Evaluation of Geriatric Assessment and Management for Older Adults With Non-small Cell Lung Cancer Receiving Chemotherapy Radiation Therapy

Part of paid clinical trials in Duarte, California.

Sponsor
City of Hope Medical Center
Study ID
NCT06139627
Status
Recruiting

Conditions

  • Lung Non-Small Cell Carcinoma
  • Stage III Lung Cancer AJCC v8

Eligibility Criteria

Sex
ALL
Age
60 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Best Practice — OTHER
    Receive usual care
  • Biospecimen Collection — PROCEDURE
    Undergo blood and stool sample collection
  • Communication Intervention — OTHER
    Receive GA assessment summary and assessment-based recommendations
  • Comprehensive Geriatric Assessment — OTHER
    Complete GA
  • Electronic Health Record Review — OTHER
    Ancillary studies
  • Survey Administration — OTHER
    Ancillary studies

Study Details

This clinical trial tests how well a geriatric assessment (GA) with GA-directed treatment recommendations, compared to GA with usual care, works in identifying risk factors, reducing chemotherapy radiation toxicity and functional decline, and improving the overall quality of life in older patients with non-small cell lung cancer (NSCLC). Older patients with lung cancer undergoing chemotherapy are at an increased risk of adverse outcomes including treatment toxicity and functional and physical consequences. This makes it very challenging for the physicians to balance the benefits against the risk of chemotherapy in older cancer patients. A geriatric assessment may be useful in identifying risk factors for chemotherapy radiation toxicity. Communicating these geriatric assessment findings and assessment-based recommendations to a patient's treating physicians may help them make more informed decisions about treatment options for patients. Making treatment decisions using GA-based recommendations may reduce adverse events and improve outcomes in patients receiving treatment for NSCLC.

Key Dates

Start date
May 21, 2024
Status verified
Jul 2025
Primary completion
Jul 19, 2026
Completion
Jul 19, 2026

Study Design

Enrollment
180 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: Arm I (GA intervention)
    Patients complete a geriatric assessment. Patients and physicians receive the geriatric assessment summary and assessment-based recommendations, which are provided prior to beginning chemotherapy and radiation, at the midpoint of chemotherapy and radiation treatment, and at the end of treatment. Patients also undergo blood and stool sample collection during screening and on study.
  • Active Comparator: 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, per usual care. Patients also undergo blood and stool sample collection during screening and on study.

Primary Outcome Measure

Incidence of grade 3-5 non-hematologic toxicities [ Time Frame: At 6 months from treatment initiation ]

Locations (3)

FacilityCityStateZIPSite coordinators
City of Hope Medical CenterDuarteCalifornia91010
Arya Amini
626-256-4673
Arya Amini (PRINCIPAL_INVESTIGATOR)
University of RochesterRochesterNew York14642
Supriya G. Mohile
585-275-2121
Supriya G. Mohile (PRINCIPAL_INVESTIGATOR)
Ohio State University Comprehensive Cancer CenterColumbusOhio43210
Carolyn J. Presley
614-293-9869
Carolyn J. Presley (PRINCIPAL_INVESTIGATOR)

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