1. The BeWEL study - implications for raising awareness of cancer prevention messages in the cancer screening setting Dr Angela Craigie Centre for Public Health Nutrition Research Centre for Research into Cancer Prevention and Screening University of Dundee

2. Overview Background rationale BeWEL RCT Study design Development work and challenges

3. Summary Statistics for Colorectal Cancer (CRC) in Scotland ScotlandMalesFemales Rank Mortality 3 3 Percentage frequency of all cancers 15.0% 11.6% Number of new cases diagnosed in 2009 2135 1781 Number of deaths recorded in 2009782719 Change in incidence from 1994 to 2004 - 1.4% -1.0% Change in mortality from 1999 to 2009 -20.7% -12.3% ISD Scotland, 2011

4. Development of Colorectal Cancer FAP - Familial adenomatous polyposis HNPCC - Hereditary non- polyposis colorectal cancer For the majority CRC is an example of a genetic / environmental interaction

5. Modifiable risk factors for CRC Decreases RiskIncreases Risk CONVINCINGPhysical activityRed meat Processed meat Alcoholic drinks (men) Body fatness Abdominal fatness PROBABLE Garlic Milk Calcium Alcoholic drinks (women) Foods containing dietary fibre  WCRF / AICR (2007) Food, nutrition, physical activity and the prevention of cancer: a global perspective  WCRF / AICR (2011) Continuous update project.

6. WCRF / AICR (2007) Food, nutrition, physical activity and the prevention of cancer: a global perspective

7. FOBT Screening for Colorectal Cancer

8. Positive FOBT = Colonoscopy Removing the adenoma removes the immediate risk of disease The underlying factors which might influence the development of adenoma remain Emmons et al (2005) argue that failure to explain the relationship between lifestyle factors and colorectal cancer may leave patients thinking surveillance is the only strategy for prevention Emmons KM et al (2005) Cancer Epidemiol Biomarkers Prev.14(6):1453-59.

9. Colorectal Cancer Screening : “A Window of Opportunity” Screening awakens curiosity about disease and its causes 1 : a 'Teachable Moment‘ 2 Encourages a culture of prevention and early detection Provides an opportunity to bring prevention to screening 1. Bankhead et al (2003) The impact of screening on future health-promoting behaviours and health beliefs: a systematic review. HTA 7 (42). 2. McBride CM et al. (2003) Health Educ Res, 18(2): 156-170.

10. Colorectal cancer screening as a teachable moment? +ve FOBt a time of raised anxiety Adenoma – pre-curser to cancer

11. Aim To investigate the impact of a Body WEight and PhysicaL activity intervention in healthy overweight individuals who have had colorectal adenomas (benign) removed on: Body weight (target 7% reduction) Waist circumference Cardiovascular risk factors Dietary intake and physical activity Self assessed general health Self-efficacy Programme acceptability to participants and staff Intervention cost

12. Study design Two-arm multi-centre RCT Hospital setting: NHS Tayside NHS Forth Valley NHS Ayrshire & Arran NHS Greater Glasgow and Clyde 12 month BeWEL intervention vs. usual care 3 year study (start date 1 st Feb 2010) n=316 (158 intervention + 158 usual care)  6 months  24 months  6 months  Pre-trial developmentRecruitment, data collection & intervention implementation Final data collection, analysis & interpretation

13. Development work aims To explore prevention opportunities by colorectal adenoma diagnosis To inform engagement strategies for the BeWEL study

14. Methods 4 Focus group discussions Recruitment: Positive FOBt + adenoma removal within last 3 months Invitation letter and PIS sent Telephone screening: BMI ≥ 25 kg/m 2 Discussion guide Personal reactions to positive FOBt and adenoma diagnosis Perceived risk factors for adenoma and colorectal cancer Receptiveness to positive FOBt as opportunity for lifestyle advice Analysis Transcribed and thematic analysis conducted.

