Ignite Creation Date:
2026-03-26 @ 3:19 PM
Ignite Modification Date:
2026-03-31 @ 5:19 AM
Study NCT ID:
NCT07485634
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2026-03-20
First Post:
2026-03-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Risk-Based Geriatric Assessment-Driven Management in Older Patients Starting Chemotherapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D000073496', 'term': 'Frailty'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'This study is open-label to participants and treating clinicians because the intervention involves geriatric assessment results and management recommendations that are reviewed and applied during routine care. Outcome assessors responsible for determining study endpoints, including chemotherapy-related toxicities, emergency department visits, hospitalizations, and early treatment termination, are blinded to treatment allocation. Outcomes are ascertained through independent review of clinical records and graded using standardized criteria without knowledge of group assignment.'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Participants are randomized in a 1:1 ratio to receive either usual care or usual care plus a risk-based geriatric assessment-driven management algorithm (GAMA) using a computer-generated block randomization scheme.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 70}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2024-01-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2026-10-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-16', 'studyFirstSubmitDate': '2026-03-16', 'studyFirstSubmitQcDate': '2026-03-16', 'lastUpdatePostDateStruct': {'date': '2026-03-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Recruitment, Randomization, and Retention Rates', 'timeFrame': 'Throughout the study period', 'description': 'Feasibility of trial conduct assessed by rates of recruitment, randomization, and retention, including the proportion of eligible participants recruited, successfully randomized, and completing follow-up assessments.'}, {'measure': 'Completeness of Data Collection', 'timeFrame': 'Baseline to 3 months after chemotherapy initiation', 'description': 'Extent of missing data for study outcome measures, assessed by the proportion of participants with complete baseline and follow-up data.'}, {'measure': 'Adherence to GA-MA Recommendations', 'timeFrame': 'From baseline assessment to 3-month follow-up.', 'description': 'Percentage of participants in the intervention group who follow the GA-MA recommendations provided to them.'}, {'measure': 'Feasibility of Geriatric Assessment Administration', 'timeFrame': 'At baseline and during intervention delivery', 'description': 'Feasibility of administering geriatric assessment assessed by the time required to complete baseline geriatric assessment, time required to explain assessment results in the intervention group, and the proportion of participants requiring research assistant assistance to complete self-report questionnaires.'}], 'primaryOutcomes': [{'measure': 'Incidence of Grade 3 or Higher Chemotherapy-Related Toxicities', 'timeFrame': 'From chemotherapy initiation to 3 months after initiation', 'description': 'Incidence of grade 3 or higher chemotherapy-related toxicities, assessed and graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.'}], 'secondaryOutcomes': [{'measure': 'Emergency Department Visits', 'timeFrame': 'From chemotherapy initiation to 3 months after initiation', 'description': 'Occurrence of emergency department visits after chemotherapy initiation, identified through review of clinical medical records.'}, {'measure': 'Unplanned Hospitalizations', 'timeFrame': 'From chemotherapy initiation to 3 months after initiation', 'description': 'Occurrence of unplanned hospitalizations after chemotherapy initiation, identified through review of clinical medical records.'}, {'measure': 'Early Termination of Chemotherapy', 'timeFrame': 'From chemotherapy initiation to 3 months after initiation', 'description': 'Early termination of chemotherapy due to treatment-related toxicities, defined as discontinuation of chemotherapy before completion of the planned treatment course.'}, {'measure': 'Change in Frailty Status', 'timeFrame': 'Baseline to 3 months after chemotherapy initiation', 'description': "Change in frailty status measured using the Clinical Frailty Scale (CFS), a clinician-rated global measure of frailty developed by Rockwood and colleagues. The CFS is a 9-point scale that summarizes an older adult's overall level of fitness and frailty based on clinical judgment, considering functional ability, comorbidities, and cognitive status. Scores range from 1 (very fit) to 9 (terminally ill), with higher scores indicating greater frailty."}, {'measure': 'Change in Performance Status (ECOG Performance Status)', 'timeFrame': 'Baseline to 3 months after chemotherapy initiation', 'description': 'Change in functional status measured using the Eastern Cooperative Oncology Group (ECOG) Performance Status scale, a clinician-rated measure ranging from 0 (fully active) to 4 (completely disabled), with lower scores indicating better functional status.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Cancer', 'Frailty', 'Geriatric assessment', 'Older adults', 'supportive care', 'performance status', 'Feasbility randomized controlled trial'], 'conditions': ['Cancer', 'Geriatric Syndrome', 'Frailty', 'Chemotherapy Toxicity']}, 'descriptionModule': {'briefSummary': 'Older patients with cancer are at increased risk of severe chemotherapy-related toxicities due to comorbidities, functional impairments, and geriatric syndromes. Comprehensive geriatric assessment (GA) can identify vulnerabilities and guide tailored management, but routine implementation is challenging due to time and resource constraints.\n\nThis pilot randomized controlled trial evaluates the feasibility and preliminary efficacy of a patient self-report, risk-based geriatric assessment-driven management algorithm (GA-MA) compared with usual care in older patients starting chemotherapy. Participants aged 65 years or older who are initiating a new chemotherapy regimen are randomized in a 1:1 ratio to receive either GA-MA plus usual care or usual care alone.\n\nThe primary outcome is the incidence of grade 3 or higher chemotherapy-related toxicities within three months of treatment initiation. Secondary outcomes include emergency department visits, unplanned hospitalizations, early chemotherapy termination, and changes in frailty and performance status. Feasibility outcomes include recruitment, retention, adherence to GA-driven recommendations, and time required to complete geriatric assessment.', 'detailedDescription': 'This is a single-center, prospective, pilot randomized controlled trial evaluating the feasibility and preliminary effectiveness of a risk-based geriatric assessment-driven management algorithm (GA-MA) in older patients with cancer starting chemotherapy.