Feasibility study to assess the delivery of a lifestyle intervention (TreatWELL) for patients with colorectal cancer undergoing potentially curative treatment.

OBJECTIVES: To assess the feasibility of delivering and evaluating a lifestyle programme for patients with colorectal cancer undergoing potentially curative treatments. STUDY DESIGN: Non-randomised feasibility trial. SETTING: National Health Service (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 three face-to-face counselling sessions (plus nine phone calls) by lifestyle coaches over three phases (1: presurgery, 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, alcohol intake, fatigue, bowel function and quality of life. 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 comorbidities. The intervention was rated highly by participants but limited support from NHS staff was noted. The majority of participants (77%) had a body mass index>25 kg/m2 and none was 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 programme. TRIAL REGISTRATION NUMBER: ISRCTN52345929; Post-results.

The impact of a bodyweight and physical activity intervention (BeWEL) initiated through a national colorectal cancer screening programme: randomised controlled trial.

OBJECTIVE: To evaluate the impact of a diet and physical activity intervention (BeWEL) on weight change in people with a body mass index >25 weight (kg)/height (m)(2) at increased risk of colorectal cancer and other obesity related comorbidities. DESIGN: Multicentre, parallel group, randomised controlled trial. SETTING: Four Scottish National Health Service health boards. PARTICIPANTS: 329 overweight or obese adults (aged 50 to 74 years) who had undergone colonoscopy after a positive faecal occult blood test result, as part of the national bowel screening programme, and had a diagnosis of adenoma confirmed by histopathology. 163 were randomised to intervention and 166 to control. INTERVENTION: Participants were randomised to a control group (weight loss booklet only) or 12 month intervention group (three face to face visits with a lifestyle counsellor plus monthly 15 minute telephone calls). A goal of 7% reduction in body weight was set and participants received a personalised energy prescription (2508 kJ (600 kcal) below that required for weight maintenance) and bodyweight scales. Motivational interviewing techniques explored self assessed confidence, ambivalence, and personal values concerning weight. Behavioural strategies included goal setting, identifying intentions of implementation, self monitoring of body weight, and counsellor feedback about reported diet, physical activity, and weight change. MAIN OUTCOME MEASURES: The primary outcome was weight change over 12 months. Secondary outcomes included changes in waist circumference, blood pressure, fasting cardiovascular biomarkers, and glucose metabolism variables, physical activity, diet, and alcohol consumption. RESULTS: At 12 months, data on the primary outcome were available for 148 (91%) participants in the intervention group and 157 (95%) in the control group. Mean weight loss was 3.50 kg (SD 4.91) (95% confidence interval 2.70 to 4.30) in the intervention group compared with 0.78 kg (SD 3.77) (0.19 to 1.38) in the control group. The group difference was 2.69 kg (95% confidence interval 1.70 to 3.67). Differences between groups were significant for waist circumference, body mass index, blood pressure, blood glucose level, diet, and physical activity. No reported adverse events were considered to be related to trial participation. CONCLUSIONS: Significant weight loss can be achieved by a diet and physical activity intervention initiated within a national colorectal cancer screening programme, offering considerable potential for risk reduction of disease in older adults. TRIAL REGISTRATION: Current Controlled Trials ISRCTN53033856.

Study protocol for BeWEL: the impact of a BodyWEight and physicaL activity intervention on adults at risk of developing colorectal adenomas.

BACKGROUND: Colorectal cancer (CRC) is the third most commonly diagnosed cancer and the second highest cause of cancer death in the UK. Most cases occur in people over 50 years and CRC often co-exists with other lifestyle related disorders including obesity, type 2 diabetes mellitus (T2DM) and cardiovascular disease (CVD). These diseases share risk factors related to the metabolic syndrome including large body size, abnormal lipids and markers of insulin resistance indicating common aetiological pathways. METHODS/DESIGN: This 3 year study will be a two-arm, multicentre, randomised controlled trial comparing the BeWEL lifestyle (diet, physical activity and behaviour change) programme against usual care. The pre-trial development will take 6 months and participants will be recruited over a 12 month period and undertake the intervention and follow up for 12 months (total 24 months recruitment and intervention implementation) with a further 6 months for data collection, analysis and interpretation.Four hundred and fifty two participants who have had a colorectal adenoma detected and removed (through the national colorectal screening programme) will provide 80% power to detect a weight loss of 7% over 12 months.Primary outcomes are changes in body weight and waist circumference. Secondary outcomes will include cardiovascular risk factors, psycho-social measures and intervention costs. DISCUSSION: The results from this study will enhance the evidence base for lifestyle change in patients at higher risk of chronic disease including obesity related cancers.International Standard Randomised Controlled Trials No: ISRCTN53033856.