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A Geriatric Assessment Intervention for Patients Aged 70 and Over Receiving Chemotherapy or Similar Agents for Advanced Cancer: Reducing Toxicity in Older Adults
This cluster randomized clinical trial compares a geriatric assessment intervention with usual care for reducing cancer treatment toxicity in older patients with cancer that has spread to other places in the body. A geriatric assessment may identify risk factors for cancer treatment toxicity and may improve outcomes for older patients with advanced cancer.
PRIMARY OBJECTIVES: I. To determine if providing information regarding geriatric assessment (GA) and GA-driven recommendations to oncology physicians reduces clinician-rated grade 3-5 toxicity in patients aged 70 and over with advanced cancer starting a new treatment regimen. SECONDARY OBJECTIVES: I. Proportion of patients who are alive at 6 months after study entry. II. Evaluate whether providing oncology physicians with information regarding GA summary and GA-driven recommendations influences clinical care of older patients receiving treatment for advanced cancer. IIA. Compare treatment decisions (as measured by relative dose intensity of the agents administered in the first cycle). IIB. Describe the number and type of GA-driven recommendations implemented for older patients starting a new treatment regimen for advanced cancer. OUTLINE: Treatment sites are randomized to 1 of 2 arms. ARM I (GA intervention): Patients complete a geriatric assessment. Patients and physicians are provided with the geriatric assessment information and recommendations. ARM II (usual care): Patients complete a geriatric assessment, but information other than clinically significant cognitive impairment and depression is not provided to the oncology teams. After completion of study, patients are followed up at 4-6 weeks, at 3 and 6 months, and at 1 year.
Age
70 - No limit years
Sex
ALL
Healthy Volunteers
No
City of Hope
Duarte, California, United States
Delaware/Christiana Care NCORP
Newark, Delaware, United States
Hawaii MU-NCORP
Honolulu, Hawaii, United States
University of Chicago
Chicago, Illinois, United States
Heartland NCORP
Decatur, Illinois, United States
Kansas City NCORP
Prairie Village, Kansas, United States
Wichita NCORP
Wichita, Kansas, United States
Gulf South MU-NCORP
New Orleans, Louisiana, United States
Cancer Research Consortium of West Michigan
Grand Rapids, Michigan, United States
Metro Minnesota NCORP
Minneapolis, Minnesota, United States
Start Date
July 29, 2014
Primary Completion Date
October 31, 2021
Completion Date
October 31, 2021
Last Updated
April 12, 2024
733
ACTUAL participants
Comprehensive Geriatric Assessment
OTHER
Quality-of-Life Assessment
OTHER
Survey Administration
OTHER
Lead Sponsor
Supriya Mohile
Collaborators
NCT05529069
NCT06337318
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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