BRAVO Study 1: beliefs about bladder cancer treatments

Full title BRAVO study 1: High grade Bladder cancer: A randomised controlled trial of Radical Cystectomy against intra-vesical immunotherapy. Understanding patients’ and health professionals’ beliefs about the two interventions and potential barriers to recruitment
Research type Research study
IRAS ID 189660
Contact Name Maureen Twiddy
Contact Email m.twiddy@leeds.ac.uk
Sponsor organisation Sheffield Teaching Hospitals NHS Foundation Trust
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Research summary High-risk non-muscle invasive bladder cancer is an unpredictable disease. Whilst 25% of tumours progress to invasion, the majority do not. Treatment is either BCG immunotherapy (mBCG involves 27 intravesical instillations and 10 cystoscopies over 3 years) or primary cystectomy (removal of bladder). We have funding for a feasibility trial comparing these two treatments. However, a similar study funded by Cancer Research (SPARE trial) failed to recruit. This was for a number of reasons, but partly because they did not consider the how best to present the study information to patients. We have been given funding to undertake a 12 month qualitative study before we run the clinical trial (due to start at the end of 2016) to try to find solutions to the problems faced by the SPARE trial. We will recruit bladder cancer patients (up to 24) and staff (up to 24) from bladder cancer treatment centres across Yorkshire and Humber (and Newcastle). Patients will be eligible providing they are no more than 24 months post diagnosis. We will recruit patients who have experience of either of the two treatments. We will use interviews and focus groups (group discussions) to find out what patients and staff believe about the two treatments, what they think the barriers to participation might be, and work with them to find solutions to these challenges. The new knowledge we generate in this study will be used to develop a training package and training materials for staff. The materials we develop will be used to help the recruiters work with patients to make an informed decision about participation in the planned randomised controlled trial. It will also be used as a basis for the information given to patients.
REC Name London - City & East Research Ethics Committee
REC Reference 15/LO/1864
REC Opinion

Favourable Opinion

Favourable Opinion

Date of REC Opinion 19 October 2015