Geriatric Assessment Intervention for Reducing Toxicity in Older Patients With Advanced Cancer
NCT ID: NCT02054741
Last Updated: 2024-04-12
Study Results
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View full resultsBasic Information
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COMPLETED
NA
733 participants
INTERVENTIONAL
2014-07-29
2021-10-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Arm I (GA intervention)
Patients complete a geriatric assessment. Patients and physicians are provided with the geriatric assessment information and recommendations.
Comprehensive Geriatric Assessment
Complete geriatric assessment
Quality-of-Life Assessment
Ancillary studies
Survey Administration
Ancillary studies
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.
No interventions assigned to this group
Interventions
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Comprehensive Geriatric Assessment
Complete geriatric assessment
Quality-of-Life Assessment
Ancillary studies
Survey Administration
Ancillary studies
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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.
70 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
University of Chicago
OTHER
City of Hope National Medical Center
OTHER
Supriya Mohile
OTHER
Responsible Party
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Supriya Mohile
Professor
Principal Investigators
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Supriya Mohile
Role: PRINCIPAL_INVESTIGATOR
University of Rochester NCORP Research Base
Locations
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City of Hope
Duarte, California, United States
Delaware/Christiana Care NCORP
Newark, Delaware, United States
Hawaii MU-NCORP
Honolulu, Hawaii, United States
University of Chicago
Chicago, Illinois, United States
Heartland NCORP
Decatur, Illinois, United States
Kansas City NCORP
Prairie Village, Kansas, United States
Wichita NCORP
Wichita, Kansas, United States
Gulf South MU-NCORP
New Orleans, Louisiana, United States
Cancer Research Consortium of West Michigan
Grand Rapids, Michigan, United States
Metro Minnesota NCORP
Minneapolis, Minnesota, United States
Kansas City NCORP
Kansas City, Missouri, United States
Nevada NCORP
Las Vegas, Nevada, United States
North Shore LIJ Health System NCORP
Lake Success, New York, United States
University of Rochester
Rochester, New York, United States
Southeast Clinical Oncology Research Program
Winston-Salem, North Carolina, United States
Columbus NCORP
Columbus, Ohio, United States
Dayton NCORP
Dayton, Ohio, United States
Pacific Cancer Research Consortium Ncorp
Portland, Oregon, United States
Geisinger Cancer Institute NCORP
Danville, Pennsylvania, United States
NCORP of the Carolinas
Greenville, South Carolina, United States
Northwest NCORP
Tacoma, Washington, United States
Wisconsin NCORP
Marshfield, Wisconsin, United States
Aurora NCORP
Milwaukee, Wisconsin, United States
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
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.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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NCI-2013-01904
Identifier Type: REGISTRY
Identifier Source: secondary_id
URCC13059
Identifier Type: OTHER
Identifier Source: secondary_id
URCC-13059
Identifier Type: OTHER
Identifier Source: secondary_id
URCC-13059
Identifier Type: OTHER
Identifier Source: secondary_id
URCC13059
Identifier Type: -
Identifier Source: org_study_id
NCT02066168
Identifier Type: -
Identifier Source: nct_alias
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