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

NCT ID: NCT04273724

Last Updated: 2021-10-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

5 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-21

Study Completion Date

2021-09-29

Brief Summary

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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

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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.

Conditions

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Bladder Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Geriatric assessment guided interventions

Group Type EXPERIMENTAL

Targeted Interventions for Impairments Identified During Geriatric Assessment

Intervention Type OTHER

Participants will be referred for specific evidence-based interventions based on impairments identified during a baseline comprehensive geriatric assessment.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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UNC Lineberger Comprehensive Cancer Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Hyman Muss, MD

Role: PRINCIPAL_INVESTIGATOR

University of North Carolina, Chapel Hill

Locations

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Lineberger Comprehensive Cancer Center at University of North Carolina, Chapel Hill

Chapel Hill, North Carolina, United States

Site Status

Countries

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United States

Other Identifiers

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LCCC 1946

Identifier Type: -

Identifier Source: org_study_id