<--> SHORE-C: Sussex Health Outcomes Research and Education in Cancer

Quality of Life After Bladder Cancer (Q-ABC): A comparison of patient related outcomes following radical surgery or radiotherapy

More Information

The objectives of the Q-ABC study are: to carry out a prospective non randomised multi-centre comparison of quality of life outcomes between patients treated with radical surgery and radical radiotherapy for muscle invasive bladder cancer. A health economic evaluation incorporating patient reported socio-economic impact data will also be conducted as a sub-study.

Eligible patients will be identified from urology multi-disciplinary team meetings and uro-oncology clinics at participating centres. Designated members of the treatment teams will recruit and consent patients.

Assessments will take place at:

  • baseline prior to the start of treatment in clinic with a research nurse. The research nurse will complete a paper clinical report form (CRF) gathering demographic, clinical and treatment information from the participant’s hospital medical records. All other patient reported outcomes measures (PROMs) will be administered by post
  • (second “baseline”) the end of neo-adjuvant chemotherapy if given as part of treatment
  • 6, 12 & 24 months from the start of definitive treatment

Data collection will involve:

  • a quality of life questionnaire (FACT-BL)
  • a Fear of Recurrence scale (FOR, Kornblith)
  • the health outcome questionnaire (EQ-5D-5L) used for health economic evaluation and to establish quality adjusted life years (QALYS)
  • research nurses at each centre collecting clinical follow up data and cancer specific outcomes with regard to local and distant recurrence rates and timings of check cystoscopies and re-staging imaging (if any). Gastrointestinal and urinary toxicity rates using CTCAE v4 will be collected for all participants at one year post treatment by the research nurse either face-to-face with the patient or by phone

Study Management

The recruitment target is n=376 and this is a collaborative undertaking between Brighton and Sussex University Hospitals NHS Trust (BSUH) (collecting clinical outcomes), SHORE-C (collecting QoL data), and the University of Surrey (conducting a health economic evaluation). Recruitment is ongoing and study end is March’22.

^ Top