Ignite Creation Date:
2025-12-25 @ 2:37 AM
Ignite Modification Date:
2026-01-26 @ 1:37 PM
Study NCT ID:
NCT02517034
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-06-17
First Post:
2015-07-28
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Geriatric Assessment in Predicting Chemotherapy Toxicity and Vulnerabilities in Older Patients With Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D015577', 'term': 'Geriatric Assessment'}], 'ancestors': [{'id': 'D003625', 'term': 'Data Collection'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D006304', 'term': 'Health Status'}, {'id': 'D003710', 'term': 'Demography'}, {'id': 'D011154', 'term': 'Population Characteristics'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D015991', 'term': 'Epidemiologic Measurements'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 600}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2015-08-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2026-02-28', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-13', 'studyFirstSubmitDate': '2015-07-28', 'studyFirstSubmitQcDate': '2015-08-04', 'lastUpdatePostDateStruct': {'date': '2025-06-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-08-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-02-28', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rate of grade 3-5 toxicity during chemotherapy', 'timeFrame': 'Up to 6 months', 'description': 'Compared pre versus (vs) post-chemotherapy. Tested using general linear models with an alpha of 0.05.'}], 'secondaryOutcomes': [{'measure': 'Rate of hospitalizations during chemotherapy', 'timeFrame': 'Up to 6 months', 'description': 'Compared pre vs post-chemotherapy. General linear models will be considered for testing, but no alpha adjustments will be applied for multiple comparisons.'}, {'measure': 'Change in functional status as measured by the Older American Resources and Services Instrumental Activities of Daily Living', 'timeFrame': 'Baseline to up to 6 months', 'description': 'Compared pre vs post-chemotherapy. Explored using multivariate analyses. Results will be stratified by covariates such as patient age, poly- versus mono-chemotherapy, dose reduced or full dose therapy upfront, adjuvant versus metastatic disease, and number of prior chemotherapy regimens.'}, {'measure': 'Change in quality of life as measured by Functional Assessment of Cancer Therapy - General', 'timeFrame': 'Baseline to up to 6 months', 'description': 'Compared pre vs post-chemotherapy. Explored using multivariate analyses. Results will be stratified by covariates such as patient age, poly- versus mono-chemotherapy, dose reduced or full dose therapy upfront, adjuvant versus metastatic disease, and number of prior chemotherapy regimens.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Solid Neoplasm']}, 'referencesModule': {'references': [{'pmid': '34591080', 'type': 'DERIVED', 'citation': 'Li D, Sun CL, Kim H, Soto-Perez-de-Celis E, Chung V, Koczywas M, Fakih M, Chao J, Cabrera Chien L, Charles K, Hughes SFDS, Katheria V, Trent M, Roberts E, Jayani R, Moreno J, Kelly C, Sedrak MS, Dale W. Geriatric Assessment-Driven Intervention (GAIN) on Chemotherapy-Related Toxic Effects in Older Adults With Cancer: A Randomized Clinical Trial. JAMA Oncol. 2021 Nov 1;7(11):e214158. doi: 10.1001/jamaoncol.2021.4158. Epub 2021 Nov 18.'}]}, 'descriptionModule': {'briefSummary': "This randomized clinical trial studies a geriatric assessment intervention in predicting chemotherapy toxicity and vulnerabilities (or weakness) in older patients with cancer. Assessing patients' functional status, comorbidities, psychological state, social support, nutritional status, and cognitive function before treatment may help identify vulnerabilities, improve care, and decrease chemotherapy side effects in older patients with cancer.", 'detailedDescription': 'PRIMARY OBJECTIVES:\n\nI. To identify areas of vulnerability in older adults with cancer through the use of a geriatric assessment, and to identify the potential referrals to an interdisciplinary team based on geriatric assessment results.\n\nII. To determine whether the geriatric assessment driven interventions will lead to decrease in grade 3-5 toxicity.\n\nSECONDARY OBJECTIVES:\n\nI. To determine whether the geriatric assessment driven interventions will lead to improvement in the following outcomes: unplanned hospitalization, average length of stay (ALOS), emergency visits, unplanned readmission rates, and advance directive completion.\n\nII. To determine whether there is significantly better quality of life (QOL) and function in the geriatric assessment intervention group compared to the standard of care group from start of treatment to the follow-up timepoint.\n\nIII. To determine the feasibility of delivering geriatric assessment driven interventions in a community setting using telemedicine.\n\nOUTLINE: Patients are randomized to 1 of 2 arms.