Telemedicine for Improvement of Care for Older Adults With Cancer in the Underserved Community, The GAIN-S Trial
Part of paid clinical trials in Duarte, California.
- Sponsor
- City of Hope Medical Center
- Study ID
- NCT06022965
- Status
- Recruiting
Conditions
- Hematopoietic and Lymphoid System Neoplasm
- Malignant Solid Neoplasm
Eligibility Criteria
- Sex
- ALL
- Age
- 65 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Best Practice — OTHERReceive SOC
- Comprehensive Geriatric Assessment — OTHERComplete CARG-GA
- Electronic Health Record Review — OTHERAncillary studies
- Questionnaire Administration — OTHERAncillary studies
- Supportive Care — OTHERReceive GA-based interventions
- Telemedicine — OTHERReceive GA-based interventions via telemedicine
Study Details
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.
Key Dates
- Start date
- Jul 24, 2023
- Status verified
- Oct 2025
- Primary completion
- Jan 24, 2027
- Completion
- Jan 24, 2027
Study Design
- Enrollment
- 216 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- SUPPORTIVE_CARE
Arms
- Experimental: ARM I (GAIN-S)Patients complete the CARG-GA at baseline and 3 months and receive GA-based interventions using telemedicine over 6 months.
- Active Comparator: ARM II (SOC)Receive SOC over the first 3 months, then switch to receive GA-based interventions using telemedicine for the following 3 months. Patients complete the CARG-GA at baseline and 3 months and receive SOC over 6 months.
Primary Outcome Measure
Rate of advance directive (AD) completion [ Time Frame: At start of treatment and 3 months after treatment initiation ]
Locations (3)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| City of Hope Medical Center | Duarte | California | 91010 | William Dale (PRINCIPAL_INVESTIGATOR) |
| City of Hope Antelope Valley | Lancaster | California | 93534 | William Dale (PRINCIPAL_INVESTIGATOR) |
| City of Hope Upland | Upland | California | 91786 | William Dale (PRINCIPAL_INVESTIGATOR) |
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