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Brief Title: 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

INTRODUCTION

  • Org Study ID: LCCC 1946
  • Secondary ID: N/A
  • NTC ID: NCT04273724
  • Sponsor: UNC Lineberger Comprehensive Cancer Center

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.

  • Overall Status
    Recruiting
  • Start Date
    January 21, 2020
  • Phase
    Not Applicable
  • Study Type
    Interventional

PRIMARY OUTCOMES

Primary Outcome 1 - Measure: Patient interest in impairment-directed interventions

Primary Outcome 1 - Timeframe: 1 year

CONDITION

  • Bladder Cancer

ELIGIBILITY

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

Gender: All

Minimum Age: 65 Years

Maximum Age: N/A

Healthy Volunteers: No

OFFICIAL INFORMATION

Name: Hyman Muss, MD

Role: Principal Investigator

Affiliation: University of North Carolina, Chapel Hill

Overall Contact

Name: Hyman Muss, MD

Phone: 9849740000

Email: chelsea.osterman@unchealth.unc.edu

LOCATION

Facility Status Contact
Facility: Lineberger Comprehensive Cancer Center at University of North Carolina, Chapel Hill
Chapel Hill, North Carolina 27599
United States
Status: Recruiting Contact: Contact
Chelsea Osterman, MD
984-974-0000
chelsea.osterman@unchealth.unc.edu