Table 3.
The CISTO Study primary and secondary outcomes
| Name of Outcome | Specific Measure | Timepoints (months)c |
|---|---|---|
| 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 | Decision regret [27, 28] | 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 |
QOL Quality of life, EORTC QLQ-C30 European Organisation for Research and Treatment of Cancer Core Quality of Life, PROMIS Patient Reported Outcome Measurement Information System, EHR Electronic health record, ED Emergency Department
aIndicates primary outcome
bIndicates secondary outcomes
cThis study will allow for the collection of 12 months of follow up for all participants. Additional surveys are administered every 6 months thereafter up to 48 months depending on study enrollment date