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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
733
Complete geriatric assessment
Ancillary studies
Ancillary studies
City of Hope
Duarte, California, United States
Patient Experienced Any Grade 3-5 Toxicity
Proportion of patients who experienced grade 3-5 toxicity within 3 months of initiation of new treatment regimen. Toxicity was graded according to the National Cancer Institute (NCI) CTCAE version (v)4.0.
Time frame: 3 months
Patient Survival at 6 Months
Proportion of patients who were alive at 6 months (183 days) after enrollment estimated by Kaplan-Meier method.
Time frame: 6 months
Reduced Dose Intensity
Proportion of patients with reduced dose intensity in cycle 1.
Time frame: 4-6 weeks
GA-driven Recommendations Made Among Patients With Impaired Physical Performance.
The type and frequency of GA-driven recommendations implemented for older patients with impaired physical performance and starting a new treatment regimen for advanced cancer. Physical Performance measures included: Timed Up and Go, Short Physical Performance Battery, Falls History, and OARS Physical Health.
Time frame: Baseline
GA-driven Recommendations Made Among Patients With Impaired Functional Status.
The type and frequency of GA-driven recommendations implemented for older patients with impaired functional status and starting a new treatment regimen for advanced cancer. Functional Status measures included: Activities of Daily Living and Instrumental Activities of Daily Living.
Time frame: Baseline
GA-driven Recommendations Made Among Patients With Impaired Comorbidities.
The type and frequency of GA-driven recommendations implemented for older patients with impaired comorbidities and starting a new treatment regimen for advanced cancer. Comorbidity measure included: OARS Comorbidity.
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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
...and 13 more locations
Time frame: Baseline
GA-driven Recommendations Made Among Patients With Impaired Cognition.
The type and frequency of GA-driven recommendations implemented for older patients with impaired cognition and starting a new treatment regimen for advanced cancer. Cognition measures included: Blessed Orientation Memory Concentration and Mini Cog assessments.
Time frame: Baseline
GA-driven Recommendations Made Among Patients With Impaired Nutrition.
The type and frequency of GA-driven recommendations implemented for older patients with impaired nutrition and starting a new treatment regimen for advanced cancer. Nutrition measures included: Body Mass Index, Weight Loss, and Mini Nutrition Assessment.
Time frame: Baseline
GA-driven Recommendations Made Among Patients With Impaired Social Support.
The type and frequency of GA-driven recommendations implemented for older patients with impaired social support and starting a new treatment regimen for advanced cancer. Social Support measure included: OARS Medical Social Support.
Time frame: Baseline
GA-driven Recommendations Made Among Patients With Impaired Polypharmacy.
The type and frequency of GA-driven recommendations implemented for older patients with impaired polypharmacy and starting a new treatment regimen for advanced cancer. Polypharmacy measure included: medication review.
Time frame: Baseline
GA-driven Recommendations Made Among Patients With Impaired Psychological Status.
The type and frequency of GA-driven recommendations implemented for older patients with impaired psychological status and starting a new treatment regimen for advanced cancer. Psychological measures included: Geriatric Depression Scale and Generalized Anxiety Disorder - 7 item scale.
Time frame: Baseline