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

Lymphoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02054741
• Other study ID #: URCC13059
• Secondary ID: NCI-2013-01904UR
• Status: Completed
• Phase: N/A
• Start date: July 29, 2014
• Est. completion date: October 31, 2021

Study information

• Verified date: April 2024
• Source: University of Rochester
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Other known NCT identifiers

• NCT02066168

Recruitment information / eligibility

• Status: Completed
• Enrollment: 733
• Est. completion date: October 31, 2021
• Est. primary completion date: October 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 70 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Adult Solid Neoplasm
• Lymphoma
• Toxicity

Intervention

Other:
• Comprehensive Geriatric Assessment
Complete geriatric assessment
• Quality-of-Life Assessment
Ancillary studies
• Survey Administration
Ancillary studies

Locations

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

Sponsors (4)

Lead Sponsor	Collaborator
Supriya Mohile	City of Hope National Medical Center, National Cancer Institute (NCI), University of Chicago

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	3 months
Secondary	Patient Survival at 6 Months	Proportion of patients who were alive at 6 months (183 days) after enrollment estimated by Kaplan-Meier method.	6 months
Secondary	Reduced Dose Intensity	Proportion of patients with reduced dose intensity in cycle 1.	4-6 weeks
Secondary	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.	Baseline
Secondary	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.	Baseline
Secondary	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.	Baseline
Secondary	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.	Baseline
Secondary	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.	Baseline
Secondary	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.	Baseline
Secondary	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.	Baseline
Secondary	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.	Baseline