Promoting wellbeing, equality, and support in breast cancer survivorship
| ISRCTN | ISRCTN14016157 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN14016157 |
| Secondary identifying numbers | PROWESS protocol v1 |
- 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
Contact information
Ms Karen Scanlon
Scientific
Scientific
Breast Cancer Care
5-13 Great Suffolk Street
London
SE1 ONS
United Kingdom
| Phone | +44 (0)20 7960 3467 |
|---|---|
| karen.scanlon@breastcancercare.org.uk |
Study information
| Study design | Open two-armed (1:1) multicentre randomised controlled trial with a process evaluation |
|---|---|
| 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 to request a patient 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 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(s) | NRES Committee East of England - Essex, 13/10/2014, ref: 14/EE/0124 - approval pending |
| Condition | 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 | 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 study start date | 01/05/2014 |
| Overall study end date | 31/12/2015 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target number of participants | 60 |
| 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 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 |
| Recruitment start date | 01/05/2014 |
| Recruitment end date | 31/12/2015 |
Locations
Countries of recruitment
- United Kingdom
Study participating centre
Breast Cancer Care
London
SE1 ONS
United Kingdom
SE1 ONS
United Kingdom
Sponsor information
Breast Cancer Care (UK)
Charity
Charity
5 - 13 Great Suffolk Street
London
SE1 0NS
United Kingdom
"ROR" |
https://ror.org/00w85kx21 |
|---|
Funders
Funder type
Charity
Big Lottery Fund (UK) ref. RGT/1/010334410
Private sector organisation / Other non-profit organizations
Private sector organisation / Other non-profit organizations
- Alternative name(s)
- BIG
- Location
- United Kingdom
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Editorial Notes
06/06/2018: No publications found, verifying study status with principal investigator.
25/05/2016: Ethics approval information added.
