PREM-SBC
Research type
Research Study
Full title
PREM-SBC: Developing a Patient Reported Experience Measure in Secondary Breast Cancer
IRAS ID
220615
Contact name
Carole Farrell
Contact email
Sponsor organisation
The Christie NHS Foundation Trust
Duration of Study in the UK
0 years, 6 months, 1 days
Research summary
Patients' and informal caregivers’ experiences of treatment and care is a major indicator of quality and is used as a metric for improvements in healthcare. There has been significant expansion in the development and application of patient reported questionnaires that measure care experiences; Patient Reported Experience Measures (PREM). There is no available PREM for patients with secondary breast cancer. This study aims to develop and test a PREM in Secondary Breast Cancer (PREM-SBC) for clinical application.
All patients will be receiving clinical care at The Christie:
Stage I: 25 patients with secondary breast cancer will be asked to participate in face-to-face interviews with the researcher(s) to discuss experiences of clinical care. Patients’ informal caregivers will be invited to participate in separate interviews to discuss their experiences.
Stage II: From Stage I, potential items for PREM-SBC will be extracted and ~8-10 patients will be asked to attend a face-to-face interview with the researcher(s) to ensure items are clear and understandable.
Stage III: ~100 patients will complete a draft PREM-SBC,the validated quality of life questionnaires: EORTC-QLQ-C30, EORTC QLQ-BR23, the Hospital Anxiety and Depression Scale, Concerns Checklist and debriefing questionnaire. If appropriate the following will be completed: EORTC QLQ-BM22 (patients with bone metastases), The Palliative Care Quality of Life Instrument (patients in their last year of life), EORTC QLQ-ELD14 (patients >65 years). 50 patients will repeat the PREM-SBC, debriefing questionnaire and a scale of global change one week later.
Stage IV: The PREM-SBC and debriefing questionnaire will be tested with ~25 patients to assess its feasibility for routine collection of patient experience data.
Eligible patients will be one of the following: 1) Newly diagnosed with secondary breast cancer (within last 3 months); 2) Undergoing palliative chemotherapy; 3) Undergoing other palliative systemic treatment; 4) Patients with bone metastases only; 5) Receiving best supportive care undergoing no further anti-cancer treatment.
REC name
North West - Haydock Research Ethics Committee
REC reference
17/NW/0105
Date of REC Opinion
28 Feb 2017
REC opinion
Favourable Opinion