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

• ClinicalTrials.gov Identifier: NCT02054741
• Recruitment Status: Completed
• First Posted: February 4, 2014
• Results First Posted: June 9, 2023
• Last Update Posted: April 12, 2024
• Sponsor: Supriya Mohile
• Collaborators: National Cancer Institute (NCI); University of Chicago; City of Hope National Medical Center
• Information provided by (Responsible Party): Supriya Mohile, University of Rochester NCORP Research Base

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Adult Solid Neoplasm; Toxicity; Lymphoma	Other: Comprehensive Geriatric Assessment; Other: Quality-of-Life Assessment; Other: Survey Administration	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 733 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• 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
• Actual Study Start Date: July 29, 2014
• Actual Primary Completion Date: October 31, 2021
• Actual Study Completion Date: October 31, 2021

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. Patient Experienced Any Grade 3-5 Toxicity [ Time Frame: 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 :

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

Eligibility Criteria

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

Criteria

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.

Contacts and Locations

Locations

United States, California

City of Hope

Duarte, California, United States, 91010

United States, Delaware

Delaware/Christiana Care NCORP

Newark, Delaware, United States, 19713

United States, Hawaii

Hawaii MU-NCORP

Honolulu, Hawaii, United States, 96813

United States, Illinois

University of Chicago

Chicago, Illinois, United States, 60637

Heartland NCORP

Decatur, Illinois, United States, 62526

United States, Kansas

Kansas City NCORP

Prairie Village, Kansas, United States, 66208

Wichita NCORP

Wichita, Kansas, United States, 67214

United States, Louisiana

Gulf South MU-NCORP

New Orleans, Louisiana, United States, 70112

United States, Michigan

Cancer Research Consortium of West Michigan

Grand Rapids, Michigan, United States, 49503

United States, Minnesota

Metro Minnesota NCORP

Minneapolis, Minnesota, United States, 55426

United States, Missouri

Kansas City NCORP

Kansas City, Missouri, United States, 64131

United States, Nevada

Nevada NCORP

Las Vegas, Nevada, United States, 89106

United States, New York

North Shore LIJ Health System NCORP

Lake Success, New York, United States, 11042

University of Rochester

Rochester, New York, United States, 14642

United States, North Carolina

Southeast Clinical Oncology Research Program

Winston-Salem, North Carolina, United States, 27104

United States, Ohio

Columbus NCORP

Columbus, Ohio, United States, 43215

Dayton NCORP

Dayton, Ohio, United States, 45420

United States, Oregon

Pacific Cancer Research Consortium Ncorp

Portland, Oregon, United States, 97213

United States, Pennsylvania

Geisinger Cancer Institute NCORP

Danville, Pennsylvania, United States, 17822

United States, South Carolina

NCORP of the Carolinas

Greenville, South Carolina, United States, 29615

United States, Washington

Northwest NCORP

Tacoma, Washington, United States, 98405-0986

United States, Wisconsin

Wisconsin NCORP

Marshfield, Wisconsin, United States, 54449

Aurora NCORP

Milwaukee, Wisconsin, United States, 53226

Sponsors and Collaborators

Supriya Mohile

National Cancer Institute (NCI)

University of Chicago

City of Hope National Medical Center

Investigators

• Principal Investigator: Supriya Mohile; University of Rochester NCORP Research Base

  Study Documents (Full-Text)

Documents provided by Supriya Mohile, University of Rochester NCORP Research Base:

Study Protocol and Statistical Analysis Plan  [PDF] September 26, 2016

Informed Consent Form  [PDF] May 8, 2019

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Supriya Mohile, Professor, University of Rochester NCORP Research Base
• ClinicalTrials.gov Identifier: NCT02054741
• Obsolete Identifiers: NCT02066168
• Other Study ID Numbers: URCC13059; NCI-2013-01904 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) ); URCC13059 ( Other Identifier: University of Rochester ); URCC-13059 ( Other Identifier: DCP ); URCC-13059 ( Other Identifier: CTEP ); UG1CA189961 ( U.S. NIH Grant/Contract ); U10CA037420 ( U.S. NIH Grant/Contract ); R01CA177592 ( U.S. NIH Grant/Contract )
• First Posted: February 4, 2014
• Results First Posted: June 9, 2023
• Last Update Posted: April 12, 2024
• Last Verified: April 2024