NCT06022965 · City of Hope Medical Center
Telemedicine for Improvement of Care for Older Adults With Cancer in the Underserved Community, The GAIN-S Trial
What this study is about
This clinical trial evaluates whether geriatric assessment-driven interventions with supportive care (GAIN-S) using telemedicine can be used to identify areas of vulnerability (weakness) in older adults with cancer and guide interventions to assist the patient and the healthcare team in the underserved community.
View original scientific description
This clinical trial evaluates whether geriatric assessment-driven interventions with supportive care (GAIN-S) using telemedicine can be used to identify areas of vulnerability (weakness) in older adults with cancer and guide interventions to assist the patient and the healthcare team in the underserved community. The majority of patients diagnosed with cancer are over age 65 years, yet most cancer treatments are developed and tested in a younger population. Therefore, older patients with cancer are less likely to be offered standard treatments because of the concern regarding side effects. Geriatric assessment (GA) is a multi-dimensional health assessment tool combining patient reported and objective (unbiased) results. There is no standard tool that can identify which older adults will be more likely to have side effects from cancer treatment. Telemedicine is a way to provide healthcare services (including consultations, education, care management and treatment) in which the health care provider is at a distant site. The goal of this project is to use telemedicine to identify areas of vulnerability/weakness in older adults with cancer using a patient assessment, and to identify the potential referrals to a multi-specialty team based on patient assessment results. Information gathered from this study may help researchers learn whether GAIN-S can be performed using telemedicine and lead to improvement in care for older adults compared to standard of care (SOC) in the underserved community.
Interventions
OTHER
Best Practice
Receive SOC
OTHER
Comprehensive Geriatric Assessment
Complete CARG-GA
OTHER
Electronic Health Record Review
Ancillary studies
OTHER
Questionnaire Administration
Ancillary studies
OTHER
Supportive Care
Receive GA-based interventions
OTHER
Telemedicine
Receive GA-based interventions via telemedicine
Primary outcome measures
Rate of advance directive (AD) completion
Time frame: At start of treatment and 3 months after treatment initiation
Will be assessed using medical chart review. Chi-square test will be used to compare the proportions of AD completion between the two arms.
Number of documented conversations.
Time frame: At start of treatment and 3 months after treatment initiation
Will be assessed using medical chart review. T-test will be used to compare the mean number of documented conversations between the two arms.
Direct inpatient cost
Time frame: At 3 and 6-months after treatment initiation
Will log transformed and Z-score test will be used to compare the mean costs of the two arms. Chi-square test will be used to compare number of patients with short verse (vs.) long stay and Intensive Care Unit (ICU) admission between the two arms.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Documented informed consent of the participant.
- Patient's physician must agree for patient participation.
- Ability to read English, Spanish, or Chinese. Other languages will be acceptable with site principal investigator (PI) agreement if surveys are available, and language does not preclude completing study procedures.
- Age: \>=65 years at the time of enrollment.
- Diagnosis of stage I-IV cancer.
- Scheduled to start a new therapy (chemotherapy, immunotherapy, or targeted therapy).
Exclusion criteria
- Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility/logistics).
Where
- Duarte, California
- Lancaster, California
- Upland, California
Collaborators
National Cancer Institute (NCI)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Oct 6, 2025 · Source of record for eligibility and locations