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BRIEF TITLE: Early Intervention for Impairments Identified During Comprehensive Geriatric Assessment in Patients With Muscle-invasive Bladder Cancer

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


  • Org Study ID: LCCC 1946
  • Secondary ID:
  • NCT ID: NCT04273724
  • NCT Alias:
  • Sponsor: UNC Lineberger Comprehensive Cancer Center - Other
  • Source: 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.

Overal Status Start Date Phase Study Type
Recruiting January 21, 2020 N/A Interventional

Primary Outcomes:

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

Primary Outcome 1 - Time Frame: 1 year

Condition:

  • Bladder Cancer

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
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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: Chelsea Osterman, MD

Phone: 9849740000

Email: chelsea.osterman@unchealth.unc.edu

Location

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