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 Overview • Background rationale • BeWEL RCT Study design • Development work and challenges Summary Statistics for Colorectal Cancer (CRC) in Scotland Scotland Males Females 3 3 15.0% 11.6% Number of new cases diagnosed in 2009 2135 1781 Number of deaths recorded in 2009 782 719 Change in incidence from 1994 to 2004 - 1.4% -1.0% Change in mortality from 1999 to 2009 -20.7% -12.3% Rank Mortality Percentage frequency of all cancers ISD Scotland, 2011 Development of Colorectal Cancer • FAP - Familial adenomatous polyposis • HNPCC - Hereditary nonpolyposis colorectal cancer • For the majority CRC is an example of a genetic / environmental interaction Modifiable risk factors for CRC CONVINCING Decreases Risk Increases Risk Physical activity Red meat Processed meat Alcoholic drinks (men) Body fatness Abdominal fatness PROBABLE Foods containing dietary fibre Garlic Milk Calcium Alcoholic drinks (women) WCRF / AICR (2007) Food, nutrition, physical activity and the prevention of cancer: a global perspective WCRF / AICR (2011) Continuous update project. WCRF / AICR (2007) Food, nutrition, physical activity and the prevention of cancer: a global perspective FOBT Screening for Colorectal Cancer 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. Colorectal Cancer Screening : “A Window of Opportunity” • Screening awakens curiosity about disease and its causes1: 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. Colorectal cancer screening as a teachable moment? • +ve FOBt a time of raised anxiety • Adenoma – pre-curser to cancer 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 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 1st Feb 2010) • n=316 (158 intervention + 158 usual care) 6 months 24 months 6 months Pre-trial development Recruitment, data collection & intervention implementation Final data collection, analysis & interpretation Development work aims • To explore prevention opportunities by colorectal adenoma diagnosis • To inform engagement strategies for the BeWEL study Methods • 4 Focus group discussions • Recruitment: • Positive FOBt + adenoma removal within last 3 months • Invitation letter and PIS sent • Telephone screening: BMI ≥ 25 kg/m2 • 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. Recruitment Invitations n= 135 No n=45 Yes n=38 (28%) No Reply n=52 Exclusions (n=21): • BMI < 25kg/m2 (n=8) • Not available for dates given/ changed mind/unwell (n=13) 4 x focus groups n=17 (5, 5, 2, 5) Sample No. participants Males Females SIMD deciles 1-3 SIMD deciles 4-7 12 (71%) 5 (29%) 3 (18%) 8 (47%) SIMD deciles 8-10 6 (35%) Scottish Government Scottish Index of Multiple Deprivation (2009) www.scotland.gov.uk/Topics/Statistics/SIMD/ Perception of personal risk • Positive FOBt seen as a shock to some • Adenomas perceived as a relatively minor abnormality • Not always aware that adenomas could be pre-cancerous 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.” Link between lifestyle factors and adenoma • No information received on possible contributory factors, nor on prevention of recurrence The ‘all clear’ message • Reassuring ‘all clear’ message leads to confusion over need to change their lifestyle 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.....” 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.” Concept of lifestyle advice following adenoma • Some welcomed the possibility of help to address aspects of lifestyle once the link had been accepted 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...........” 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 study1 also supports this. 1. Caswell S et al. (2009) Br J Nutr, 102, 1541-1546. 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 Implications for BeWEL recruitment Colonoscopy results sent by post + “Teaser Letter” from consultant endorsing study Full invitation from research nurse: Sent within next 2 weeks Baseline assessments Randomisation Intervention Group Comparison Group 3 month follow up BeWEL 12-month programme 12 month follow up Exit interview 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.” 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 Where we are now • Recruitment ongoing since Oct 2010: • 3 sites up and running • 4th site recently added (NHS Greater Glasgow & Clyde) • N = 185 of target 316 recruited to date 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: Questions