Stephen Caswell

“It makes you feel so full of life” LiveWell, a feasibility study of a personalised lifestyle programme for colorectal cancer survivors

GoalsThe acceptability and feasibility of a 3-month personalised lifestyle (diet, exercise and weight management) intervention in overweight adults who had completed curative treatment for colorectal cancer were assessed by qualitative interviews, quality-of-life questionnaires and subjective and objective measures of diet and activity.Main resultsOver a 4-month period, 28 of 37 (75%) patients met the inclusion criteria and 20 (71%) of the eligible patients agreed to participate in the study and 18 (90%) completed the 3-month study. Reported adherence related to tailored advice, personalised feedback and family support. Reported barriers included time following surgery, fatigue, having a stoma or chronic diarrhoea and conflicting advice from clinicians. A weight change of −1.2 (±4.4) kg was achieved overall and −4.1 (±3.7) kg in the ten who had lost weight.ConclusionsColorectal cancer survivors will participate in a lifestyle change initiative. Interventions should be personalised to suit abilities, provide feedback on personal goals and encourage social support. Intervention timing and attaining greater support from clinicians should be explored prior to the development of an efficacy trial.

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

BackgroundColorectal 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/DesignThis 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.DiscussionThe 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

Understanding the potential and challenges of adenoma treatment as a prevention opportunity: insights from the BeWEL formative study

Objectives To explore prevention opportunities presented by colorectal adenoma diagnosis and inform engagement strategies for the BeWEL study (body weight and physical activity lifestyle intervention for colorectal cancer screening participants who have undergone adenoma removal). Methods Qualitative study comprising 4 purposively sampled focus groups conducted in urban and rural areas in Tayside, Scotland, with different deprivation levels. Participants were men and women (n = 17) aged 50-74 with BMI > 25 kg/m2 with removal of adenoma detected by colorectal cancer screening. Results Adenoma diagnosis presents both opportunities and challenges for prevention. Some patients perceived adenoma as minor and not sufficiently motivating to act as a ‘teachable moment’. Patients had low awareness of the relationship between adenoma and lifestyle factors, and received little information on prevention during screening and treatment. Consequently they interpreted post-treatment ‘all clear’ messages as validation of existing lifestyles, and did not see the relevance of prevention advice. Receptiveness increased when the association between lifestyle, adenoma recurrence and other illness was explained. Conclusion The study illustrates the value of exploratory research into patient understanding to improve communications and health services. Without unduly worrying patients, professionals should explain how to reduce risk of adenoma, cancer and other diseases, particularly through diet, physical activity and weight reduction.

Bowel health to better health: a minimal contact lifestyle intervention for people at increased risk of colorectal cancer.

Colorectal cancer screening forms part of Scotlands cancer reduction strategy. Screened participants, who had undergone colonoscopy and had adenoma(s) removed, were invited to participate in the bowel health to better health (BHBH) programme. BHBH tested the hypothesis that a minimal contact lifestyle intervention could prove effective in promoting changes in diet and activity. Baseline and follow-up questionnaires on lifestyle and psycho-social measures were undertaken in adults randomised to BHBH or a comparison group (CG). The 3-month intervention comprised personalised lifestyle advice, goal-setting and social support to promote increases in physical activity, fibre, fruit and vegetables. Response rate to BHBH was 51 %. BHBH participants (n 32) increased their intake of fibre (DINE FFQ scores 30 (sd 11)-41 (sd 13)) significantly (P < 0.001) more than the CG (n 30; 31 (sd 8)-30 (sd 11). No significant differences between the groups were detected for changes in fruits, vegetables and moderate activity. At baseline, only one participant from each study arm, met the target recommendations for fibre, fruit and vegetable intakes and physical activity. At follow up a significant number of BHBH participants, 15 (47 %) compared to 4 (13 %) of the CG were achieving all three lifestyle recommendations (chi2 (1, n 62) = 8.196, P = 0.006). If sustained, the positive behaviour change achieved through this intervention has the potential to impact on the progression of chronic disease risk including CVD.

Meeting the challenges of recruitment to multicentre, community-based, lifestyle-change trials: a case study of the BeWEL trial

BackgroundRecruiting participants to multicentre, community-based trials is a challenge. This case study describes how this challenge was met for the BeWEL trial, which evaluated the impact of a diet and physical activity intervention on body weight in people who had had pre-cancerous bowel polyps.MethodsThe BeWEL trial was a community-based trial, involving centres linked to the Scottish National Health Service (NHS) colorectal cancer screening programme. BeWEL had a recruitment target of 316 and its primary recruitment route was the colonoscopy clinics of the Scottish Bowel Screening Programme.ResultsBeWEL exceeded its recruitment target but needed a 6-month no-cost extension from the funder to achieve this. The major causes of delay were lower consent rates (49% as opposed to 70% estimated from earlier work), the time taken for NHS research and development department approvals and the inclusion of two additional sites to increase recruitment, for which there were substantial bureaucratic delays. A range of specific interventions to increase recruitment, for example, telephone reminders and a shorter participant information leaflet, helped to increase the proportion of eligible individuals consenting and being randomized.ConclusionsRecruitment to multicentre trials is a challenge but can be successfully achieved with a committed team. In a UK context, NHS research and development approval can be a substantial source of delay. Investigators should be cautious when estimating consent rates. If consent rates are less than expected, qualitative analysis might be beneficial, to try and identify the reason. Finally, investigators should select trial sites on the basis of a formal assessment of a site’s past performance and the likelihood of success in the trial being planned.Trial registrationCurrent Controlled Trials ISRCTN53033856

Diet and physical activity in patients with colorectal adenomas: directions for intervention programmes.

