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

Not Applicable

Completed

Conditions: Adult Solid Neoplasm
Toxicity
Lymphoma

Interventions: Other: Comprehensive Geriatric Assessment
Other: Quality-of-Life Assessment
Other: Survey Administration

Registration Number: NCT02054741

Lead Sponsor: Supriya Mohile

Brief 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 733

Inclusion Criteria

INCLUSION CRITERIA FOR PHYSICIANS
Oncology physicians must work at a National Cancer Institute (NCI) Community Oncology Research Program (NCORP) practice site with no plans to leave that NCORP practice site or retire at the time of enrollment into the study
INCLUSION CRITERIA FOR PATIENTS
Diagnosis of an advanced solid tumor malignancy (advanced cancer) or lymphoma; in most situations, this would be a stage IV cancer; patients with a diagnosis of stage III cancer or lymphoma are eligible if cure is not possible or anticipated; clinical staging without pathological confirmation of advanced disease is allowed
Plan to start a new cancer treatment regimen within 4 weeks from time of baseline registration; the treatment regimen is up to the discretion of the treating oncology physician; the regimen must include a chemotherapy drug or other agents that have similar prevalence of toxicity; patients who will receive monoclonal antibody therapy or other cancer therapies (e.g., tyrosine kinase inhibitors) are eligible if other agents present a prevalence of toxicity similar to chemotherapy; patients who are receiving approved cancer treatment in combination with radiation are eligible; a patient may also be enrolled on a treatment trial and participate in this study, if all other inclusion and exclusion criteria are met. *Chemotherapy is defined as cytotoxic drugs; in addition, agents (e.g., monoclonal antibodies and targeted agents) that have a prevalence of grade 3-5 toxicity in older patients similar to chemotherapy (>50%) will be allowed.
Plan to be on chemotherapy or other allowable treatment for at least 3 months (minimum 70 days) and be willing to come in for study visits
Have at least one geriatric assessment domain meet the cut-off score for impairment other than polypharmacy
Able to provide informed consent, or if the oncology physician determines the patient to not have decision-making capacity, a patient-designated health care proxy (or authorized representative per institutional policies) must sign consent by the baseline visit. If the participant is found to be impaired on the Blessed-Orientation Memory Concentration Test (BOMC) during screening; they must have a health care proxy or authorized representative to be eligible to enroll.
Participant has adequate understanding of the English language

Exclusion Criteria

EXCLUSION CRITERIA FOR PATIENTS
Have surgery planned within 3 months of consent; patients who have previously received surgery are eligible
Presence of symptomatic brain metastases at time of study consent process. Patients with a history of treated brain metastases are eligible if they are not symptomatic at the time of study enrollment.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm I (GA intervention)	Survey Administration	Patients complete a geriatric assessment. Patients and physicians are provided with the geriatric assessment information and recommendations.
Arm I (GA intervention)	Comprehensive Geriatric Assessment	Patients complete a geriatric assessment. Patients and physicians are provided with the geriatric assessment information and recommendations.
Arm I (GA intervention)	Quality-of-Life Assessment	Patients complete a geriatric assessment. Patients and physicians are provided with the geriatric assessment information and recommendations.

Primary Outcome Measures

Name	Time	Method
Patient Experienced Any Grade 3-5 Toxicity	3 months	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.

Secondary Outcome Measures

Name	Time	Method
Reduced Dose Intensity	4-6 weeks	Proportion of patients with reduced dose intensity in cycle 1.
GA-driven Recommendations Made Among Patients With Impaired Functional Status.	Baseline	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.
GA-driven Recommendations Made Among Patients With Impaired Comorbidities.	Baseline	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.
GA-driven Recommendations Made Among Patients With Impaired Psychological Status.	Baseline	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.
Patient Survival at 6 Months	6 months	Proportion of patients who were alive at 6 months (183 days) after enrollment estimated by Kaplan-Meier method.
GA-driven Recommendations Made Among Patients With Impaired Nutrition.	Baseline	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.
GA-driven Recommendations Made Among Patients With Impaired Polypharmacy.	Baseline	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.
GA-driven Recommendations Made Among Patients With Impaired Social Support.	Baseline	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.
GA-driven Recommendations Made Among Patients With Impaired Physical Performance.	Baseline	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.
GA-driven Recommendations Made Among Patients With Impaired Cognition.	Baseline	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.

Trial Locations

Locations (22): City of Hope
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Duarte, California, United States
Dayton NCORP
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Dayton, Ohio, United States
North Shore LIJ Health System NCORP
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Lake Success, New York, United States
Wichita NCORP
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Wichita, Kansas, United States
Columbus NCORP
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Columbus, Ohio, United States
NCORP of the Carolinas
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Greenville, South Carolina, United States
Delaware/Christiana Care NCORP
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Newark, Delaware, United States
Cancer Research Consortium of West Michigan
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Grand Rapids, Michigan, United States
University of Chicago
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Chicago, Illinois, United States
Heartland NCORP
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Decatur, Illinois, United States
Metro Minnesota NCORP
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Minneapolis, Minnesota, United States
Nevada NCORP
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Las Vegas, Nevada, United States
Geisinger Cancer Institute NCORP
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Danville, Pennsylvania, United States
Wisconsin NCORP
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Marshfield, Wisconsin, United States
University of Rochester
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Rochester, New York, United States
Northwest NCORP
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Tacoma, Washington, United States
Hawaii MU-NCORP
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Honolulu, Hawaii, United States
Aurora NCORP
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Milwaukee, Wisconsin, United States
Kansas City NCORP
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Kansas City, Missouri, United States
Southeast Clinical Oncology Research Program
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Winston-Salem, North Carolina, United States
Gulf South MU-NCORP
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New Orleans, Louisiana, United States
Pacific Cancer Research Consortium Ncorp
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Portland, Oregon, United States