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Trial record 2 of 187 for:    Recruiting, Enrolling by invitation Studies | Bladder Cancer | United States

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

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ClinicalTrials.gov Identifier: NCT04273724
Recruitment Status : Recruiting
First Posted : February 18, 2020
Last Update Posted : August 7, 2020
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Bladder Cancer Other: Targeted Interventions for Impairments Identified During Geriatric Assessment Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: A Pilot Study of Early Intervention for Impairments Identified During Comprehensive Geriatric Assessment in Patients With Muscle-invasive Bladder Cancer
Actual Study Start Date : January 21, 2020
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Geriatric assessment guided interventions Other: Targeted Interventions for Impairments Identified During Geriatric Assessment
Participants will be referred for specific evidence-based interventions based on impairments identified during a baseline comprehensive geriatric assessment.




Primary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04273724


Contacts
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Contact: Chelsea Osterman, MD 9849740000 chelsea.osterman@unchealth.unc.edu

Locations
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United States, North Carolina
Lineberger Comprehensive Cancer Center at University of North Carolina, Chapel Hill Recruiting
Chapel Hill, North Carolina, United States, 27599
Contact: Chelsea Osterman, MD    984-974-0000    chelsea.osterman@unchealth.unc.edu   
Principal Investigator: Hyman Muss, MD         
Sub-Investigator: Chelsea Osterman, MD         
Sub-Investigator: Kirsten Nyrop, PhD         
Sub-Investigator: Matthew Milowsky, MD         
Sponsors and Collaborators
UNC Lineberger Comprehensive Cancer Center
Investigators
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Principal Investigator: Hyman Muss, MD University of North Carolina, Chapel Hill
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Responsible Party: UNC Lineberger Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT04273724    
Other Study ID Numbers: LCCC 1946
First Posted: February 18, 2020    Key Record Dates
Last Update Posted: August 7, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by UNC Lineberger Comprehensive Cancer Center:
Geriatric oncology
Comprehensive geriatric assessment
Patient-reported outcomes
Muscle-invasive bladder cancer
Additional relevant MeSH terms:
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Urinary Bladder Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Urinary Bladder Diseases
Urologic Diseases