Superficial Bladder Cancer
Conditions
Keywords
NMIBC, non-muscle invasive bladder cancer, Patient reported outcome, Symptom burden, Questionnaire
Brief summary
This project will develop and evaluate a patient-reported symptom index to assess the impact of treatment for non-muscle invasive bladder cancer on patient burden, toxicity, symptoms and side effects. The symptom index will provide a method for assessing treatments from the patient's perspective; help healthcare professionals make better informed treatment decisions, and provide a method to be able to effectively evaluate treatments for non-muscle invasive bladder cancer.
Detailed description
The overarching aim of this research is to develop and evaluate a patient-reported Symptom Index (SI) for individuals with NMIBC (the NMIBC-SI) that is acceptable to patients, reliable, valid and responsive, and fit for purpose in clinical trials and clinical practice. Specific clinical aims: * Assess and compare key Patient-Reported Outcomes (PROs) across the full range of contemporary treatments for NMIBC, and over the disease trajectory including acute treatment and 1year survivorship; * Compare PROs between patients with low, intermediate, and high risk NMIBC. In field test 1, 200 participants will complete one questionnaire either in hard copy (pencil and paper) or online, at a time that is convenient for the participant. The questionnaire may take up to 20 minutes to complete. In field test 2, 250 participants will complete quality of life questionnaires at four different time points; 1) before tumour resection, 2) 1 week after resection, 3) 8 weeks after resection, and 4) 1 year after resection. The questionnaires can be completed in the clinic or at home, either in hard copy (pencil and paper) or online, at a time that is convenient for the participant but still within the relevant time point. The questionnaires may take up to 30 minutes to complete.
Interventions
None listed
Sponsors
Australian and New Zealand Urogenital and Prostate Cancer Trials Group
Cancer Australia
Cancer Council New South Wales
University of Sydney
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Field test 1: Inclusion Criteria: * diagnosed NMIBC * Adult (\>18yrs) * able to read and understand English * undergoing active treatment (i.e. one week after tumour resection or intravesical therapy) or completed final treatment for NMIBC within the last week
Exclusion criteria
* unconscious or confused * have cognitive impairment * unable to speak, read and/or write in English * diagnosed with muscle invasive disease * unable to provide informed consent Field test 2: Inclusion Criteria: * newly diagnosed NMIBC * Adult (\>18yrs) * able to read and understand English * after imaging or flexible cystoscopy, and before active treatment * either before endoscopic resection, or more than 4 weeks since endoscopic resection, but before active/ongoing treatment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| NMIBC-SI development and validation | Field test 1: once only (cross-sectional). Field test 2: baseline to post-treatment (longitudinal) | non-muscle invasive bladder cancer symptom index (questionnaire being developed and evaluated in this study) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| QLQC-30 | Field test 2: four time-points over 1 year | EORTC cancer quality of life questionnaire |
| NMIBC24 | Field test 2: four time-points over 1 year | EORTC superficial bladder cancer questionnaire |
| NMIBC-SI long term | Field test 2: four time-points over 1 year | non-muscle invasive bladder cancer symptom index (long-term follow-up, and differences between groups) |
Countries
Australia, Canada, New Zealand, United Kingdom, United States
Outcome results
None listed