Study design: Non-randomised feasibility trial
Setting: NHS Tayside
Participants: Adults with stage I - III colorectal cancer
Intervention: The programme targeted smoking, alcohol, physical activity, diet and weight management. It was delivered in 3 face-to-face counselling sessions (plus 9 phone calls) by lifestyle coaches over three phases (1 - pre-surgery, 2 - surgical recovery and 3 - post treatment recovery).
Primary outcome: Feasibility measures (recruitment, retention, programme implementation, achieved measures, fidelity, factors affecting protocol adherence and acceptability).
Secondary outcomes: Measured changes in body weight, waist circumference, walking and self –reported physical activity, diet, smoking and alcohol intake, fatigue, bowel function and Quality of Life (QoL).
Results: Of 84 patients diagnosed, 22 (26%) were recruited and 15 (18%) completed the study. Median time for intervention delivery was 5.5 hours. Coaches reported covering most (>70%) of the intervention components but had difficulties during phase 2. Evaluation measures (except walk test) were achieved by all participants at baseline, and most (<90%) at end of phase 2 and phase 3, but <20% at end of phase 1. Protocol challenges included limited time between diagnosis and surgery and the presence of co-morbidities. The intervention was rated highly by participants but limited support from NHS staff was noted. The majority of participants (77%) had a BMI >25kg/m2 and none were underweight. Physical activity data showed a positive trend towards increased activity overall but no other changes in secondary outcomes were detected.
Conclusions: To make this intervention feasible for testing as a full trial, further research is required on a) recruitment optimisation b) appropriate assessment tools c) protocols for phase 2 and 3 which can build in flexibility and d) ways for NHS staff to facilitate the program.
- colorectal cancer
- lifestyle intervention