Geriatric Assessment in Predicting Chemotherapy Toxicity and Vulnerabilities in Older Patients With Cancer

April 16, 2026 updated by: City of Hope Medical Center

Advancing Screening and Treatment for Older Patients With Cancer

This randomized clinical trial studies a geriatric assessment intervention in predicting chemotherapy toxicity and vulnerabilities (or weakness) in older patients with cancer. Assessing patients' functional status, comorbidities, psychological state, social support, nutritional status, and cognitive function before treatment may help identify vulnerabilities, improve care, and decrease chemotherapy side effects in older patients with cancer.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

PRIMARY OBJECTIVES:

I. To identify areas of vulnerability in older adults with cancer through the use of a geriatric assessment, and to identify the potential referrals to an interdisciplinary team based on geriatric assessment results.

II. To determine whether the geriatric assessment driven interventions will lead to decrease in grade 3-5 toxicity.

SECONDARY OBJECTIVES:

I. To determine whether the geriatric assessment driven interventions will lead to improvement in the following outcomes: unplanned hospitalization, average length of stay (ALOS), emergency visits, unplanned readmission rates, and advance directive completion.

II. To determine whether there is significantly better quality of life (QOL) and function in the geriatric assessment intervention group compared to the standard of care group from start of treatment to the follow-up timepoint.

III. To determine the feasibility of delivering geriatric assessment driven interventions in a community setting using telemedicine.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I: Patients follow an intervention plan created by the nurse practitioner (NP) using the results of the geriatric assessment. The NP discusses the results of the assessment and treatment recommendations with the patient. They also share the treatment plan, proposed referrals, and specific vulnerabilities with the primary care physician and community oncologist. Some patients complete the intervention plan via Telehealth, which uses telecommunication technology to provide health services over a distance.

ARM II: Patients follow a standard of care treatment plan at the discretion of the primary oncologist. Beginning 6 months from the start of chemotherapy, patients undergo the geriatric assessment as in Arm I. Some patients complete the standard of care treatment plan via Telehealth.

Study Type

Interventional

Enrollment (Estimated)

600

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Duarte, California, United States, 91010
        • City of Hope Medical Center
      • Lancaster, California, United States, 93534
        • City of Hope Antelope Valley
      • Rancho Cucamonga, California, United States, 91730
        • City of Hope Rancho Cucamonga
      • South Pasadena, California, United States, 91030
        • City of Hope South Pasadena
      • West Covina, California, United States, 91790
        • City of Hope West Covina

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Diagnosis of a solid tumor malignancy (any stage)
  • Scheduled to start a new chemotherapy regimen (any line, combination cytotoxic chemotherapy with targeted agents are allowed)
  • English, Spanish, and/or Chinese speaking
  • Able to provide written informed consent

Exclusion Criteria:

  • Not fluent in English, Spanish and/or Chinese (because not all questionnaires have been validated in other languages)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm I (geriatric assessment-driven treatment)
Patients follow an intervention plan created by the NP using the results of the geriatric assessment. The NP discusses the results of the assessment and treatment recommendations with the patient. They also share the treatment plan, proposed referrals, and specific vulnerabilities with the primary care physician and community oncologist. Some patients complete the intervention plan via Telehealth, which uses telecommunication technology to provide health services over a distance.
Other: Quality-of-Life Assessment
Ancillary studies
Other Names:
  • Quality of Life Assessment
Other: Questionnaire Administration
Ancillary studies
Other: Survey Administration
Ancillary studies
Other: Comprehensive Geriatric Assessment
Follow geriatric assessment-driven treatment plan
Active Comparator: Arm II (standard of care)
Patients follow a standard of care treatment plan at the discretion of the primary oncologist. Beginning 6 months from the start of chemotherapy, patients undergo the geriatric assessment as in Arm I. Some patients complete the standard of care treatment plan via Telehealth.
Other: Quality-of-Life Assessment
Ancillary studies
Other Names:
  • Quality of Life Assessment
Other: Questionnaire Administration
Ancillary studies
Other: Survey Administration
Ancillary studies

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of grade 3-5 toxicity during chemotherapy
Time Frame: Up to 6 months
Compared pre versus (vs) post-chemotherapy. Tested using general linear models with an alpha of 0.05.
Up to 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of hospitalizations during chemotherapy
Time Frame: Up to 6 months
Compared pre vs post-chemotherapy. General linear models will be considered for testing, but no alpha adjustments will be applied for multiple comparisons.
Up to 6 months
Change in functional status as measured by the Older American Resources and Services Instrumental Activities of Daily Living
Time Frame: Baseline to up to 6 months
Compared pre vs post-chemotherapy. Explored using multivariate analyses. Results will be stratified by covariates such as patient age, poly- versus mono-chemotherapy, dose reduced or full dose therapy upfront, adjuvant versus metastatic disease, and number of prior chemotherapy regimens.
Baseline to up to 6 months
Change in quality of life as measured by Functional Assessment of Cancer Therapy - General
Time Frame: Baseline to up to 6 months
Compared pre vs post-chemotherapy. Explored using multivariate analyses. Results will be stratified by covariates such as patient age, poly- versus mono-chemotherapy, dose reduced or full dose therapy upfront, adjuvant versus metastatic disease, and number of prior chemotherapy regimens.
Baseline to up to 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

City of Hope Medical Center

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Daneng Li, City of Hope Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 4, 2015

Primary Completion (Estimated)

February 2, 2027

Study Completion (Estimated)

February 2, 2027

Study Registration Dates

First Submitted

July 28, 2015

First Submitted That Met QC Criteria

August 4, 2015

First Posted (Estimated)

August 6, 2015

Study Record Updates

Last Update Posted (Actual)

April 20, 2026

Last Update Submitted That Met QC Criteria

April 16, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 15161 (Other Identifier: City of Hope Medical Center)
  • NCI-2015-01202 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Solid Neoplasm

Clinical Trials on Quality-of-Life Assessment

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Liberia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe