Early Intervention for Impairments Identified During Comprehensive Geriatric Assessment in Patients With Bladder Cancer

Not Applicable

Terminated

• Conditions: Bladder Cancer
• Interventions: Other: Targeted Interventions for Impairments Identified During Geriatric Assessment

• Registration Number: NCT04273724
• Lead Sponsor: UNC Lineberger Comprehensive Cancer Center

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2020-01-21
• Study First Submitted: 2020-02-05
• Study First Submitted QC: 2020-02-13
• Study First Posted: 2020-02-18
• Primary Completion: 2021-09-29
• Study Completion: 2021-09-29
• Status Verified: 2021-10
• Last Update Submitted: 2021-10-15
• Last Update Posted: 2021-10-18

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 5

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Geriatric assessment guided interventions	Targeted Interventions for Impairments Identified During Geriatric Assessment	-

Primary Outcome Measures

Name	Time	Method
Patient interest in impairment-directed interventions	1 year	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.

Trial Locations

Locations (1)

Lineberger Comprehensive Cancer Center at University of North Carolina, Chapel Hill; 🇺🇸 Chapel Hill, North Carolina, United States