Risk-based Geriatric Assessment Driven Management Algorithm in Older Patients With Cancer Starting Chemotherapy: a Pilot Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Incidence of Grade 3 or Higher Chemotherapy-Related Toxicities
研究概览
简要总结
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.
详细描述
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.
Older 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.
In 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.
Participants 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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-
- •Able to communicate in English or Chinese.
- •Able to provide valid informed consent.
排除标准
- •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.
结局指标
主要结局
Incidence of Grade 3 or Higher Chemotherapy-Related Toxicities
时间窗: From chemotherapy initiation to 3 months after initiation
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.
次要结局
- Emergency Department Visits(From chemotherapy initiation to 3 months after initiation)
- Unplanned Hospitalizations(From chemotherapy initiation to 3 months after initiation)
- Early Termination of Chemotherapy(From chemotherapy initiation to 3 months after initiation)
- Change in Frailty Status(Baseline to 3 months after chemotherapy initiation)
- Change in Performance Status (ECOG Performance Status)(Baseline to 3 months after chemotherapy initiation)
研究者
Wing Lok Wendy Chan
Clinical Associate Professor
The University of Hong Kong