Condition category
Date applied
Date assigned
Last edited
Prospectively registered
Overall trial status
Recruitment status
No longer recruiting

Contact information



Primary contact

Ms Karen Scanlon


Contact details

Breast Cancer Care
5-13 Great Suffolk Street
United Kingdom
+44 (0)20 7960 3467

Additional identifiers

EudraCT number number

Protocol/serial number

PROWESS protocol v1

Study information

Scientific title

A feasibility study of delivering a culturally adapted group-based breast cancer self-management intervention in a community setting, designed to enhance confidence to self-manage following treatment for primary breast cancer and promote peer support, among women from different ethnic and socio-economic backgrounds



Study hypothesis

The overall aims of this study are to develop a culturally adapted self-management intervention for primary breast cancer patients from diverse ethnic and socio-economic backgrounds to be delivered in a community setting; and to assess the cultural appropriateness and acceptability of the content, mode of delivery, and outcome measures in a feasibility trial. The main research question is: "Can a self-management intervention for primary breast cancer patients be designed and delivered to be culturally relevant and engaging for patients in a community setting?" This research is based on the overarching hypothesis that culturally appropriate self-management interventions will improve patient acceptability and be more effective in increasing self-efficacy than standard care.

Ethics approval

NRES Committee East of England - Essex - approval pending, 13/10/2014, ref: 14/EE/0124

Study design

Open two-armed (1:1) multicentre randomised controlled trial with a process evaluation

Primary study design


Secondary study design

Randomised controlled trial

Trial setting


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


Breast cancer survivorship


Intervention arm: Participants in the intervention arm with be invited to attend the PROWESS intervention. This is a culturally appropriate group based self-management intervention in a community setting for women from different ethnic and socio-economic backgrounds, who are within 12 months of completing active treatment. This course aims to provide expert advice in addition to increasing peer support by allowing them to share their experiences with other survivors in a culturally appropriate environment. The PROWESS study intervention is currently in the process of being developed using a co-design approach involving patients and stakeholders. The length of the intervention has not been established yet, but we currently envisage one weekly 3 to 4 hour long sessions per week for 3 to 5 weeks each, resulting in a minimum of 9 to a maximum of 20 hours in total. The intervention will take place at one of four community settings, two of which will be faith based, e.g. a church hall, and two of which non-faith based, e.g. a library. Participants will be given the choice between faith and non-faith based settings, but it will be made clear that it might not be possible to match their preference if numbers at one venue are too low.

Control arm: Participants in the control arm will receive standard care. To ensure that every patient participating in this study will receive the care and support they need, a waitlist control will be used. Patients in the control will be invited to attend the PROWESS survivorship course, one month after study completion, which will be around 8 months after randomisation.

Intervention type



Drug names

Primary outcome measures

Feasibility and acceptability of the culturally adapted self-management intervention for primary breast cancer patients from diverse ethnic and social backgrounds, which will be assessed using both quantitative and qualitative measures.

Secondary outcome measures

1. Self efficacy will be measured using the Self-Efficacy for Managing Chronic Disease 6item Measure. In the feasibility study this will be used to inform sample size calculations for the randomised controlled trial and to assess the feasibility/acceptability of obtaining this measure.
2. The acceptability and feasibility of obtaining the following measures will also be assessed to determine their use as secondary outcome measures in the subsequent randomised controlled trial:
2.1. Exercise behaviour
2.2. Diet awareness and readiness to change (adopted from the California Department of Public Health Nutrition Risk Screening Questionnaire)
2.3. Breast cancer knowledge
2.4. The Brief Illness Perception Questionnaire (BIPQ)
2.5. Quality of life (FACTB)
2.6. Hospital Anxiety and Depressions Scale (HADS)
2.7. The Friendship Scale

Overall trial start date


Overall trial end date


Reason abandoned


Participant inclusion criteria

1.Patients diagnosed with primary invasive breast cancer
2. Completed active hospital based treatment in the last twelve months (likely to have included surgery, chemotherapy, radiotherapy)
3. Either continuing treatment on hormone therapies and monoclonal antibodies or Herceptin
4. Able to provide informed consent
5. English speaking

Participant type


Age group




Target number of participants


Participant exclusion criteria

Patients with primary invasive breast cancer but who
1. have completed hospital treatment MORE than twelve months ago
2. are receiving chemotherapy or radiotherapy treatment
3. are non English speaking
4. are not able to give written informed consent
5. have previously attended a cancer self-management/ survivorship course including Breast Cancer Care's Moving Forward course

Recruitment start date


Recruitment end date



Countries of recruitment

United Kingdom

Trial participating centre

Breast Cancer Care
United Kingdom

Sponsor information


Breast Cancer Care (UK)

Sponsor details

5 - 13 Great Suffolk Street
United Kingdom

Sponsor type




Funder type


Funder name

Big Lottery Fund (UK) ref. RGT/1/010334410

Alternative name(s)

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit


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

Publication citations

Additional files

Editorial Notes

25/05/2016: Ethics approval information added.