Promoting wellbeing, equality, and support in breast cancer survivorship

ISRCTN	ISRCTN14016157
DOI	https://doi.org/10.1186/ISRCTN14016157
Protocol serial number	PROWESS protocol v1
Sponsor	Breast Cancer Care (UK)
Funder	Big Lottery Fund (UK) ref. RGT/1/010334410

Submission date: 26/03/2014
Registration date: 28/04/2014
Last edited: 06/06/2018

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

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

http://www.cancerresearchuk.org/about-cancer/find-a-clinical-trial/a-study-looking-at-a-support-programme-for-women-after-breast-cancer-treatment-prowess

Contact information

Ms Karen Scanlon
Scientific

Breast Cancer Care
5-13 Great Suffolk Street
London
SE1 ONS
United Kingdom

Phone	+44 (0)20 7960 3467
Email	karen.scanlon@breastcancercare.org.uk

Study information

Primary study design	Interventional
Study design	Open two-armed (1:1) multicentre randomised controlled trial with a process evaluation
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
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 acronym	PROWESS
Study objectives	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(s)	NRES Committee East of England - Essex, 13/10/2014, ref: 14/EE/0124 - approval pending
Health condition(s) or problem(s) studied	Breast cancer survivorship
Intervention	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	Behavioural
Primary outcome measure(s)	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.
Key secondary outcome measure(s)	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
Completion date	31/12/2015

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Female
Target sample size at registration	60
Key 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
Key exclusion criteria	Patients with primary invasive breast cancer but who: 1. have completed hospital treatment MORE than 12 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
Date of first enrolment	01/05/2014
Date of final enrolment	31/12/2015

Locations

Countries of recruitment

United Kingdom

Study participating centre

Breast Cancer Care

London
SE1 ONS
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

06/06/2018: No publications found, verifying study status with principal investigator.
25/05/2016: Ethics approval information added.