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

Summary

Participation Requirements

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...

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. Compare the number and type of GA-driven recommendations implemented for older patients starting a new treatment regimen for advanced cancer. TERTIARY OBJECTIVES: I. To determine whether providing oncology physicians with GA information and GA-driven recommendations can slow functional and physical decline in older patients with advanced cancer. II. To examine the association between patient-reported symptoms (as measured by Patient-Reported Outcomes [PRO]-Common Terminology Criteria for Adverse Events [CTCAE]) and geriatric domains (as measured by geriatric assessment). III. To compare PRO-CTCAE and physician-rated CTCAE in a sample of older patients receiving chemotherapy or other agents with similar prevalence of toxicity. IV. To examine the association between PRO-CTCAE and treatment decisions. V. To examine the association between PRO-CTCAE and adverse outcomes (early discontinuation of chemotherapy or other agents with similar prevalence of toxicity, hospitalizations, and mortality). 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.

Tracking Information