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

NCT02054741 | Completed Results DMC

• 6 other identifiers: URCC13059NCI-2013-01904URCC-13059UG1CA189961U10CA037420R01CA177592
• Study Type: interventional
• Target: 733
• Locations: 1 country
• Sites: 23

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.

Conditions

Adult Solid Neoplasm; Toxicity; Lymphoma

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (10)

• Patient Survival at 6 Months

  6 months

• Reduced Dose Intensity

  4-6 weeks

• GA-driven Recommendations Made Among Patients With Impaired Physical Performance.

  Baseline

• GA-driven Recommendations Made Among Patients With Impaired Functional Status.

  Baseline

• GA-driven Recommendations Made Among Patients With Impaired Comorbidities.

  Baseline

Study Arms (2)

Arm I (GA intervention)

EXPERIMENTAL

Patients complete a geriatric assessment. Patients and physicians are provided with the geriatric assessment information and recommendations.

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

Arm II (usual care)

NO INTERVENTION

Patients complete a geriatric assessment, but information other than clinically significant cognitive impairment and depression is not provided to the oncology teams.

Interventions

Comprehensive Geriatric Assessment OTHER

Complete geriatric assessment

Also known as: geriatric assessment

Arm I (GA intervention)

Quality-of-Life Assessment OTHER

Ancillary studies

Also known as: Quality of Life Assessment

Arm I (GA intervention)

Survey Administration OTHER

Ancillary studies

Arm I (GA intervention)

Eligibility Criteria

• Age: 70 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• Supriya Mohile: lead
• National Cancer Institute (NCI): collaborator
• University of Chicago: collaborator
• City of Hope National Medical Center: collaborator

Study Sites (23)

City of Hope

Duarte, California, 91010, United States

Location

Delaware/Christiana Care NCORP

Newark, Delaware, 19713, United States

Location

Hawaii MU-NCORP

Honolulu, Hawaii, 96813, United States

Location

University of Chicago

Chicago, Illinois, 60637, United States

Location

Heartland NCORP

Decatur, Illinois, 62526, United States

Location

Kansas City NCORP

Prairie Village, Kansas, 66208, United States

Location

Wichita NCORP

Wichita, Kansas, 67214, United States

Location

Gulf South MU-NCORP

New Orleans, Louisiana, 70112, United States

Location

Cancer Research Consortium of West Michigan

Grand Rapids, Michigan, 49503, United States

Location

Metro Minnesota NCORP

Minneapolis, Minnesota, 55426, United States

Location

Kansas City NCORP

Kansas City, Missouri, 64131, United States

Location

Nevada NCORP

Las Vegas, Nevada, 89106, United States

Location

North Shore LIJ Health System NCORP

Lake Success, New York, 11042, United States

Location

University of Rochester

Rochester, New York, 14642, United States

Location

Southeast Clinical Oncology Research Program

Winston-Salem, North Carolina, 27104, United States

Location

Columbus NCORP

Columbus, Ohio, 43215, United States

Location

Dayton NCORP

Dayton, Ohio, 45420, United States

Location

Pacific Cancer Research Consortium Ncorp

Portland, Oregon, 97213, United States

Location

Geisinger Cancer Institute NCORP

Danville, Pennsylvania, 17822, United States

Location

NCORP of the Carolinas

Greenville, South Carolina, 29615, United States

Location

Northwest NCORP

Tacoma, Washington, 98405-0986, United States

Location

Wisconsin NCORP

Marshfield, Wisconsin, 54449, United States

Location

Aurora NCORP

Milwaukee, Wisconsin, 53226, United States

Location

Related Publications (11)

• Flannery MA, Zhang Z, Culakova E, Loh KP, Canin B, Tylock RG, Stauffer FA, Mohamed M, Sun H, Mohile S. Decision regret in older adults with advanced cancer receiving systemic therapy: Associations with patient-reported and clinician-rated tolerability metrics. Cancer. 2025 Oct 15;131 Suppl 2(Suppl 2):e70023. doi: 10.1002/cncr.70023.

