PROCAS: Lifestyle Breast Cancer Prevention Feasibility Study

ISRCTN	ISRCTN91372184
DOI	https://doi.org/10.1186/ISRCTN91372184
Secondary identifying numbers	17480

Submission date: 26/09/2014
Registration date: 26/09/2014
Last edited: 24/11/2021

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Cancer

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

http://www.cancerresearchuk.org/about-cancer/trials/a-study-looking-whether-information-about-risk-affects-whether-women-follow-weight-loss-programme-procas-lifestyle-study

Contact information

Mrs Mary Pegington
Scientific

The Nightingale Centre
Wythenshawe Hospital
Southmoor Road
Manchester
M23 9LT
United Kingdom

Phone	+44 161 291 4854
Email	mary.pegington@manchester.ac.uk

Study information

Study design	Randomised; Interventional; Design type: Prevention
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Quality of life
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title	PROCAS: Lifestyle Breast Cancer Prevention Feasibility Study: randomised controlled study
Study acronym	PROCAS
Study objectives	Does personalised information about risk of cardiovascular disease and diabetes enhance uptake and adherence to a weight loss programme amongst women who receive breast cancer risk feedback in the NHS Breast Cancer?
Ethics approval(s)	West Midlands - Solihull Research Ethics Committee, 09/09/2014, ref: 14/WM/1088
Health condition(s) or problem(s) studied	Topic: Cancer; Subtopic: Breast Cancer; Disease: Breast
Intervention	172 overweight women currently enrolled on the PROCAS Study will be randomly assigned to a weight loss / lifestyle programme with either: 1. A standard care group (n = 40) A reminder their individual breast cancer risk and information that weight loss of >5% and lifestyle change can reduce this risk by 25%-30%. They will receive general (not personalised) information on the likely reductions in risk of other diseases with > 5% weight loss/ lifestyle change . 2. An NHS health check group (n = 80) As above but they will also receive an NHS health check and personalised information on their risk of developing cardiovascular disease and Type 2 diabetes. This group will be informed that weight loss of >5% and lifestyle change can reduce their risk of breast cancer by 25%- 30%, their risk of diabetes by 60% and CVD by 30%. All participants are seen at baseline, three and six months.
Intervention type	Other
Primary outcome measure	Weight, body fat and fat-free mass are measured at baseline, 3 and 6 months
Secondary outcome measures	1. Biomarkers of CVD (lipids, systolic and diastolic blood pressure), diabetes (HbA1c) are measured at baseline, 3 and 6 months 2. Quality of life is measured using the SF-36 questionnaire at baseline, 3 and 6 months 3. Health status is measured using the EQ-5D questionnaire at baseline, 3 and 6 months
Overall study start date	05/04/2012
Completion date	01/12/2017

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Female
Target number of participants	172
Total final enrolment	178
Key inclusion criteria	1. Attending the NHSBSP aged 47 - 74 years and part of the PROCAS study 2. Women who have previously received feedback of their personalised breast cancer risk by phone / face to face / letter 3. BMI ≥25 kg/m2 as breast cancer risk is seen amongst overweight as well as obese women 4. Access to and ability to use a telephone and high/moderate-speed internet 5. Women in the North, Central and South Manchester Clinical Commissioning Groups who are eligible for NHS health check with Public Health Manchester 6. Agree that results of any NHS health checks conducted in the study can be communicated back to their GP. This is a requirement of NHS health checks to allow patients with undiagnosed CVD or diabetes or high risks of these diseases to receive appropriate follow up tests and medical management.
Key exclusion criteria	Exclusion criteria as of 03/11/2016: 1. Previous diagnosis of cancer, diabetes, CVD or receiving medication for raised cholesterol. Women with previous non-melanoma skin cancer or cervical intra-epithelial neoplasia will be accepted. 2. Physical or psychiatric condition which precludes suitability or adherence to a home-based diet and exercise programme 3. Current user of hormone replacement therapy (weight affects breast cancer risk amongst non-HRT users only) 4. Advanced renal failure and attending a pre dialysis clinic. 5. Currently successfully following a diet and/or exercise plan and have lost more than 2 lb (1 kg) of weight in the last 2 weeks Original exclusion criteria: 1. Previous diagnosis of cancer, diabetes, CVD or receiving medication for raised cholesterol 2. Physical or psychiatric condition which precludes suitability or adherence to a home-based diet and exercise programme 3. Current user of hormone replacement therapy (weight affects breast cancer risk amongst non-HRT users only)
Date of first enrolment	01/10/2014
Date of final enrolment	01/12/2016

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Wythenshawe Hospital

Nightingale Centre
Southmoor Road
Manchester
M23 9LT
United Kingdom

Sponsor information

University Hospital of South Manchester NHS Foundation Trust
University/education

Research and Development Directorate
First Floor NIHR Building
Southmoor Road
Manchester
M23 9LT
England
United Kingdom

Phone	+44 161 291 5777
Email	uhsm.rd@manchester.ac.uk
"ROR"	https://ror.org/00he80998

Funders

Funder type

Charity

Prevent Breast Cancer Limited

No information available

Results and Publications

Intention to publish date	31/12/2019
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Data sharing statement to be made available at a later date
Publication and dissemination plan	Planned publication in a high-impact peer reviewed journal.
IPD sharing plan	The current data sharing plans for the current study are unknown and will be made available at a later date.

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Other publications	reply to comment	01/03/2020	05/06/2020	Yes	No
Results article	results	04/12/2019	05/06/2020	Yes	No
Plain English results		24/11/2021	24/11/2021	No	Yes
HRA research summary			28/06/2023	No	No

Editorial Notes

24/11/2021: Cancer Research UK lay results summary link added.
05/06/2020: Publication references added.
21/06/2019: The following changes were made to the trial record:
1. The total final enrolment number was added.
2. The intention to publish date was changed from 31/12/2018 to 31/12/2019.
09/11/2016: The following changes have been made to the record:
1. The sponsor contact information has been added
2. The overall trial start date has been updated from 01/10/2014 to 05/04/2012
3. The publication and dissemination plan and IPD sharing plan have been added.
03/11/2016: The following changes have been made to the record:
1. The overall trial end date has been updated from 31/3/2015 to 01/12/2017 and the recruitment end date has been updated from 31/03/2015 to 01/12/2016
2. The target number of participants has been updated from 120 to 172
3. The exclusion criteria have been updated
4. The funder name has been changed from Genesis Breast Cancer Prevention Appeal Ltd to Prevent Breast Cancer Limited