Condition category
Cancer
Date applied
26/09/2014
Date assigned
26/09/2014
Last edited
09/11/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

Contact information

Type

Scientific

Primary contact

Mrs Mary Pegington

ORCID ID

Contact details

The Nightingale Centre
Wythenshawe Hospital
Southmoor Road
Manchester
M23 9LT
United Kingdom
+44 161 291 4854
mary.pegington@manchester.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

17480

Study information

Scientific title

PROCAS: Lifestyle Breast Cancer Prevention Feasibility Study: randomised controlled study

Acronym

PROCAS

Study hypothesis

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

West Midlands - Solihull Research Ethics Committee, 09/09/2014, ref: 14/WM/1088

Study design

Randomised; Interventional; Design type: Prevention

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Quality of life

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

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

Phase

Not Applicable

Drug names

Primary outcome measures

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 trial start date

05/04/2012

Overall trial end date

01/12/2017

Reason abandoned

Eligibility

Participant 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.

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

172

Participant 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)

Recruitment start date

01/10/2014

Recruitment end date

01/12/2016

Locations

Countries of recruitment

United Kingdom

Trial participating centre

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

Sponsor information

Organisation

University Hospital of South Manchester NHS Foundation Trust

Sponsor details

Research and Development Directorate
First Floor NIHR Building
Southmoor Road
Manchester
M23 9LT
United Kingdom
+44 161 291 5777
uhsm.rd@manchester.ac.uk

Sponsor type

University/education

Website

Funders

Funder type

Charity

Funder name

Prevent Breast Cancer Limited

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

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.

Intention to publish date

31/12/2018

Participant level data

To be made available at a later date

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

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