  PMID: 41123568 DERIVED

• Mohamed MR, Juba K, Awad H, Flannery M, Culakova E, Wells M, Cacciatore J, Jensen-Battaglia M, Mohile S, Ramsdale E. Effect of polypharmacy and potentially inappropriate medications on physical functional decline among older adults with advanced cancer receiving systemic treatment. Support Care Cancer. 2024 Sep 19;32(10):674. doi: 10.1007/s00520-024-08877-6.

  PMID: 39294452 DERIVED

• Lund JL, Cacciatore J, Tylock R, Su IH, Sharma S, Hinton SP, Smith S, Nowels MA, Chen X, Duberstein PR, Hanson LC, Mohile SG. Development and Evaluation of a Multisource Approach to Extend Mortality Follow-Up for Older Adults With Advanced Cancer Enrolled in Randomized Trials. JCO Clin Cancer Inform. 2024 Apr;8:e2300183. doi: 10.1200/CCI.23.00183.

  PMID: 38564692 DERIVED

• Ramsdale E, Kunduru M, Smith L, Culakova E, Shen J, Meng S, Zand M, Anand A. Supervised learning applied to classifying fallers versus non-fallers among older adults with cancer. J Geriatr Oncol. 2023 May;14(4):101498. doi: 10.1016/j.jgo.2023.101498. Epub 2023 Apr 19.

  PMID: 37084629 DERIVED

• Xu H, Mohamed M, Flannery M, Peppone L, Ramsdale E, Loh KP, Wells M, Jamieson L, Vogel VG, Hall BA, Mustian K, Mohile S, Culakova E. An Unsupervised Machine Learning Approach to Evaluating the Association of Symptom Clusters With Adverse Outcomes Among Older Adults With Advanced Cancer: A Secondary Analysis of a Randomized Clinical Trial. JAMA Netw Open. 2023 Mar 1;6(3):e234198. doi: 10.1001/jamanetworkopen.2023.4198.

  PMID: 36947036 DERIVED

• Mohamed MR, Loh KP, Mohile SG, Sohn M, Webb T, Wells M, Yilmaz S, Tylock R, Culakova E, Magnuson A, Sun CL, Bearden J, Hopkins JO, Faller BA, Klepin HD. External Validation of Risk Factors for Unplanned Hospitalization in Older Adults With Advanced Cancer Receiving Chemotherapy. J Natl Compr Canc Netw. 2023 Mar;21(3):273-280.e3. doi: 10.6004/jnccn.2022.7094.

  PMID: 36898361 DERIVED

• Mohamed MR, Mohile SG, Juba KM, Awad H, Wells M, Loh KP, Flannery M, Culakova E, Tylock RG, Ramsdale EE. Association of polypharmacy and potential drug-drug interactions with adverse treatment outcomes in older adults with advanced cancer. Cancer. 2023 Apr 1;129(7):1096-1104. doi: 10.1002/cncr.34642. Epub 2023 Jan 24.

  PMID: 36692475 DERIVED

• 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.

  PMID: 36356279 DERIVED

• 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.

  PMID: 35433441 DERIVED

• 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.

  PMID: 34741815 DERIVED

• 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.

  PMID: 34272204 DERIVED

MeSH Terms

Conditions

Lymphoma

Interventions

Geriatric Assessment

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Status; Demography; Population Characteristics; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Epidemiologic Measurements; Public Health; Environment and Public Health

Results Point of Contact

• Title: Dr. Supriya Mohile, Professor of Medicine
• Organization: University of Rochester, Medical Center

URCC_GAP70@urmc.rochester.edu

585-275-0394

Study Officials

• Supriya Mohile

  University of Rochester NCORP Research Base

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 31, 2014
• First Posted: February 4, 2014
• Study Start: July 29, 2014
• Primary Completion: October 31, 2021
• Study Completion: October 31, 2021
• Last Updated: April 12, 2024
• Results First Posted: June 9, 2023

Record last verified: 2024-04

Locations

US (23)