15. Recruitment Invitations n= 135 Yes n=38 (28%) No n=45 No Reply n=52 Exclusions (n=21): BMI < 25kg/m 2 (n=8) Not available for dates given/ changed mind/unwell (n=13) 4 x focus groups n=17 (5, 5, 2, 5)

16. Sample No. participants Males12 (71%) Females 5 (29%) SIMD  deciles 1-3 3 (18%) SIMD  deciles 4-7 8 (47%) SIMD  deciles 8-10 6 (35%)  Scottish Government Scottish Index of Multiple Deprivation (2009) www.scotland.gov.uk/Topics/Statistics/SIMD/

17. Perception of personal risk Participant: “I’d experienced no problems and I thought this was just something that had been picked up and it was better to get it sorted out.” Positive FOBt seen as a shock to some Adenomas perceived as a relatively minor abnormality Not always aware that adenomas could be pre-cancerous

18. Link between lifestyle factors and adenoma No information received on possible contributory factors, nor on prevention of recurrence

19. The ‘all clear’ message Moderator, reading from letter of invitation: “…....this means that you do not have bowel cancer and the fact that this has now been removed make it unlikely that you will develop this disease”. Moderator, reading from letter of invitation: “…....this means that you do not have bowel cancer and the fact that this has now been removed make it unlikely that you will develop this disease”. Participant: “To me that tells me I’m all clear......So why do I need to change my diet? My diet is alright. There is a mismatch somewhere. If my diet had caused this I would go along with that and I would change it.....” Reassuring ‘all clear’ message leads to confusion over need to change their lifestyle

20. Concept of lifestyle advice following adenoma Moderator: “So if someone said you’ve had your polyps removed. Now let’s look at your diet and your physical activity. How would you react to that? “ Participant: “If they said now that is caused by diet. Let’s look at your diet. Fine I would go along with that. But nobody at any time has said that was caused by your diet.”

21. Concept of lifestyle advice following adenoma Participant: “You say I think you could shed seven pounds and give a diet sheet to work on“ Moderator: “Are you saying that would be a good idea?” Participant: “I think it would be an excellent idea because you tend to look at yourself and you think I’m putting on a bit of weight, but do you do anything about it? You don’t. But if someone tells you, let’s see if we can get this weight down...........” Some welcomed the possibility of help to address aspects of lifestyle once the link had been accepted

22. Patient Advocacy Screening participants are generally very grateful for the treatment they have received Many feel they want to offer something back in return Feasibility study 1 also supports this. 1. Caswell S et al. (2009) Br J Nutr, 102, 1541-1546.

23. Conclusions from focus groups An unrecognised.... Window of Opportunity To promote a culture of prevention people must be made aware of the cancer / lifestyle relationship Without patient education we might just be providing a health certificate effect

24. Baseline assessments Randomisation Intervention GroupComparison Group 12 month follow up Exit interview Full invitation from research nurse: Sent within next 2 weeks 3 month follow up Colonoscopy results sent by post + “Teaser Letter” from consultant endorsing study Implications for BeWEL recruitment BeWEL 12-month programme

25. Implications for BeWEL recruitment Letter of introduction from consultant: “…I hope you find the results of your colonoscopy reassuring............... The ‘BeWEL’ study is based on evidence that physical activity, diet and body weight are linked to the recurrence of polyps, bowel cancer and other conditions. We wish to find out more about these factors in people who have had a polyp and we are studying ways to help people look at their diet, physical activity and body weight and to support them to make appropriate changes.”

26. Implications for BeWEL intervention Role of lifestyle counsellor To establish the awareness & promote prevention behaviour Concept of Risk reduction Importance of modest lifestyle change Consultant endorsement

27. Where we are now Recruitment ongoing since Oct 2010: 3 sites up and running 4 th site recently added (NHS Greater Glasgow & Clyde) N = 185 of target 316 recruited to date

28. Acknowledgements Investigators University of Dundee Prof Annie Anderson (PI) Prof Robert Steele (PI) Dr Shaun Treweek Prof Jill Belch Dr Fergus Daly NHS Tayside Joyce Thompson Jackie Rodger University College London Prof Jane Wardle University of Aberdeen Prof Anne Ludbrook University of Stirling Dr Martine Stead University of Strathclyde Dr Alison Kirk Collaborators NHS Tayside: Prof Robert Steele NHS Ayrshire & Arran: Mr Robert Diament NHS Forth Valley: Mr Wilson Hendry NHS Greater Glasgow and Clyde: Mr Derek Gillen Staff Trial manager: Caron Paterson and Erna Wilkie Deputy trial manager: Stephen Caswell Administrator: Jill Hampton Research Nurses and counsellors Funders The National Prevention Research Initiative:

29. Questions