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

NCT04273724 | Terminated DMC

• 1 other identifier: LCCC 1946
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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.

Conditions

Bladder Cancer

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Geriatric assessment guided interventions

EXPERIMENTAL

Other: Targeted Interventions for Impairments Identified During Geriatric Assessment

Interventions

Targeted Interventions for Impairments Identified During Geriatric Assessment OTHER

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

Geriatric assessment guided interventions

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Age 65 years or older
• Confirmed diagnosis of muscle-invasive bladder cancer
• Plan to undergo systemic treatment but have not yet started therapy

You may not qualify if:

• Must be able to read English

Sponsors & Collaborators

• UNC Lineberger Comprehensive Cancer Center: lead

Study Sites (1)

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

Chapel Hill, North Carolina, 27599, United States

Location

MeSH Terms

Conditions

Urinary Bladder Neoplasms

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases

Study Officials

• Hyman Muss, MD

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 5, 2020
• First Posted: February 18, 2020
• Study Start: January 21, 2020
• Primary Completion: September 29, 2021
• Study Completion: September 29, 2021
• Last Updated: October 18, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)