1. Indicative findings from a feasibility study of the ActWELL intervention to reduce breast cancer risk factors
Dr Maureen Macleod
University of Dundee

5. Scottish Health Survey, 2013

7. Recruitment and Retention

8. Background
Evans et al (2010) Studies to recruit high risk women from BS weight loss trials using mailed invitation 12.5% (40/340) and 6.2% (50/797) entered a randomised study did not vary by breast cancer risk.
Harvie et al (2010) reports 13% (80/605) randomised in high risk group
Aim
Recruit 40 women from static screening clinics (current attendance over two sites is estimated at 442 per week 40/3536 (1.1%).
Recruit 40 women from recall clinics (current attendance over two sites is 85 per week) 40/680 (5.8%)

9. Recruitment - routine screening clinics
Receptionist gave brief leaflet plus endorsement letter
Radiographers endorsed study and collected phone numbers
Researchers then provided verbal information by phone and post full information sheet and pre-paid reply slip
Interested participants were then contacted to make baseline measures appointment

10. Recruitment – recall clinics
Women received an endorsement letter, brief information sheet and pre-paid reply slip after a clear result had been received
Interested participants were contacted, provided verbal information by phone and screened. Full PIS was sent.
Researchers then made a baseline measures appointment

11. Baseline measures Anthropometry – height weight waist circumference
BMI
Blood pressure
Nurse led questionnaire –
demographic and clinical characteristics
eating habits (DINE)
alcohol intake
physical activity and sitting time (IPAQ)

12. All participants got……

13. ActWELL Intervention
Delivery - one hour face to face plus fortnightly calls for 12 weeks by lifestyle counsellors
Content focus- body weight, physical activity, diet (including alcohol consumption)
Behavioural components- endorsement, interactive tasks, goal setting, self monitoring, feedback

14. Adults potentially given study information People expressing interest
ActWELL Recruitment – ALL
Adults potentially given study information
(n=1285) (966 routine, 319 recall)
People expressing interest
(n= 168, 13%)
(105 routine, 63 recall)
Progress
Not contactable n=27 (16%)
Changed mind n=13 (8%)
Too late to join study = 28 (17%)
Said yes but not required =15 (9%)
Randomised n=80

15. ActWELL Recruitment - Routine screening
Adults potentially given study information plus enquiry
(n=230)
Responded yes to leaflet only n=5
Responded yes to study info plus pack n=100
People expressing interest from all routes
(n= 105)
Progress
Not contactable n=25 (24%)
Changed mind n=7 (6%)
Too late to join study = 13 (12%)
Said yes but not required =15 (14%)
Randomised n=40

16. Adults potentially given study information People expressing interest
ActWELL Recruitment - Recall Clinic
Adults potentially given study information
(319 recall)
People expressing interest
(63 recall)
Progress
Not contactable n=2 (3.2%)
Changed mind n=6 (9.5%)
Too late to join study = 15 (23.8%)
Randomised n=40

17. What motivated people to take part?
Participate in research
Help other people
Had a family member or friend who had had cancer
Opportunity to improve their health.
Don’t know
Personal breast cancer risk reduction didn’t stand out!

18. Comments on recruitment
Radiographers  “[Our role was] just to ask them if they were interested and take the numbers but we didn’t advise them in any way at all”. (RadD1) “It was really difficult to go over things, and people did want to ask you and we had to stop a lot of ladies saying ‘keep your questions for [the research coordinator]”. (RadD2)

19. Participant comments
the leaflets worked, endorsement by staff was patchy and from radiology staff, almost non-existent.
To recruit less motivated women will require more engaging adaptations
Suggestions:
pre-notification for all participants
dedicated staff member

20. ActWELL Retention – 81% overall
Allocated to intervention (n=40)
Allocated to control (n=40)
3 month loss to follow-up n=4 (10%)
Unhappy with group n=1
Unable to contact n=2
Other n=1
(recall n=3, screening n=1)
3 month loss to follow-up n=11 (28%)
Health problems n=4
Unable to contact n=6
Other n=1
(Recall n=6, Screening n=5)
3 withdrew before face to face
2 after some calls
6 after all calls
3 month follow-up
(n=29) 72%
70% recall, 85% screening
3 month follow-up
(n=36) 95%
85% recall, 95% screening

21. Completion of measures
Anthropometric measures
Baseline n= 80, Follow up completed by 65 (64 for WC) (28 IV and 36 control)
Questionnaire data
Baseline n=80, Follow up n=65 (1IV by post)
Exit study questionnaires
completed by (25(86%) IV and 32(89%) control)
Exit Qualitative interviews – completed by 14 (IV)

22. Intervention delivery
All 29 completers had a face to face interview with the lifestyle coach and 26 had all fortnightly calls
Mean duration of time participating in the study was 108 days (range 84 to 182 days)
Mean duration of face to face consultations 90 minutes (range 65 to 130 minutes)
Mean duration of telephone consultations 22 minutes (range 10 to 54 minutes)

23. Baseline characteristics
SIMD %
SIMD %
Breast Feeding
55%
Family history of Breast Cancer
43.8%

24. Changes in anthropometric measures from baseline to 3 months by randomisation group

25. % body weight loss
The mean % weight loss at 3 months in the intervention group was 2.74 ± 3.39% compared to 0·19 ± 3.20% in the control arm.
The group difference was 2.54% (95%CI to -0.90).
The proportion of participants who lost 5% body weight was higher in the intervention group than the control group (21% vs. 6%, p=0.07)
The intervention group showed an odds ratio (OR) of 4.44 (95%CI 0.82 to 23.93) of achieving 5% weight loss (compared to the control group)

26. Changes in self-reported dietary intake and physical activity (PA) from baseline to 3 months by randomisation group

27. Alcohol consumers only

28. Overview from exit questionnaires

29. Participants views on the intervention(exit questionnaires)

30. Issues for future RCT
The primary outcome of the future RCT will be weight management (maintenance/loss)
The secondary outcomes will be physical activity, diet and alcohol intake and cancer risk beliefs.

31. Sample size for full trial
All participants, regardless of weight (n=80 in feasibility study):
Mean = 75.78kg, St Dev 17.66kg
Significance level = Power 80%
Sample size required to detect 5% weight loss (-3.79kg) = 342 per group (684 in total)
Sample size required to detect 7% weight loss (-5.30kg) = 175 per group (350 in total)
Overweight participants (n=57 in feasibility study):
Mean = 81.21kg, St Dev 17.87kg
Significance level = Power 80%
Sample size required to detect 5% weight loss (-4.06kg) = 306 per group (612 in total)
Sample size required to detect 7% weight loss (-5.68kg) = 157 per group (314 in total)

32. Investigators:
Annie S. Anderson, Jacqui Sugden ,University of Dundee
Nanette Mutrie, University of Edinburgh
Sally Wyke, Ellie Conway University of Glasgow
and the ActWELL team
Funding Chief Scientist Office, Scottish Govt