Stage 0a Bladder Cancer AJCC v8, Stage 0is Bladder Cancer AJCC v8, Stage I Bladder Cancer AJCC v8, Stage II Bladder Cancer AJCC v8, Stage IIIA Bladder Cancer AJCC v8
Conditions
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.
Interventions
OTHERNon-Interventional Study
Non-Interventional Study
Sponsors
Mayo Clinic
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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". |
| 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORMark D. Tyson, M.D., M.P.H.
Mayo Clinic
Outcome results
None listed