This study evaluates the effect of bladder cancer treatment on quality of life.
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 Type
OBSERVATIONAL
Enrollment
704
Non-Interventional Study
Mayo Clinic in Arizona
Scottsdale, Arizona, United States
RECRUITINGMayo Clinic in Florida
Jacksonville, Florida, United States
RECRUITINGMayo Clinic in Rochester
Rochester, Minnesota, United States
RECRUITINGChange 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.
Time frame: 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".
Time frame: 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.
Time frame: At baseline, 6, 12, 24, and 36 months after treatment
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