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

NCT07485634 | Active Not Recruiting

• 1 other identifier: UW 24-034
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cancer; Frailty; Chemotherapy Toxicity; Geriatric Syndrome

Keywords

Cancer; Frailty; Geriatric assessment; Older adults; supportive care; performance status; Feasbility randomized controlled trial

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• 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

Other Outcomes (4)

• Recruitment, Randomization, and Retention Rates

  Throughout the study period

• Completeness of Data Collection

  Baseline to 3 months after chemotherapy initiation

• Adherence to GA-MA Recommendations

  From baseline assessment to 3-month follow-up.

Study Arms (2)

Usual care

NO INTERVENTION

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.

GA-MA plus Usual Care

EXPERIMENTAL

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)

Interventions

Geriatric Assessment-Driven Management Algorithm (GA-MA) OTHER

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.

GA-MA plus Usual Care

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The University of Hong Kong: lead

Study Sites (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

Location

MeSH Terms

Conditions

Neoplasms; Frailty

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Wing-Lok Wendy Chan

  The University of Hong Kong

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Associate Professor

Model Details: Participants are randomized in a 1:1 ratio to receive either usual care or usual care plus a risk-based geriatric assessment-driven management algorithm (GAMA) using a computer-generated block randomization scheme.

Study Record Dates

• First Submitted: March 16, 2026
• First Posted: March 20, 2026
• Study Start: January 22, 2024
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): October 31, 2026
• Last Updated: March 20, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)