Skip to main content
Clinical Trials/NCT04273724
NCT04273724
Terminated
N/A

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

UNC Lineberger Comprehensive Cancer Center1 site in 1 country5 target enrollmentJanuary 21, 2020
ConditionsBladder Cancer

Overview

Phase
N/A
Intervention
Not specified
Conditions
Bladder Cancer
Sponsor
UNC Lineberger Comprehensive Cancer Center
Enrollment
5
Locations
1
Primary Endpoint
Patient interest in impairment-directed interventions
Status
Terminated
Last Updated
4 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 21, 2020
End Date
September 29, 2021
Last Updated
4 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Patient interest in impairment-directed interventions

Time Frame: 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.

Study Sites (1)

Loading locations...

Similar Trials