Plain English Summary
Background and study aims
Breast cancer is diagnosed in over 4,500 women in Scotland each year and this number is rising (13.7% increase between 2001 and 2011). We know that around 40% of post-menopausal breast cancers could be prevented by following dietary (including alcohol consumption), weight management and physical activity guidelines for cancer prevention. There is some evidence that women attending breast cancer screening are interested in receiving lifestyle advice although neither this or the response to this approach has been formally assessed. This study aims to assess the response of women to lifestyle advice as part of breast cancer screening.
Who can participate?
Women attending NHS breast screening clinics who have a BMI greater than 20kg/m2 and no contraindication to physical activity or weight loss.
What does the study involve?
At the start of the study and after 3 months, height, weight and waist circumference will be recorded, sitting blood pressure measured, a 24 hour dietary recall and questionnaires on health behaviours, diet (including alcohol consumption) and physical activity will be completed. Based on the initial measures, women will be randomly allocated to one of two groups: ActWELL group (advice) or usual care (booklet only). The advice will be delivered via a one hour counselling session (face to face) with a lifestyle coach and fortnightly telephone consultations for 3 months. It will focus on body weight, diet and physical activity. The face to face session will be interactive and include a 10 minute walk and talk session, self-identification of BMI from standard coloured charts and measurement of one standard unit of alcohol using a wine coloured liquid. Behavioural techniques will be used including goal setting, action plans, implementation intentions, coping planning and self-monitoring.
What are the possible benefits and risks of participating?
Possible benefits include weight loss, a healthier lifestyle, fewer risks of all obesity related chronic diseases which are major causes of death in the UK. No risks are foreseen from participation.
Where is the study run from?
University of Dundee (UK)
When is the study starting and how long is it expected to run for?
The study started on 1st Dec 2012, recruitment started on 7th June 2013 and ended on 28th February 2013 and a final report will be available on April 30th 2014.
Who is funding the study?
Chief Scientist Office (UK)
Who is the main contact?
Prof Annie Anderson
a.s.anderson@dundee.ac.uk
Trial website
Contact information
Type
Scientific
Primary contact
Prof Annie Anderson
ORCID ID
Contact details
Centre for Research into Cancer Prevention and Screening
Cancer Division
Medical Research Institute
Level 7
Ninewells Medical School
Dundee
DD1 9SY
United Kingdom
+44 (0) 1382 383299
a.s.anderson@dundee.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
13811
Study information
Scientific title
ActWELL - working together to support ACTive living and WELLbeing in the health-promoting health service - a feasibility trial to reduce breast cancer risk factors
Acronym
ActWELL
Study hypothesis
It is feasible to deliver a minimal contact behaviour change intervention (ActWELL) initiated within the breast cancer screening setting and achieve significant improvement in lifestyle behaviours over a 3-month period.
More details can be found here: http://public.ukcrn.org.uk/Search/StudyDetail.aspx?StudyID=13811
Ethics approval
East of Scotland Research Ethics Service, 09/10/2012, REC ref: 12/ES/0087.
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Prevention
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Breast cancer/cancer screening/cancer prevention
Intervention
Participants were randomised (1:1) to either the ActWELL intervention or usual care (booklet only).
The ActWELL intervention consisted of a 1-hour counselling session (face to face) with a lifestyle coach and fortnightly follow-up telephone consultations for 3 months with access to written/online support materials. The face-to-face session was designed to be interactive and included a 10-minute walk and talk session, self-identification of Body Mass Index from standard coloured charts and measurement of one standard unit of alcohol using a wine-coloured liquid. Behavioural techniques were used including goal setting, action plans, implementation intentions, coping planning and self-monitoring.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measure
1. Feasibility outcomes - programme implementation, fidelity to protocol, achieved measurements, recruitment, response, early retention and reported adherence. Acceptability measures of recruitment, implementation and exit strategy (i.e., signposting to further support)
2. Indicative findings - primary outcome was weight change, measured at baseline and follow up (after 3 months)
Secondary outcome measures
1. Indicative findings measured at baseline and follow up (after 3 months):
1.1. Changes in waist circumference
1.2. Changes in blood pressure
1.3. Changes in physical activity (International Physical Activity Questionnaire Short form)
1.4. Changes in diet and alcohol habits (dietary instrument for nutrition education, 24 h diet recall, 7-day alcohol record)
Overall trial start date
01/04/2013
Overall trial end date
30/04/2014
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Participation in the NHS breast cancer screening programme (age range 50 75 years)
Participant type
Patient
Age group
Other
Gender
Female
Target number of participants
80
Participant exclusion criteria
1. Breast cancer diagnosis
2. BMI < 20 kg/m2
3. Any known contra-indicators to physical activity or weight management
Recruitment start date
01/04/2013
Recruitment end date
30/04/2014
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Centre for Research into Cancer Prevention and Screening
Dundee
DD1 9SY
United Kingdom
Sponsor information
Organisation
Tayside Medical Science Centre (UK)
Sponsor details
c/o Vera Nuritova
TASC R&D Office
Ninewells Hospital and Medical School
Residency Block Level 3
George Pirie Way
Dundee
DD1 9SY
United Kingdom
+44 (0) 1382 383877
f.nuritova@dundee.ac.uk
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Government
Funder name
Chief Scientist Office (UK) (CHZ/4/745)
Alternative name(s)
CSO
Funding Body Type
government organisation
Funding Body Subtype
government non-federal
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/25516158