomized Controlled Pilot Study Liam Bourke, PhD, Georgia Thompson, BA, Debra J. Gibson, MSc, Amanda Daley, PhD, Helen Crank, PhD, Ian Adam, MBBS, FRCS, Andrew Shorthouse, MS, FRCS, John Saxton, PhD ABSTRACT. 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;92:749-55. Objective: To investigate the feasibility of a pragmatic lifestyle intervention in patients who had recently completed surgery and chemotherapy for colon cancer and to obtain preliminary data of its impact on important health outcomes. Design: A prospective, randomized, controlled pilot trial. Setting: University rehabilitation facility. Participants: Eighteen (N=18) colon cancer survivors (mean age=69y; range, 52– 80y), Dukes stage A to C. Interventions: Participants were randomized 6 to 24 months postoperatively to either a 12-week program of combined ex- ercise and dietary advice or standard treatment. Main Outcome Measures: Exercise and dietary behavior, fa- tigue, health-related quality of life (QOL), aerobic exercise tolerance, functional capacity, muscle strength, and anthropometery were as- sessed at baseline and immediately after the intervention. Results: Adherences to supervised and independent exercise during the intervention were 90% and 94%, respectively, and there was low attrition (6%). The lifestyle intervention elicited improvements in exercise behavior (P=.068), fatigue (P=.005), aerobic exercise tolerance (P=.010), chair sit-to-stand perfor- mance (P=.003), and waist-to-hip ratio (P=.002). A positive change in dietary fiber intake (P=.044) was also observed in the intervention group. No change in QOL was observed (P=.795). Conclusions: These preliminary results suggest that a prag- matic lifestyle intervention implemented 6 to 24 months after primary treatment for colon cancer was feasible. We observed a significant impact on dietary behavior, fatigue, aerobic exer- cise tolerance, functional capacity, and waist-to-hip ratio. These findings need to be confirmed with a larger-scale defin- itive randomized controlled trial. Key Words: Colonic neoplasms; Diet; Exercise; Fatigue; Rehabilitation. © 2011 by the American Congress of Rehabilitation Medicine C OLORECTAL CANCER IS the third most common can- cer in the United Kingdom, with 37,500 cases diagnosed each year. Approximately one third of cases are located in the rectum and the remainder in the colon. 1 Despite improvements in CRC survival, the side effects of treatment (surgery and/or chemotherapy) include pain, reduced functional capacity, re- duced tolerance to exercise, anxiety, and depression. 2 In addi- tion, postoperative fatigue is a major problem and can prevent the return to normal activity and function. 3 Limited evidence supports the efficacy of home-based and hospital-based exercise interventions for improving health- related QOL and postoperative fatigue in CRC survivors. 4,5 Furthermore, although 2 recent pilot studies provided pre- liminary evidence of improved health-related QOL and di- etary behavior after lifestyle interventions (combined exer- cise and dietary advice), 6,7 both studies were single group designs (excluding a control arm) and failed to show any increase in aerobic fitness/tolerance or functional capacity. Taking these limitations into account and considering recent observational evidence of associations between physical ac- tivity, westernized dietary habits, and mortality in CRC survivors, 8,9 further studies aimed at investigating the im- pact of lifestyle interventions on important health outcomes are clearly warranted. Hence, the aim of this pilot study was to investigate the feasibility of a pragmatic lifestyle intervention (aimed at increasing exercise participation and improving dietary be- havior) in colon cancer survivors in terms of recruitment rate, acceptability of the intervention, and attrition, with the data used to inform a sample size calculation for a larger trial. Secondarily, we aimed to obtain preliminary data on the impact of the intervention on exercise and dietary be- havior, fatigue, health-related QOL, aerobic exercise toler- ance, functional capacity, muscle strength, and anthropom- etery by comparison with patients randomized to a standard care control group. From the eNIHR Cardiovascular Biomedical Research Unit, Sheffield Foundation Trust National Health Service Trust, Sheffield (Bourke); Faculty of Health and Wellbeing, Sheffield Hallam University, Collegiate Crescent Campus, Sheffield (Bourke, Gibson, Crank, Shorthouse); Department of Colorectal Surgery, Sheffield Teaching Hospitals National Health Service Foundation Trust, Northern General Hospital, Sheffield (Thompson, Adam, Shorthouse); Primary Care Clinical Sciences, College of Medical and Dental Sciences, University of Birmingham, Birmingham (Daley); and School of Allied Health Professions, University of East Anglia, Norwich (Saxton), United Kingdom. Supported by Sheffield Hallam University. No commercial party having a direct financial interest in the results of the research supporting this article has or will confer a benefit on the authors or on any organi- zation with which the authors are associated. Correspondence to John Saxton, PhD, School of Allied Health Professions, Uni- versity of East Anglia, Norwich, NR4 7TJ, United Kingdom, e-mail: john. saxton@uea.ac.uk. Reprints are not available from the author. 0003-9993/11/9205-00980$36.00/0 doi:10.1016/j.apmr.2010.12.020 List of Abbreviations CRC colorectal cancer FACT-C Functional Assessment of Cancer Therapy— Colorectal FACT-F Functional Assessment of Cancer Therapy— Fatigue MDT multidisciplinary team MVT maximum voluntary torque QOL quality of life RCT randomized controlled trial RPE ratings of perceived exertion RMS root mean square sEMG surface electromyography delta sEMG change in rectified surface electromyography amplitude 749 Arch Phys Med Rehabil Vol 92, May 2011