title: Breast cancer risk reduction--is it feasible to initiate a randomised controlled trial of a lifestyle intervention programme (ActWell) within a national breast screening programme?
abstract: BACKGROUND
  Breast cancer is the most commonly diagnosed cancer and the second cause of cancer deaths amongst women in the UK. The incidence of the disease is increasing and is highest in women from least deprived areas. It is estimated that around 42% of the disease in post-menopausal women could be prevented by increased physical activity and reductions in alcohol intake and body fatness. Breast cancer control endeavours focus on national screening programmes but these do not include communications or interventions for risk reduction. This study aimed to assess the feasibility of delivery, indicative effects and acceptability of a lifestyle intervention programme initiated within the NHS Scottish Breast Screening Programme (NHSSBSP).
  
  
  METHODS
  A 1:1 randomised controlled trial (RCT) of the 3 month ActWell programme (focussing on body weight, physical activity and alcohol) versus usual care conducted in two NHSSBSP sites between June 2013 and January 2014. Feasibility assessments included recruitment, retention, and fidelity to protocol. Indicative outcomes were measured at baseline and 3 month follow-up (body weight, waist circumference, eating and alcohol habits and physical activity). At study end, a questionnaire assessed participant satisfaction and qualitative interviews elicited women's, coaches, and radiographers' experiences. Statistical analysis used Chi squared tests for comparisons in proportions and paired t tests for comparisons of means. Linear regression analyses were performed, adjusted for baseline values, with group allocation as a fixed effect.
  
  
  RESULTS
  A pre-set recruitment target of 80 women was achieved within 12 weeks and 65 (81%) participants (29 intervention, 36 control) completed 3 month assessments. Mean age was 58 ± 5.6 years, mean BMI was 29.2 ± 7.0 kg/m(2) and many (44%) reported a family history of breast cancer. The primary analysis (baseline body weight adjusted) showed a significant between group difference favouring the intervention group of 2.04 kg (95% CI -3.24 kg to -0.85 kg). Significant, favourable between group differences were also detected for BMI, waist circumference, physical activity and sitting time. Women rated the programme highly and 70% said they would recommend it to others.
  
  
  CONCLUSIONS
  Recruitment, retention, indicative results and participant acceptability support the development of a definitive RCT to measure long term effects.
  
  
  BACKGROUND
  The trial was registered with Current Controlled Trials (ISRCTN56223933).
authors.affiliation: Centre for Research into Cancer Prevention and Screening, Cancer Division, Medical Research Institute, Level 7, Ninewells Hospital & Medical School, Dundee, DD1 9SY, UK. a.s.anderson@dundee.ac.uk.
authors.forename: Annie S
authors.initials: AS
authors.lastname: Anderson
authors.affiliation: Centre for Research into Cancer Prevention and Screening, Cancer Division, Medical Research Institute, Level 7, Ninewells Hospital & Medical School, Dundee, DD1 9SY, UK. m.macleod@dundee.ac.uk.
authors.forename: Maureen
authors.initials: M
authors.lastname: Macleod
authors.affiliation: Physical Activity for Health Research Centre, Moray House School of Education, St Leonard's Land, University of Edinburgh, Edinburgh, EH8 8AQ, UK. nanette.mutrie@ed.ac.uk.
authors.forename: Nanette
authors.initials: N
authors.lastname: Mutrie
authors.affiliation: Centre for Research into Cancer Prevention and Screening, Cancer Division, Medical Research Institute, Level 7, Ninewells Hospital & Medical School, Dundee, DD1 9SY, UK. J.A.Sugden@dundee.ac.uk.
authors.forename: Jacqueline
authors.initials: J
authors.lastname: Sugden
authors.affiliation: West of Scotland Breast Screening Service, Stock Exchange Court, 77 Nelson Mandela Place, Glasgow, G1 2QT, UK. hilary.dobson@ggc.scot.nhs.uk.
authors.forename: Hilary
authors.initials: H
authors.lastname: Dobson
authors.affiliation: Health Services Research Unit, University of Aberdeen, Health Sciences Building, Foresterhill, Aberdeen, AB25 2ZD, UK. streweek@mac.com.
authors.forename: Shaun
authors.initials: S
authors.lastname: Treweek
authors.affiliation: Division of Psychology, School of Natural Sciences, Stirling University, Stirling, FK9 4LA, UK. ronan.ocarroll@stir.ac.uk.
authors.forename: Ronan E
authors.initials: RE
authors.lastname: O'Carroll
authors.affiliation: Department of Surgery, Dundee Cancer Centre, Mailbox 4, Ninewells Hospital & Medical School, Dundee, DD1 9SY, UK. a.m.thompson@dundee.ac.uk.
authors.forename: Alistair
authors.initials: A
authors.lastname: Thompson
authors.affiliation: Physical Activity for Health Research Group, School of Psychological Sciences and Health, University of Strathclyde, Glasgow, G1 1QE, UK. alison.kirk@strath.ac.uk.
authors.forename: Alison
authors.initials: A
authors.lastname: Kirk
authors.affiliation: Institute of Health and Wellbeing, College of Social Sciences, Room 227 27 Bute Gardens, University of Glasgow, Glasgow, G12 8RS, UK. Graham.Brennan@glasgow.ac.uk.
authors.forename: Graham
authors.initials: G
authors.lastname: Brennan
authors.affiliation: Institute of Health and Wellbeing, College of Social Sciences, Room 227 27 Bute Gardens, University of Glasgow, Glasgow, G12 8RS, UK. Sally.Wyke@glasgow.ac.uk.
authors.forename: Sally
authors.initials: S
authors.lastname: Wyke
mesh_terms: D000428:Alcohol Drinking; D015992:Body Mass Index; D001835:Body Weight; D001943:Breast Neoplasms / Q000517:prevention & control*; D003710:Demography; D005240:Feasibility Studies; D005247:Feeding Behavior; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008019:Life Style; D008875:Middle Aged; D009043:Motor Activity; D016032:Randomized Controlled Trials as Topic; D012307:Risk Factors; D040242:Risk Reduction Behavior; D013222:State Medicine; D011795:Surveys and Questionnaires; D016896:Treatment Outcome; D055105:Waist Circumference