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

Primary Purpose

Bladder Cancer

Status

Terminated

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Targeted Interventions for Impairments Identified During Geriatric Assessment

About this trial

This is an interventional supportive care trial for Bladder Cancer focused on measuring Geriatric oncology, Comprehensive geriatric assessment, Patient-reported outcomes, Muscle-invasive bladder cancer

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Geriatric assessment guided interventions

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT04273724

First Posted

February 5, 2020

Last Updated

October 15, 2021

Sponsor

UNC Lineberger Comprehensive Cancer Center

1. Study Identification

Unique Protocol Identification Number

NCT04273724

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2021

Overall Recruitment Status

Terminated

Why Stopped

Investigator left and research was discontinued.

Study Start Date

January 21, 2020 (Actual)

Primary Completion Date

September 29, 2021 (Actual)

Study Completion Date

September 29, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

UNC Lineberger Comprehensive Cancer Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Bladder Cancer

Keywords

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

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

5 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Geriatric assessment guided interventions

Arm Type

Experimental

Intervention Type

Other

Intervention Name(s)

Targeted Interventions for Impairments Identified During Geriatric Assessment

Intervention Description

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

Primary Outcome Measure Information:

Title

Patient interest in impairment-directed interventions

Description

Time Frame

1 year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Hyman Muss, MD

Organizational Affiliation

University of North Carolina, Chapel Hill

Official's Role

Principal Investigator

Facility Information:

Facility Name

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

City

Chapel Hill

State/Province

North Carolina

ZIP/Postal Code

27599

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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