Quality of Life After Treatment for Bladder Cancer: The Bladder Cancer Survivorship Study

Stage IIIA Bladder Cancer AJCC v8 Clinical Trial

Official title:

Quality of Life After Treatment for Bladder Cancer: The Bladder Cancer Survivorship Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06350734
• Other study ID #: 18-004675
• Secondary ID: NCI-2024-0097318
• Status: Recruiting
• Start date: October 12, 2018
• Est. completion date: January 31, 2029

Study information

• Verified date: April 2024
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This study evaluates the effect of bladder cancer treatment on quality of life.

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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• 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
• Urinary Bladder Neoplasms

Intervention

Other:
• Non-Interventional Study
Non-Interventional Study

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

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