(UroToday.com) The 2023 American Urological Association (AUA) annual meeting held in Chicago, IL between April 28 and May 1st, 2023, was host to a non-invasive bladder cancer moderated poster session. Dr. John Gore presented the framework and early survey completion outcomes for Comparison of Intravesical Therapy and Surgery as Treatment Options for Recurrent Bladder Cancer (CISTO): Collection of Patient-Reported Outcomes.
Patients with recurrent non-muscle invasive bladder cancer (NMIBC), particularly those with high-risk disease and prior failed intravesical therapy, have to weigh the risk of cancer progression and potential loss of the curative window with continued conservative management against the risk of morbidity and loss of quality of life (QoL) with radical cystectomy. The pragmatic CISTO Study (NCT03933826) includes the collection of patient-reported outcomes to aid future patients with this treatment decision.
This study will enroll 572 patients who will complete baseline and follow-up surveys every quarter for up to four years. To ensure maximal potential compliance, the centralized collection of follow-up surveys utilizes several modalities for contacting participants (email, mail, phone, text) as well as completing surveys (paper, online).
Baseline and follow-up surveys will assess:
- QoL and physical functioning using the EORTC QLQ-C30
- Urinary, sexual, and bowel function using the Bladder Cancer Index (BCI)
- Financial distress using the Comprehensive Score for Financial Toxicity, COST
- Anxiety and depression using PROMIS
- Generic QoL using EQ5D
Additionally, follow-up surveys will assess healthcare utilization and decision regret.
As of time of reporting, 337 participants have been enrolled. The completion rate for the primary endpoint of QoL at 12 months was 93%. Among returned surveys, the overall rate of missingness at baseline and 12 months was low (<5%) and there was no evidence of survey fatigue. The highest missingness rate was present for BCI (4% and 7%, respectively). The ten items with the highest missingness rates were in the BCI sexual function domain (8-13% and 11-18%, respectively).
The authors concluded that based on the current high rate of survey completion, the CISTO Study will be powered to compare outcomes across a variety of domains, including QoL, urinary function, and anxiety. The low completion rate of questions relating to sexual function makes it unlikely that this study will yield valid and/or generalizable results in this specific domain. This, in combination with anecdotal evidence that participants find these questions upsetting, even when optional and confusing, as there is no place to indicate that the questions do not apply if they are not sexually active, highlights the difficulty in researching this intensely personal outcome.
Presented by: John Gore, MD, MS, Professor, Department of Urology, University of Washington, Seattle, WA
Written by: Rashid K. Sayyid, MD, MSc – Society of Urologic Oncology (SUO) Clinical Fellow at The University of Toronto, @rksayyid on Twitter during the 2023 American Urological Association (AUA) Annual Meeting, Chicago, IL, April 27 – May 1, 2023