Observational Study for Metastatic Bladder Cancer and Geriatric Assessments
This study is for people aged 65 and older with bladder cancer that has spread (metastatic) and cannot be removed by surgery (unresectable). It focuses on patients who cannot receive cisplatin chemotherapy. Researchers want to understand how different treatments affect your quality of life and side effects. They are using surveys like the Geriatric-8, National Comprehensive Cancer Network/Functional Assessment of Cancer Therapy Bladder Symptom Index-18 (FBISI-18), and Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE®) to learn more. The goal is to find the best ways to treat older patients with advanced bladder cancer who may have other health issues.
- Study design
- This is an observational study with about 180 participants. It is not testing a new drug but rather observing how current treatments impact patients.
- What's involved
- You would complete questionnaires over an expected period of up to 8 months.
- Compensation
- Not stated in the trial record.
- Follow-up
- The main study outcomes, like quality of life and side effects, are measured at 8 months.
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Management of Cisplatin-Ineligible Patients With Metastatic Bladder Cancer and The Role of Geriatric Assessments
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- Joaquim Bellmunt, MD, PhD · PRINCIPAL_INVESTIGATOR · Dana-Farber Cancer Institute
Who to contact
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Do you actually qualify for this trial?
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Inclusion
Exclusion
What this trial measures
- Quality of life in frail and at-risk patients with advanced bladder cancer deemed cisplatin-ineligible8 months
In frail and at-risk patients, as defined by geriatric-8 scores, will evaluate the difference in quality of life for participants receiving Carboplatin-based chemotherapy followed by immunotherapy maintenance versus Enfortumab Vedotin-Pembrolizumab. Quality of life will be measured by the National Comprehensive Cancer Network/Functional Assessment of Cancer Therapy Bladder Symptom Index-18 (NFBISI-18) version 2 questionnaire, a patient reported, eighteen question measure graded on a Likert scale.
- Patient reported adverse events in frail and at-risk patients with advanced bladder cancer deemed cisplatin-ineligible8 months
In frail and at-risk patients, as defined by geriatric-8 scores, will evaluate the difference in patient reported adverse events relevant to patients with bladder cancer between patients treated with Enfortumab Vedotin-Pembrolizumab vs. Carboplatin-based chemotherapy followed by immunotherapy maintenance. Patient reported adverse events will be assessed by the National Cancer Institute's Patient Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) questionnaire which will analyze 30 items, characterizing 16 symptomatic toxicities related treatment in terms of frequency, severity, interference (scoring from 0 to 4), and/or presence or absence (scoring 0 or 1).