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 — OTHERReceive usual care
- Biospecimen Collection — PROCEDUREUndergo blood and stool sample collection
- Communication Intervention — OTHERReceive GA assessment summary and assessment-based recommendations
- Comprehensive Geriatric Assessment — OTHERComplete GA
- Electronic Health Record Review — OTHERAncillary studies
- Survey Administration — OTHERAncillary 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)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| City of Hope Medical Center | Duarte | California | 91010 | Arya Amini (PRINCIPAL_INVESTIGATOR) |
| University of Rochester | Rochester | New York | 14642 | Supriya G. Mohile (PRINCIPAL_INVESTIGATOR) |
| Ohio State University Comprehensive Cancer Center | Columbus | Ohio | 43210 | Carolyn J. Presley (PRINCIPAL_INVESTIGATOR) |
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