\n\nOlder adults receiving chemotherapy are at increased risk of severe treatment-related toxicities due to comorbidities, functional impairments, and geriatric syndromes that are not reliably identified by standard oncology assessments. Comprehensive geriatric assessment (GA) can identify these vulnerabilities and guide individualized supportive care, but routine implementation is challenging in busy oncology clinics.\n\nIn this study, patients aged 65 years or older who are initiating a new chemotherapy regimen are randomized in a 1:1 ratio to receive either usual care or usual care plus GA-MA. In the intervention arm, patients complete a baseline geriatric assessment using validated self-report tools. Results are reviewed by oncology nurses and treating oncologists, who may apply a predefined risk-based management algorithm developed with multidisciplinary input. GA-driven recommendations may include medication review, nutritional support, physiotherapy or occupational therapy referral, caregiver education, and guidance on chemotherapy dose adjustment for higher-risk patients. Intervention cases are also reviewed in regular multidisciplinary meetings.\n\nParticipants are followed for three months after chemotherapy initiation. Outcomes include the incidence of grade 3 or higher chemotherapy-related toxicities, emergency department visits, unplanned hospitalizations, early termination of chemotherapy, and changes in frailty and performance status. Feasibility outcomes include recruitment and retention rates, adherence to GA-MA recommendations, and time required to complete geriatric assessment. Results will inform the design of a future larger randomized trial and the feasibility of integrating GA-MA into routine oncology practice.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Aged 65-74 years with impaired G8 questionnaire score, or aged 75 years or older.\n* Diagnosis of lung cancer, colorectal cancer, breast cancer, gastric cancer, or uterine cancer with histological confirmation or radiological diagnosis.\n* Scheduled to receive a new systemic anti-cancer treatment that includes chemotherapy. Any line of cytotoxic chemotherapy is allowed, including regimens combined with targeted therapy or immunotherapy, provided the planned regimen is expected to last at least 3 months.\n* ECOG Performance Status 0-2.\n* Able to communicate in English or Chinese.\n* Able to provide valid informed consent.\n\nExclusion Criteria:\n\n* Planned treatment with radiotherapy alone.\n* Planned systemic treatment given concurrently with radiotherapy.\n* Planned treatment with hormonal therapy alone (e.g., tamoxifen, aromatase inhibitors, LHRH agonists).\n* Planned surgery within the next 3 months.\n* Life expectancy less than 3 months.\n* Dementia or otherwise mentally unfit to provide informed consent.'}, 'identificationModule': {'nctId': 'NCT07485634', 'briefTitle': 'Risk-Based Geriatric Assessment-Driven Management in Older Patients Starting Chemotherapy', 'organization': {'class': 'OTHER', 'fullName': 'The University of Hong Kong'}, 'officialTitle': 'Risk-based Geriatric Assessment Driven Management Algorithm in Older Patients With Cancer Starting Chemotherapy: a Pilot Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'UW 24-034'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Usual care', 'description': 'Participants in the usual care arm receive standard oncology care according to routine clinical practice. Treatment decisions, including chemotherapy dosing, supportive care, and referrals, are determined by the treating oncologist based on usual assessment and clinical judgment. Results of geriatric assessment and geriatric assessment-driven management recommendations are not provided to the treating team.'}, {'type': 'EXPERIMENTAL', 'label': 'GA-MA plus Usual Care', 'description': 'Participants in the intervention arm receive usual care plus a risk-based geriatric assessment-driven management algorithm (GA-MA). Participants complete a baseline geriatric assessment using validated self-report tools. Geriatric assessment results are reviewed by oncology nurses and treating oncologists, who may apply predefined GA-driven management recommendations. Intervention cases are also reviewed in regular multidisciplinary meetings, and recommendations are communicated to the treating oncologist.', 'interventionNames': ['Other: Geriatric Assessment-Driven Management Algorithm (GA-MA)']}], 'interventions': [{'name': 'Geriatric Assessment-Driven Management Algorithm (GA-MA)', 'type': 'OTHER', 'description': 'The GA-MA is a risk-based geriatric assessment-driven management approach designed to support individualized care for older patients starting chemotherapy. The intervention uses validated patient self-report geriatric assessment tools to identify vulnerabilities across multiple domains, including functional status, cognition, nutrition, comorbidity, medication use, and social support.\n\nBased on assessment results, predefined GA-driven recommendations may include medication review to reduce polypharmacy or drug-drug interactions, referral to physiotherapy or occupational therapy to support functional status, dietary counseling for nutritional impairment, caregiver education, and guidance on chemotherapy dose modification for patients at higher risk of treatment-related toxicity. Recommendations are structured to allow rapid review and integration into routine oncology care.', 'armGroupLabels': ['GA-MA plus Usual Care']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Hong Kong', 'country': 'Hong Kong', 'facility': 'Department of Clinical Oncology, School of Clinical Medicine, LKS Faculty of Medicine, the University of Hong Kong, Hong Kong SAR, Hong Kong,', 'geoPoint': {'lat': 22.27832, 'lon': 114.17469}}], 'overallOfficials': [{'name': 'Wing-Lok Wendy Chan', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The University of Hong Kong'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Individual participant data will not be shared due to institutional data governance requirements and to protect participant confidentiality.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The University of Hong Kong', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Associate Professor', 'investigatorFullName': 'Wing Lok Wendy Chan', 'investigatorAffiliation': 'The University of Hong Kong'}}}}