Transcript The BeWEL study - implications for raising awareness of cancer

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:
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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:
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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
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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
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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
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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