Quality of Life After Treatment for Bladder Cancer: The Bladder Cancer Survivorship Study
2 other identifiers
observational
204
1 country
3
Brief Summary
This study evaluates the effect of bladder cancer treatment on quality of life.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Oct 2018
Longer than P75 for all trials
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 12, 2018
CompletedFirst Submitted
Initial submission to the registry
April 2, 2024
CompletedFirst Posted
Study publicly available on registry
April 5, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 31, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
January 31, 2029
April 17, 2026
April 1, 2026
10.3 years
April 2, 2024
April 14, 2026
Conditions
Outcome Measures
Primary Outcomes (3)
Change in quality of life outcomes - PROMIS-29
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.
At baseline, 6, 12, 24, and 36 months
Change in quality of life outcomes - Bladder Cancer Index
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".
At baseline, 6, 12, 24, and 36 months
Patient level characteristics
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.
At baseline, 6, 12, 24, and 36 months after treatment
Study Arms (1)
Observational
Patients complete surveys and also have their medical records reviewed on study.
Interventions
Eligibility Criteria
Men and women diagnosed with clinically localized bladder cancer
You may qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Mayo Cliniclead
Study Sites (3)
Mayo Clinic in Arizona
Scottsdale, Arizona, 85259, United States
Mayo Clinic in Florida
Jacksonville, Florida, 32224-9980, United States
Mayo Clinic in Rochester
Rochester, Minnesota, 55905, United States
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Mark D. Tyson, M.D., M.P.H.
Mayo Clinic
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 2, 2024
First Posted
April 5, 2024
Study Start
October 12, 2018
Primary Completion (Estimated)
January 31, 2029
Study Completion (Estimated)
January 31, 2029
Last Updated
April 17, 2026
Record last verified: 2026-04