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Pragmatic lifestyle intervention in patients recovering from colon cancer: a randomized controlled pilot study
Bourke L, Thompson G, Gibson DJ, Daley A, Crank H, Adam I, Shorthouse A, Saxton J
Archives of Physical Medicine and Rehabilitation 2011 May;92(5):749-755
clinical trial
8/10 [Eligibility criteria: Yes; Random allocation: Yes; Concealed allocation: Yes; Baseline comparability: Yes; Blind subjects: No; Blind therapists: No; Blind assessors: Yes; Adequate follow-up: Yes; Intention-to-treat analysis: Yes; Between-group comparisons: Yes; Point estimates and variability: Yes. Note: Eligibility criteria item does not contribute to total score] *This score has been confirmed*

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 69 y; range 52 to 80 y), Dukes stage A to C. INTERVENTIONS: Participants were randomized 6 to 24 months postoperatively to either a 12-week program of combined exercise and dietary advice or standard treatment. MAIN OUTCOME MEASURES: Exercise and dietary behavior, fatigue, health-related quality of life (QOL), aerobic exercise tolerance, functional capacity, muscle strength, and anthropometery were assessed 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 = 0.068), fatigue (p = 0.005), aerobic exercise tolerance (p = 0.010), chair sit-to-stand performance (p = 0.003), and waist-to-hip ratio (p = 0.002). A positive change in dietary fiber intake (p = 0.044) was also observed in the intervention group. No change in QOL was observed (p = 0.795). CONCLUSIONS: These preliminary results suggest that a pragmatic 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 exercise tolerance, functional capacity, and waist-to-hip ratio. These findings need to be confirmed with a larger-scale definitive randomized controlled trial.

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