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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT04273724
Other study ID # LCCC 1946
Secondary ID
Status Terminated
Phase N/A
First received
Last updated
Start date January 21, 2020
Est. completion date September 29, 2021

Study information

Verified date October 2021
Source UNC Lineberger Comprehensive Cancer Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

A Comprehensive Geriatric Assessment (CGA) is a set of tests used to evaluate a patient's medical, social, and functional status, and can identify impairments in these domains that may not be noticed otherwise. Prior studies have shown that a CGA can accurately predict which patients are more likely to have serious side effects from cancer treatment. However, it is unknown whether interventions can be done to address the impairments found during a CGA in order to reduce the risk of these side effects. This pilot study will test the feasibility of targeted interventions for deficits identified during a CGA in patients 65 years or older with bladder cancer that have not yet started treatment.


Description:

This study will enroll patients with muscle-invasive bladder cancer that have not yet started systemic cancer treatment. The participants will complete a CGA and patient-reported outcome (PRO) measures at baseline. Based on any impairments found during the CGA, participants will be referred to specialists to help address these difficulties. Participants will complete the CGA and PRO measures again at 3 months and 1 year after the initial assessment. The goal of this study is to see if patients with advanced bladder cancer are interested in referrals to specialists to address their impairments, and whether participants attend those appointments.


Recruitment information / eligibility

Status Terminated
Enrollment 5
Est. completion date September 29, 2021
Est. primary completion date September 29, 2021
Accepts healthy volunteers No
Gender All
Age group 65 Years and older
Eligibility Inclusion Criteria: - Age 65 years or older - Confirmed diagnosis of muscle-invasive bladder cancer - Plan to undergo systemic treatment but have not yet started therapy Exclusion Criteria: - Must be able to read English

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Targeted Interventions for Impairments Identified During Geriatric Assessment
Participants will be referred for specific evidence-based interventions based on impairments identified during a baseline comprehensive geriatric assessment.

Locations

Country Name City State
United States Lineberger Comprehensive Cancer Center at University of North Carolina, Chapel Hill Chapel Hill North Carolina

Sponsors (1)

Lead Sponsor Collaborator
UNC Lineberger Comprehensive Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Patient interest in impairment-directed interventions To establish patient interest in referral for interventions based on impairments found during geriatric assessment within an outpatient genitourinary oncology clinic. Success will be at least 75% of patients accepting referral for indicated interventions. 1 year
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