RECRUITINGOBSERVATIONAL

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

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - Age ≥65-years-old (study will limit total enrollment of patients between ages 65-70 to 20% of the total study population) - Unresectable or metastatic bladder cancer with histologically proven urothelial carcinoma. Any component of variant histology is allowed - Cisplatin-ineligible as determined by the subject's primary oncologist - Receiving treatment with chemotherapy (+/- immunotherapy maintenance), enfortumab vedotin-pembrolizumab combination therapy or immunotherapy alone - Ability to understand and the willingness to sign a written willing to sign a consent form document and to complete patient reported outcomes that will be in English or Spanish either alone or with assistance of study researcher or family Who Should NOT Join This Trial: - Subjects who elect to not undergo cancer-directed therapy - Subjects obtaining their care outside of DFCI or DFCI affiliate sites - Advanced cognitive impairment or inability to complete surveys - Participants who are receiving any other investigational agents for this condition (if appropriate only). Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

Inclusion Criteria: * Age ≥65-years-old (study will limit total enrollment of patients between ages 65-70 to 20% of the total study population) * Unresectable or metastatic bladder cancer with histologically proven urothelial carcinoma. Any component of variant histology is allowed * Cisplatin-ineligible as determined by the subject's primary oncologist * Receiving treatment with chemotherapy (+/- immunotherapy maintenance), enfortumab vedotin-pembrolizumab combination therapy or immunotherapy alone * Ability to understand and the willingness to sign a written informed consent document and to complete patient reported outcomes that will be in English or Spanish either alone or with assistance of study researcher or family Exclusion Criteria: * Subjects who elect to not undergo cancer-directed therapy * Subjects obtaining their care outside of DFCI or DFCI affiliate sites * Advanced cognitive impairment or inability to complete surveys * Participants who are receiving any other investigational agents for this condition (if appropriate only).

Treatments Being Tested

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