Condition category
Cancer
Date applied
19/03/2014
Date assigned
07/04/2014
Last edited
19/01/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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 measures

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

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

http://www.tahsc.org/

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

Results - basic reporting

Publication summary

2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/25516158

Publication citations

Additional files

Editorial Notes