\n\nARM I: Patients follow an intervention plan created by the nurse practitioner (NP) using the results of the geriatric assessment. The NP discusses the results of the assessment and treatment recommendations with the patient. They also share the treatment plan, proposed referrals, and specific vulnerabilities with the primary care physician and community oncologist. Some patients complete the intervention plan via Telehealth, which uses telecommunication technology to provide health services over a distance.\n\nARM II: Patients follow a standard of care treatment plan at the discretion of the primary oncologist. Beginning 6 months from the start of chemotherapy, patients undergo the geriatric assessment as in Arm I. Some patients complete the standard of care treatment plan via Telehealth.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of a solid tumor malignancy (any stage)\n* Scheduled to start a new chemotherapy regimen (any line, combination cytotoxic chemotherapy with targeted agents are allowed)\n* English, Spanish, and/or Chinese speaking\n* Able to provide written informed consent\n\nExclusion Criteria:\n\n* Not fluent in English, Spanish and/or Chinese (because not all questionnaires have been validated in other languages)'}, 'identificationModule': {'nctId': 'NCT02517034', 'briefTitle': 'Geriatric Assessment in Predicting Chemotherapy Toxicity and Vulnerabilities in Older Patients With Cancer', 'organization': {'class': 'OTHER', 'fullName': 'City of Hope Medical Center'}, 'officialTitle': 'Advancing Screening and Treatment for Older Patients With Cancer', 'orgStudyIdInfo': {'id': '15161'}, 'secondaryIdInfos': [{'id': 'NCI-2015-01202', 'type': 'REGISTRY', 'domain': 'CTRP (Clinical Trial Reporting Program)'}, {'id': '15161', 'type': 'OTHER', 'domain': 'City of Hope Medical Center'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm I (geriatric assessment-driven treatment)', 'description': 'Patients follow an intervention plan created by the NP using the results of the geriatric assessment. The NP discusses the results of the assessment and treatment recommendations with the patient. They also share the treatment plan, proposed referrals, and specific vulnerabilities with the primary care physician and community oncologist. Some patients complete the intervention plan via Telehealth, which uses telecommunication technology to provide health services over a distance.', 'interventionNames': ['Other: Comprehensive Geriatric Assessment', 'Other: Quality-of-Life Assessment', 'Other: Questionnaire Administration', 'Other: Survey Administration']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Arm II (standard of care)', 'description': 'Patients follow a standard of care treatment plan at the discretion of the primary oncologist. Beginning 6 months from the start of chemotherapy, patients undergo the geriatric assessment as in Arm I. Some patients complete the standard of care treatment plan via Telehealth.', 'interventionNames': ['Other: Quality-of-Life Assessment', 'Other: Questionnaire Administration', 'Other: Survey Administration']}], 'interventions': [{'name': 'Comprehensive Geriatric Assessment', 'type': 'OTHER', 'description': 'Follow geriatric assessment-driven treatment plan', 'armGroupLabels': ['Arm I (geriatric assessment-driven treatment)']}, {'name': 'Quality-of-Life Assessment', 'type': 'OTHER', 'otherNames': ['Quality of Life Assessment'], 'description': 'Ancillary studies', 'armGroupLabels': ['Arm I (geriatric assessment-driven treatment)', 'Arm II (standard of care)']}, {'name': 'Questionnaire Administration', 'type': 'OTHER', 'description': 'Ancillary studies', 'armGroupLabels': ['Arm I (geriatric assessment-driven treatment)', 'Arm II (standard of care)']}, {'name': 'Survey Administration', 'type': 'OTHER', 'description': 'Ancillary studies', 'armGroupLabels': ['Arm I (geriatric assessment-driven treatment)', 'Arm II (standard of care)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '91010', 'city': 'Duarte', 'state': 'California', 'country': 'United States', 'facility': 'City of Hope Medical Center', 'geoPoint': {'lat': 34.13945, 'lon': -117.97729}}, {'zip': '93534', 'city': 'Lancaster', 'state': 'California', 'country': 'United States', 'facility': 'City of Hope Antelope Valley', 'geoPoint': {'lat': 34.69804, 'lon': -118.13674}}, {'zip': '91730', 'city': 'Rancho Cucamonga', 'state': 'California', 'country': 'United States', 'facility': 'City of Hope Rancho Cucamonga', 'geoPoint': {'lat': 34.1064, 'lon': -117.59311}}, {'zip': '91030', 'city': 'South Pasadena', 'state': 'California', 'country': 'United States', 'facility': 'City of Hope South Pasadena', 'geoPoint': {'lat': 34.11612, 'lon': -118.15035}}, {'zip': '91790', 'city': 'West Covina', 'state': 'California', 'country': 'United States', 'facility': 'City of Hope West Covina', 'geoPoint': {'lat': 34.06862, 'lon': -117.93895}}], 'overallOfficials': [{'name': 'Daneng Li', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'City of Hope Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'City of Hope Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}