CancerNCT07485634
Risk-Based Geriatric Assessment-Driven Management in Older Patients Starting Chemotherapy
A study testing Geriatric Assessment-Driven Management Algorithm (GA-MA) in people with Cancer and Geriatric Syndrome, run by The University of Hong Kong at 1 site in Hong Kong.
Trial 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… Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Cancer, Geriatric Syndrome, Frailty
- What is being tested?
- Geriatric Assessment-Driven Management Algorithm (GA-MA)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteHong Kong
- Study dates
- 22 Jan 2024to 31 Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Hong Kong1 site
Department of Clinical Oncology, School of Clinical Medicine, LKS Faculty of Medicine, the University of Hong Kong, Hong Kong SAR, Hong Kong,
Hong Kong
About this study
Official title: 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.
Read the 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.
- Conditions
- Cancer, Geriatric Syndrome, Frailty, Chemotherapy Toxicity
- Being tested
- Geriatric Assessment-Driven Management Algorithm (GA-MA)
- Keywords
- Cancer, Frailty, Geriatric assessment, Older adults, supportive care, performance status, Feasbility randomized controlled trial
- Medical subject headings
- Neoplasms, Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Geriatric Assessment-Driven Management Algorithm (GA-MA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From chemotherapy initiation to 3 months after initiation
Secondary outcomes (5)
Emergency Department Visits
Occurrence of emergency department visits after chemotherapy initiation, identified through review of clinical medical records.
Measured: From chemotherapy initiation to 3 months after initiation
Unplanned Hospitalizations
Occurrence of unplanned hospitalizations after chemotherapy initiation, identified through review of clinical medical records.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline to 3 months after chemotherapy initiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2026
- Study start22 Jan 2024
- Primary completion30 Jun 2026 (estimated)
- Study completion31 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wing Lok Wendy Chan, The University of Hong Kong
- Investigators
- Wing-Lok Wendy Chan, Principal investigator, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07485634
- Sponsor's protocol ID
- UW 24-034
- Status last verified
- Mar 2026
- First submitted
- 16 Mar 2026
- Last updated
- 20 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared due to institutional data governance requirements and to protect participant confidentiality.
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk-based Geriatric Assessment Driven Management Algorithm in Older Patients With Cancer Starting Chemotherapy: a Pilot Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07485634
- Acronym / sponsor ID
- UW 24-034
- Conditions
- Cancer, Geriatric Syndrome, Frailty, Chemotherapy Toxicity
- Keywords
- Cancer, Frailty, Geriatric assessment, Older adults, supportive care, performance status, Feasbility randomized controlled trial
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- 22 Jan 2024 (actual)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 31 Oct 2026 (estimated)
- First posted
- 20 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| 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 | Other: Geriatric Assessment-Driven Management Algorithm (GA-MA)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. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | GA-MA plus Usual Care |
Primary outcome
Incidence of Grade 3 or Higher Chemotherapy-Related Toxicities
Time frame: 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.
5 secondary outcomes
Emergency Department Visits
Time frame: From chemotherapy initiation to 3 months after initiation
Unplanned Hospitalizations
Time frame: From chemotherapy initiation to 3 months after initiation
Early Termination of Chemotherapy
Time frame: From chemotherapy initiation to 3 months after initiation
Change in Frailty Status
Time frame: Baseline to 3 months after chemotherapy initiation
Change in Performance Status (ECOG Performance Status)
Time frame: Baseline to 3 months after chemotherapy initiation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared due to institutional data governance requirements and to protect participant confidentiality.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wing-Lok Wendy Chan principal investigator
The University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Geriatric Assessment-Driven Management Algorithm (GA-MA) in people with Cancer and Geriatric Syndrome, run by The University of Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 20 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Grade 3 or Higher Chemotherapy-Related Toxicities (time frame: From chemotherapy initiation to 3 months after initiation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2026.