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.
Conditions: Cancer, Geriatric Syndrome, Frailty, Chemotherapy Toxicity
Eligibility Criteria
Inclusion Criteria
- Aged 65-74 years with impaired G8 questionnaire score, or aged 75 years or older.
- Diagnosis of lung cancer, colorectal cancer, breast cancer, gastric cancer, or uterine cancer with histological confirmation or radiological diagnosis.
- 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.
- ECOG Performance Status 0-2.
- Able to communicate in English or Chinese.
- Able to provide valid informed consent.
Exclusion Criteria
- Planned treatment with radiotherapy alone.
- Planned systemic treatment given concurrently with radiotherapy.
- Planned treatment with hormonal therapy alone (e.g., tamoxifen, aromatase inhibitors, LHRH agonists).
- Planned surgery within the next 3 months.
- Life expectancy less than 3 months.
- Dementia or otherwise mentally unfit to provide informed consent.
Eligibility criteria are kept as the original English records from ClinicalTrials.gov; actual eligibility is determined by the research team's formal assessment and the informed consent form. Source: ClinicalTrials.gov, updated automatically every two weeks. Last synced: 2026年10月8日.