Stage IIIA Bladder Cancer AJCC v8 Clinical Trial
Official title:
Quality of Life After Treatment for Bladder Cancer: The Bladder Cancer Survivorship Study
Verified date | April 2024 |
Source | Mayo Clinic |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
This study evaluates the effect of bladder cancer treatment on quality of life.
Status | Recruiting |
Enrollment | 704 |
Est. completion date | January 31, 2029 |
Est. primary completion date | January 31, 2029 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Mayo Clinic in Florida | Jacksonville | Florida |
United States | Mayo Clinic in Rochester | Rochester | Minnesota |
United States | Mayo Clinic in Arizona | Scottsdale | Arizona |
Lead Sponsor | Collaborator |
---|---|
Mayo Clinic |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | |
Primary | 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 |
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