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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Cancer; Frailty; Geriatric Syndrome; Chemotherapy Toxicity
• Intervention / Treatment: Other: Geriatric Assessment-Driven Management Algorithm (GA-MA)

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 70
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Usual care; 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.
Experimental: GA-MA plus Usual Care; 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Grade 3 or Higher Chemotherapy-Related Toxicities	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.	From chemotherapy initiation to 3 months after initiation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Emergency Department Visits	Occurrence of emergency department visits after chemotherapy initiation, identified through review of clinical medical records.	From chemotherapy initiation to 3 months after initiation
Unplanned Hospitalizations	Occurrence of unplanned hospitalizations after chemotherapy initiation, identified through review of clinical medical records.	From chemotherapy initiation to 3 months after initiation
Early Termination of Chemotherapy	Early termination of chemotherapy due to treatment-related toxicities, defined as discontinuation of chemotherapy before completion of the planned treatment course.	From chemotherapy initiation to 3 months after initiation
Change in Frailty Status	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.	Baseline to 3 months after chemotherapy initiation
Change in Performance Status (ECOG Performance Status)	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.	Baseline to 3 months after chemotherapy initiation

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Recruitment, Randomization, and Retention Rates	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.	Throughout the study period
Completeness of Data Collection	Extent of missing data for study outcome measures, assessed by the proportion of participants with complete baseline and follow-up data.	Baseline to 3 months after chemotherapy initiation
Adherence to GA-MA Recommendations	Percentage of participants in the intervention group who follow the GA-MA recommendations provided to them.	From baseline assessment to 3-month follow-up.
Feasibility of Geriatric Assessment Administration	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.	At baseline and during intervention delivery

Collaborators and Investigators

• Sponsor: The University of Hong Kong
• Investigators: Principal Investigator: Wing-Lok Wendy Chan, The University of Hong Kong

Study record dates

Study Major Dates

• Study Start (Actual): January 22, 2024
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): October 31, 2026

Study Registration Dates

• First Submitted: March 16, 2026
• First Submitted That Met QC Criteria: March 16, 2026
• First Posted (Actual): March 20, 2026

Study Record Updates

• Last Update Posted (Actual): March 20, 2026
• Last Update Submitted That Met QC Criteria: March 16, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Cancer; Older adults; supportive care; Frailty; Geriatric assessment; performance status; Feasbility randomized controlled trial
• Additional Relevant MeSH Terms: Pathologic Processes; Pathological Conditions, Signs and Symptoms; Frailty; Neoplasms
• Other Study ID Numbers: UW 24-034

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data will not be shared due to institutional data governance requirements and to protect participant confidentiality.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No