Quality of Life After Treatment for Bladder Cancer: The Bladder Cancer Survivorship Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Mayo Clinic
- Enrollment
- 204
- Locations
- 6
- Primary Endpoint
- Change in quality of life outcomes - PROMIS-29
Study Overview
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 Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Observational
Patients complete surveys and also have their medical records reviewed on study.
Intervention: Non-Interventional Study (Other)
Outcomes
Primary Outcomes
Change in quality of life outcomes - PROMIS-29
Time Frame: 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
Time Frame: 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
Time Frame: 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".
Secondary Outcomes
No secondary outcomes reported