Background
Methods/design
Aims
Study design
Study setting
Participants
Inclusion Criteria | Exclusion Criteria |
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1. Adult 18 years of age or older; and 2. Presenting with high-grade NMIBC established by anatomic pathology as tumor stage classification Tis, Ta, or T1, and with: a. Pathology documentation from any hospital/clinic/medical center, and b. More than 50% urothelial carcinoma component in the specimen; and 3. History of high-grade NMIBC established by anatomic pathology as tumor stage classification Tis, Ta, or T1; and 4. Attempted or received induction BCG (at least 3 out of 6 instillations) at any point in time; and 5. In the previous 12 months, received at least one instillation of any intravesical agent (induction or maintenance) or one administration of systemic therapy for NMIBC treatment | 1. Any plasmacytoid or small cell (neuroendocrine) component in the pathology (past or current presentation); 2. Previous history of cystectomy or radiation therapy for bladder cancer; 3. Previous history of muscle-invasive bladder cancer or metastatic bladder cancer; 4. Any history of upper tract urothelial carcinoma; 5. Incarcerated in a detention facility or in police custody (patients wearing a monitoring device can be enrolled) at baseline/screening; 6. Contraindication to radical cystectomy (e.g., ASA classification of 4, cancer does not warrant consideration of cystectomy); 7. Contraindication to medical therapy (i.e., intolerant of all medical therapies); 8. Unable to provide written informed consent in English; 9. Unable to be contacted for research surveys; 10. Planning to participate in a Phase I or Phase II interventional clinical trial for NMIBC (unless in the control/comparator arm of a Phase II trial) or any blinded interventional trial for NMIBC |
Category | Definition |
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1a. BCG Unresponsive | Persistent or recurrent high-grade NMIBC (stage Tis, Ta, or T1) determined at 6-month evaluation. Patient must have had 5 out of 6 induction BCG instillations and 2 out of 3 maintenance BCG instillations |
1b. BCG Unresponsivea | Any stage progression at 3-month evaluation despite 5 out of 6 induction BCG instillations |
2. Relapsing | Recurrent high-grade NMIBC more than 6 months after diagnosis. Patient must have had at least 3 out of 6 induction BCG instillations and had a maintenance BCG instillation within the last 6 months |
3. No recent BCGa | Had at least 3 of 6 induction BCG instillations at any point in time. Must have had at least one instillation of some type of intravesical agent (induction or maintenance; postop instillation does not apply) or one administration of systemic therapy approved for NMIBC treatment in last 12 months |
Recruitment and retention
Interventions
Comparisons
Name of Outcome | Specific Measure | Timepoints (months)c |
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Physical functioning | EORTC QLQ-C30 [22] physical functioning domain | 3, 6, 9, 12a |
Health-related QOL | EORTC QLQ-C30 [22] | 3, 6, 9, 12b |
Bladder cancer-specific QOL | Bladder Cancer Index [25] | 3, 6, 9, 12b |
Financial toxicity | Comprehensive Score for Financial Toxicity (COST) measure | 12b |
Decision regret | 12b | |
Anxiety & depression | PROMIS-29 anxiety & depression domains [26] | 3, 6, 9, 12b |
Generic QOL/Global utility | EQ-5D-5L [24] | 12b |
Cancer-specific survival | EHR abstraction for mortality events and cause of death | 12b |
Progression-free survival | EHR abstraction for progression to muscle-invasive or radiographic evidence of metastatic bladder cancer | 12b |
Health care utilization | Extra clinic visits, ED visits, home health care | 12b |
Health state preferences | Time tradeoff (TTO) questions | 12b |