NCT02054741

Geriatric Assessment Intervention for Reducing Toxicity in Older Patients With Advanced Cancer

A Geriatric Assessment Intervention for Patients Aged 70 and Over Receiving Chemotherapy or Similar Agents for Advanced Cancer: Reducing Toxicity in Older Adults

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 733 (actual)
• Sponsor: Supriya Mohile · Academic / Other
• Sex: All
• Age: 70 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Adult Solid Neoplasm
• Toxicity
• Lymphoma

Interventions

Type	Name	Description
OTHER	Comprehensive Geriatric Assessment	Complete geriatric assessment
OTHER	Quality-of-Life Assessment	Ancillary studies
OTHER	Survey Administration	Ancillary studies

Timeline

• Start date: 2014-07-29
• Primary completion: 2021-10-31
• Completion: 2021-10-31
• First posted: 2014-02-04
• Last updated: 2024-04-12
• Results posted: 2023-06-09

Locations

23 sites across 1 country: United States