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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

600 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-08-04

Study Completion Date

2026-02-28

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Geriatric Assessment Intervention for Reducing Toxicity in Older Patients With Advanced Cancer

NCT02054741

Adult Solid Neoplasm Toxicity Lymphoma

COMPLETED NA

Evaluation of Geriatric Assessment and Management for Older Adults With Non-small Cell Lung Cancer Receiving Chemotherapy Radiation Therapy

NCT06139627

Lung Non-Small Cell Carcinoma Stage III Lung Cancer AJCC v8

RECRUITING NA

Assessment of Older Adults With Cancer: Feasibility of Computer Survey Methodology

NCT00977834

Assessment, Geriatric

COMPLETED

Technology to Assess Vulnerable Older Adults With Cancer and Their Caregivers

NCT02041416

Cancer Solid Tumor Hematologic Malignancy

ACTIVE_NOT_RECRUITING

Geriatric Assessment and Management for Older Adults Undergoing Chemotherapy and Radiation Therapy for Head and Neck Cancer and Their Family Caregivers

NCT07225855

Localized Head and Neck Carcinoma

NOT_YET_RECRUITING NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Solid Neoplasm

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

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