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RECRUITING
NCT06138561

Management of Cisplatin-Ineligible Patients With Metastatic Bladder Cancer and The Role of Geriatric Assessments

Sponsor: Dana-Farber Cancer Institute

View on ClinicalTrials.gov

Summary

The goal of this study is to better understand how to best treat participants with advanced bladder cancer who may not be able to tolerate all of the chemotherapy drugs that have been shown to be effective. In this study, investigators are assessing the role of the survey, the Geriatric-8, and its ability to predict outcomes in older participants undergoing cancer treatments. Additionally, investigators are evaluating the differential impact of treatments on quality of life in an older and at risk population.

Key Details

Gender

All

Age Range

65 Years - Any

Study Type

OBSERVATIONAL

Enrollment

180

Start Date

2024-03-05

Completion Date

2028-01-01

Last Updated

2026-02-17

Healthy Volunteers

No

Interventions

BEHAVIORAL

Geriatric-8 Survey

A screening tool to evaluate frailty and at-risk participants by covering multiple domains that contribute to frailty, including mobility, functional status, pharmacologic burden, and underlying psychologic burden. A total score ranges from 0 to 17 with participants scoring \> 14 points are more likely to be fit, or having a better health status, while those scoring 0 - 14 would benefit from further comprehensive geriatric assessment.

BEHAVIORAL

National Comprehensive Cancer Network/Functional Assessment of Cancer Therapy Bladder Symptom Index-18 (FBISI-18)

Patient reported, sixteen question survey focused on evaluation of quality of life in patients with bladder cancer.

BEHAVIORAL

Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE®)

Patient-reported questionnaire that evaluates cancer-specific toxicity, developed based upon Common Terminology Criteria for Adverse Events.

Locations (1)

Dana-Farber Cancer Institute

Boston, Massachusetts, United States