Bladder cancer Cancer
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Aged = 16 years, no upper age limit 2. Any patient undergoing potentially curative radical treatments for confirmed muscle invasive bladder cancer by either surgery or radiotherapy 3. Willing to provide informed consent 4. English Language competence sufficient to complete questionnaires
Exclusion criteria
Exclusion criteria: 1. Prior pelvic radiotherapy or surgery 2. Patients with bladder cancer other than transitional cell carcinoma 3. Patients who, in the judgement of the local PI, are not suitable for the study due to significant mental health disorders or cognitive impairment 4. Previous malignancy in the last 5 years except for: non-muscle invasive bladder cancer; non-melanoma skin cancer, CIS of cervix or LCIS of breast
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Quality of life is measured by the EQ-5D-5L and the FACT-Bl questionnaires at baseline, 6, 12 and 24 months | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Participant characteristics measured using the study specific CRF which includes demographic information, cancer staging, 6 items from the CTCAE V5.0 and Charlson comorbidity index at baseline 2. Fear of recurrence measured using Kornblith fear of recurrence questionnaire at baseline, 12 and 24 months 3. Survival and recurrence rates measured via follow-up CRFs at 12 and 24 months 4. Clinician graded toxicity measured by a 5-item CTCAE V5.0 and patient reported toxicity via specific items on the FACT-Bl questionnaire at 12 months 5. Costs calculated from hospital use (from CRF data about treatment and follow-up) and patient-reported costs via the UK Cancer Costs questionnaire completed at baseline and 3 monthly for the first year | — |
Countries
England, United Kingdom