Randomised Phase II/III Clinical Study of a Non-Investigational Medicinal Product

Open label, multi-stage randomised controlled study with three overlapping stages: feasibility, intermediate and final efficacy stage.

The qualitative sub study extends throughout all phases of the Bladder path study. It aims is to understand patients’, their partners’, relatives’ or friends’ views and experience of the BladderPath trial and those of healthcare professionals of the study and the new pathway over time.

The study aims to:

• Explore the recruitment process and its acceptability to patients and healthcare professional, particularly at a sensitive time when patients are recruited immediately following the delivery of bad news.
• Investigate patients’ experiences of the recruitment process and their decision-making regarding participation.
• Explore possible sources of recruitment bias.
• Investigate the views of patients, their partners, relatives or friends regarding their participation in the trial and whether their experiences match the expectations they had at the outset.

Funded by

 NIHR Health Technology Assessment (HTA)

Research team members

Dr Veronica Nanton – Senior Research Fellow - Warwick

Julia Roscoe – Research Associate - Warwick

Collaborators

BladderPath study team based at Cancer Research UK Clinical Trials Unit (CRCTU), Institute of Genomic & Cancer Sciences, University of Birmingham

Chief Investigator - Professor Nicholas James

Ana Hughes - Senior Trial Coordinator

Ann Pope – Trial Coordinator Cancer Research UK Clinical Trials Unit

Dates

Sept 2019 – Nov 2020

Links

Bladderpath - University of Birmingham