Promoting wellbeing, equality, and support in breast cancer survivorship

Authors
Category Primary study
Registry of TrialsISRCTN registry
Year 2014
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. CONDITION: Breast cancer survivorship ; Cancer PRIMARY OUTCOME: 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: 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 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
Epistemonikos ID: dfaf67d68c8839fa820762a6465715d0826297cb
First added on: Aug 23, 2024