Clinical trial · Interventional
Risk-Based Geriatric Assessment-Driven Management in Older Patients Starting Chemotherapy
Risk-based Geriatric Assessment Driven Management Algorithm in Older Patients With Cancer Starting Chemotherapy: a Pilot Randomized Controlled Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
| Chemotherapy Toxicity | — | UNRESOLVED | — |
| Frailty | — | UNRESOLVED | — |
| Geriatric Syndrome | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Geriatric Assessment-Driven Management Algorithm (GA-MA) | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- 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)
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 65 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available