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

Scottish Health Survey, 2013

Recruitment and Retention

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%)

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

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

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)

All participants got……

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

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

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

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

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!

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)

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

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

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)

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)

Baseline characteristics SIMD 1 12.5% SIMD 2 17.5% Breast Feeding 55% Family history of Breast Cancer 43.8%

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

% 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 -4.18 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)

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

Alcohol consumers only

Overview from exit questionnaires

Participants views on the intervention(exit questionnaires)

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.

Sample size for full trial All participants, regardless of weight (n=80 in feasibility study): Mean = 75.78kg, St Dev 17.66kg Significance level = 0.05 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 = 0.05 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)

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 email: a.s.anderson@dundee.ac.uk Funding Chief Scientist Office, Scottish Govt