BACKGROUND Screening programmes provide an opportunity to combine early detection programmes with prevention strategies for chronic disease risk reduction. The aim of the current exploratory research was to identify diet and activity habits in adults diagnosed with colorectal adenomas on screening colonoscopy in order to inform the development of an intervention study in this patient group. METHODS Participants were recruited from colonoscopy clinics and completed a 7-day food diary and physical activity record. RESULTS Valid food diaries were completed by 32 participants. Mean daily intake of nonstarch polysaccharide was estimated at 14.2 (SD 4.2) g per day and fruit and vegetable intake (FVI) at 3.6 (SD 1.9) portions. The highest quartile of FVI consumers reported greater consumption of fruit (on any occasion) and vegetables (at evening meal) compared with low FVI consumers. Physical activity records (n = 36) indicated that walking was the most common method of activity with few indications of leisure time sport. Overall, 37% of participants failed to meet minimum recommend activity levels. CONCLUSION The magnitudes of change in activity and diet required to conform with current guidelines were estimated. Food habits that were pertinent to the population were identified and help to provide goal-based guidance for intervention design.

Awareness of Lifestyle and Colorectal Cancer Risk: Findings from the BeWEL Study.

It is estimated that 47% of colorectal cancers (CRC) could be prevented by appropriate lifestyles. This study aimed to identify awareness of the causes of CRC in patients who had been diagnosed with a colorectal adenoma through the Scottish Bowel Screening Programme and subsequently enrolled in an intervention trial (using diet and physical activity education and behavioural change techniques) (BeWEL). At baseline and 12-month follow-up, participants answered an open-ended question on factors influencing CRC development. Of the 329 participants at baseline, 40 (12%) reported that they did not know any risk factors and 36 (11%) failed to identify specific factors related to diet and activity. From a potential knowledge score of 1 to 6, the mean score was 1.5 (SD 1.1, range 0 to 5) with no difference between intervention and control groups. At follow-up, the intervention group had a significantly greater knowledge score and better weight loss, diet, and physical activity measures than the control group. Awareness of relevant lifestyle factors for CRC remains low in people at increased risk of the disease. Opportunities within routine NHS screening to aid the capability (including knowledge of risk factors) of individuals to make behavioural changes to reduce CRC risk deserve exploration.

Detailed protocol for the lifestyle intervention in the BeWEL randomised controlled trial of weight loss in adults who have had a colorectal adenoma

Introduction The BeWEL study is aimed at assessing the impact of a personalised lifestyle programme on body weight in people at risk of developing colorectal adenomas. The study is a two-arm multicentre randomised controlled trial comparing the BeWEL lifestyle programme against usual care. Over 12 months, 316 people who have had a colorectal adenoma removed through the national screening programme will be randomised to provide 80% power to detect a weight loss (primary outcome) of 7% over 12 months. Methods The 12-month intervention will be delivered by lifestyle counsellors via three face-to-face visits followed by nine monthly telephone support calls. Consultant endorsement for the study will be stressed. An individualised caloric prescription based on estimates for weight maintenance −600 kcal will be calculated. Motivational interviewing techniques will be used to identify personal motivations for weight change and ways to improve perceived self-efficacy. The programme will utilise personalised diet and physical activity data from baseline measures to set behavioural goals. A range of behavioural strategies will be employed to support lifestyle change including goal setting, identifying specific implementation intentions, self-monitoring and feedback. Emphasis will be placed on self-monitoring body weight, and weighing scales will be provided. Programme acceptability will be explored postintervention with indepth interviews. Compliance and impact will be assessed by baseline and follow-up measures of diet by self-report, activity by accelerometry and anthropometry. Ethics and dissemination Ethical approval has been obtained from the Tayside Committee on Medical Research Ethics. Dissemination of results will focus on publications in peer-reviewed journals, presentations at national/international cancer meetings and NHS groups. In addition, the work will be communicated to the public through forums such at The Scottish Cancer Prevention Network (http://www.cancerpreventionscotland.co.uk/). The trial is registered with Current Controlled Trials (International Standard Randomised Controlled Trials No: ISRCTN53033856).

Colorectal adenomas and diabetes: implications for disease prevention.

This study assessed the baseline type II diabetes mellitus (T2DM) risk status among overweight patients with screen‐detected colorectal adenomas and explored the implications of the findings for preventative practice.