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

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

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04273724
Enrollment
5
Registered
2020-02-18
Start date
2020-01-21
Completion date
2021-09-29
Last updated
2021-10-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bladder Cancer

Keywords

Geriatric oncology, Comprehensive geriatric assessment, Patient-reported outcomes, Muscle-invasive bladder cancer

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.

Interventions

OTHERTargeted 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.

Sponsors

UNC Lineberger Comprehensive Cancer Center
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Patient interest in impairment-directed interventions1 yearTo 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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026