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

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.

Study Overview

• Status: Completed
• Conditions: Lymphoma; Toxicity; Adult Solid Neoplasm
• Intervention / Treatment: Other: Quality-of-Life Assessment; Other: Survey Administration; Other: Comprehensive Geriatric Assessment

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.

• Study Type: Interventional
• Enrollment (Actual): 733
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Duarte, California, United States, 91010
      • City of Hope
  • Delaware
    • Newark, Delaware, United States, 19713
      • Delaware/Christiana Care NCORP
  • Hawaii
    • Honolulu, Hawaii, United States, 96813
      • Hawaii MU-NCORP
  • Illinois
    • Chicago, Illinois, United States, 60637
      • University of Chicago
    • Decatur, Illinois, United States, 62526
      • Heartland NCORP
  • Kansas
    • Prairie Village, Kansas, United States, 66208
      • Kansas City NCORP
    • Wichita, Kansas, United States, 67214
      • Wichita NCORP
  • Louisiana
    • New Orleans, Louisiana, United States, 70112
      • Gulf South MU-NCORP
  • Michigan
    • Grand Rapids, Michigan, United States, 49503
      • Cancer Research Consortium of West Michigan
  • Minnesota
    • Minneapolis, Minnesota, United States, 55426
      • Metro Minnesota NCORP
  • Missouri
    • Kansas City, Missouri, United States, 64131
      • Kansas City NCORP
  • Nevada
    • Las Vegas, Nevada, United States, 89106
      • Nevada NCORP
  • New York
    • Lake Success, New York, United States, 11042
      • North Shore LIJ Health System NCORP
    • Rochester, New York, United States, 14642
      • University of Rochester
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27104
      • Southeast Clinical Oncology Research Program
  • Ohio
    • Columbus, Ohio, United States, 43215
      • Columbus NCORP
    • Dayton, Ohio, United States, 45420
      • Dayton NCORP
  • Oregon
    • Portland, Oregon, United States, 97213
      • Pacific Cancer Research Consortium NCORP
  • Pennsylvania
    • Danville, Pennsylvania, United States, 17822
      • Geisinger Cancer Institute NCORP
  • South Carolina
    • Greenville, South Carolina, United States, 29615
      • NCORP of the Carolinas
  • Washington
    • Tacoma, Washington, United States, 98405-0986
      • Northwest NCORP
  • Wisconsin
    • Marshfield, Wisconsin, United States, 54449
      • Wisconsin NCORP
    • Milwaukee, Wisconsin, United States, 53226
      • Aurora NCORP

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 70 years and older (Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm I (GA intervention); Patients complete a geriatric assessment. Patients and physicians are provided with the geriatric assessment information and recommendations.	Other: Quality-of-Life Assessment; Ancillary studies; Other Names: Quality of Life Assessment; Other: Survey Administration; Ancillary studies; Other: Comprehensive Geriatric Assessment; Complete geriatric assessment; Other Names: geriatric assessment
No Intervention: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Reduced Dose Intensity	Proportion of patients with reduced dose intensity in cycle 1.	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.	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.	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.	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.	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.	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.	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.	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.	Baseline

Collaborators and Investigators

• Sponsor: Supriya Mohile
• Collaborators: National Cancer Institute (NCI); University of Chicago; City of Hope National Medical Center
• Investigators: Principal Investigator: Supriya Mohile, University of Rochester NCORP Research Base

Publications and helpful links

General Publications

• Culakova E, Mohile SG, Peppone L, Ramsdale E, Mohamed M, Xu H, Wells M, Tylock R, Java J, Loh KP, Magnuson A, Jamieson L, Vogel V, Duberstein PR, Chapman BP, Dale W, Flannery MA. Effects of a Geriatric Assessment Intervention on Patient-Reported Symptomatic Toxicity in Older Adults With Advanced Cancer. J Clin Oncol. 2023 Feb 1;41(4):835-846. doi: 10.1200/JCO.22.00738. Epub 2022 Nov 10.
• Presley CJ, Mohamed MR, Culakova E, Flannery M, Vibhakar PH, Hoyd R, Amini A, VanderWalde N, Wong ML, Tsubata Y, Spakowicz DJ, Mohile SG. A Geriatric Assessment Intervention to Reduce Treatment Toxicity Among Older Adults With Advanced Lung Cancer: A Subgroup Analysis From a Cluster Randomized Controlled Trial. Front Oncol. 2022 Mar 31;12:835582. doi: 10.3389/fonc.2022.835582. eCollection 2022.
• Mohile SG, Mohamed MR, Xu H, Culakova E, Loh KP, Magnuson A, Flannery MA, Obrecht S, Gilmore N, Ramsdale E, Dunne RF, Wildes T, Plumb S, Patil A, Wells M, Lowenstein L, Janelsins M, Mustian K, Hopkins JO, Berenberg J, Anthony N, Dale W. Evaluation of geriatric assessment and management on the toxic effects of cancer treatment (GAP70+): a cluster-randomised study. Lancet. 2021 Nov 20;398(10314):1894-1904. doi: 10.1016/S0140-6736(21)01789-X. Epub 2021 Nov 3.
• Mohamed MR, Kyi K, Mohile SG, Xu H, Culakova E, Loh KP, Flannery M, Obrecht S, Ramsdale E, Patil A, Dunne RF, DiGiovanni G, Hezel A, Burnette B, Desai N, Giguere J, Magnuson A. Prevalence of and factors associated with treatment modification at first cycle in older adults with advanced cancer receiving palliative treatment. J Geriatr Oncol. 2021 Nov;12(8):1208-1213. doi: 10.1016/j.jgo.2021.06.007. Epub 2021 Jul 14.

Study record dates

Study Major Dates

• Study Start (Actual): July 29, 2014
• Primary Completion (Actual): October 31, 2021
• Study Completion (Actual): October 31, 2021

Study Registration Dates

• First Submitted: January 31, 2014
• First Submitted That Met QC Criteria: January 31, 2014
• First Posted (Estimated): February 4, 2014

Study Record Updates

• Last Update Posted (Actual): April 12, 2024
• Last Update Submitted That Met QC Criteria: April 10, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: URCC13059 (Other Identifier: University of Rochester); UG1CA189961 (U.S. NIH Grant/Contract); U10CA037420 (U.S. NIH Grant/Contract); NCI-2013-01904 (Registry Identifier: CTRP (Clinical Trial Reporting Program)); URCC-13059 (Other Identifier: CTEP); R01CA177592 (U.S. NIH Grant/Contract)