Not provided
Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2024-00973 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| 18-004675 | Other Identifier | Mayo Clinic Institutional Review Board |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Observational | Patients complete surveys and also have their medical records reviewed on study. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Non-Interventional Study | Other | Non-Interventional Study |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Men and women diagnosed with clinically localized bladder cancer
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Mark D. Tyson, M.D., M.P.H. | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic in Arizona | Scottsdale | Arizona | 85259 | United States | ||
| Mayo Clinic in Florida |
Not provided
| Label | URL |
|---|---|
| Mayo Clinic Clinical Trials | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
| Jacksonville |
| Florida |
| 32224-9980 |
| United States |
| Mayo Clinic in Rochester | Rochester | Minnesota | 55905 | United States |
| ID | Term |
|---|---|
| D001749 | Urinary Bladder Neoplasms |
| ID | Term |
|---|---|
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |
Not provided
Not provided