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ACTIVE NOT RECRUITING
NCT07485634
NA

Risk-Based Geriatric Assessment-Driven Management in Older Patients Starting Chemotherapy

Sponsor: The University of Hong Kong

View on ClinicalTrials.gov

Summary

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. This 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. The 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.

Official title: Risk-based Geriatric Assessment Driven Management Algorithm in Older Patients With Cancer Starting Chemotherapy: a Pilot Randomized Controlled Trial

Key Details

Gender

All

Age Range

65 Years - Any

Study Type

INTERVENTIONAL

Enrollment

70

Start Date

2024-01-22

Completion Date

2026-10-31

Last Updated

2026-03-20

Healthy Volunteers

No

Interventions

OTHER

Geriatric Assessment-Driven Management Algorithm (GA-MA)

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. Based 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.

Locations (1)

Department of Clinical Oncology, School of Clinical Medicine, LKS Faculty of Medicine, the University of Hong Kong, Hong Kong SAR, Hong Kong,

Hong Kong, Hong Kong