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

Bladder Cancer Clinical Trial

Official title:

A Pilot Study of Early Intervention for Impairments Identified During Comprehensive Geriatric Assessment in Patients With Muscle-invasive Bladder Cancer

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04273724
• Other study ID #: LCCC 1946
• Status: Terminated
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Bladder Cancer
• Urinary Bladder Neoplasms

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