Quality of Life After Treatment for Bladder Cancer: The Bladder Cancer Survivorship Study

Recruiting

• Conditions: Stage 0is Bladder Cancer AJCC v8; Stage II Bladder Cancer AJCC v8; Stage 0a Bladder Cancer AJCC v8; Stage I Bladder Cancer AJCC v8; Stage IIIA Bladder Cancer AJCC v8
• Interventions: Other: Non-Interventional Study

• Registration Number: NCT06350734
• Lead Sponsor: Mayo Clinic

Brief Summary

This study evaluates the effect of bladder cancer treatment on quality of life.

Detailed Description

PRIMARY OBJECTIVES:

I. To compare general and disease-specific quality of life outcomes at 6, 12, 24, and 36 months after treatment for localized bladder cancer using the PROMIS-29 and the Bladder Cancer Index (BCI) respectively.

II. To identify patient level characteristics that may influence quality of life outcomes after treatment for localized bladder cancer.

OUTLINE: This is an observational study.

Patients complete surveys and also have their medical records reviewed on study.

Study Timeline

• Study Start: 2018-10-12
• Study First Submitted: 2024-04-02
• Study First Submitted QC: 2024-04-02
• Study First Posted: 2024-04-05
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-15
• Last Update Posted: 2025-05-18
• Primary Completion: 2029-01-31
• Study Completion: 2029-01-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 704

Inclusion Criteria

• Have pathologically confirmed, clinically localized, bladder cancer
• Be willing to complete a survey in English before starting definitive treatment (surgery or radiation);
• Able to give consent.

Exclusion Criteria

• Does not meet inclusion criteria

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Observational	Non-Interventional Study	Patients complete surveys and also have their medical records reviewed on study.

Primary Outcome Measures

Name	Time	Method
Change in quality of life outcomes - PROMIS-29	At baseline, 6, 12, 24, and 36 months	Assessed using the Patient-Reported Outcomes Measurement Information System (PROMIS)-29, a 29-item instrument with 29 questions in eight categories of Health Related Quality of Life (HRQOL): physical function, sleep disturbance, pain interference and pain intensity, fatigue, anxiety, depression) and ability to participate in social roles and activities. Questions are answered on a 5-point scale with varying responses assigned to the scale based on the category/question.
Patient level characteristics	At baseline, 6, 12, 24, and 36 months after treatment	Will be assessed by the effect of race/ethnicity, comorbid conditions, education level, gender, and age on patient reported outcomes. Interactions between intervention type and patient-level characteristics will be included. The distributions of variables will be summarized graphically and numerically.
Change in quality of life outcomes - Bladder Cancer Index	At baseline, 6, 12, 24, and 36 months	Assessed using the Bladder Cancer Index (BCI). The BCI consists of 36 items, with 4- or 5-point Likert response scales for each item, covering 3 primary domains: urinary (14 items), bowel (10 items), and sexual (12 items). The items focus on the frequency of the disease symptoms, with answer scales such as: "Never, rarely, about half the time, usually, or always".

Trial Locations

Locations (3)

Mayo Clinic in Florida; 🇺🇸 Jacksonville, Florida, United States

Mayo Clinic in Arizona; 🇺🇸 Scottsdale, Arizona, United States

Mayo Clinic in Rochester; 🇺🇸 Rochester, Minnesota, United States