Telemedicine for Improvement of Care for Older Adults With Cancer in the Underserved Community, The GAIN-S Trial
NCT ID: NCT06022965
Last Updated: 2025-10-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
216 participants
INTERVENTIONAL
2023-07-24
2027-01-24
Brief Summary
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Detailed Description
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I. To implement Geriatric Assessment-driven interventions with supportive care (GAIN-S) through telemedicine to:
Ia. To improve communication between the primary care team (oncologist, nurses) and patients and caregivers in a remote community setting to increase prognostic discussions and goal concordant care; Ib. To improve cost-saving in older patients with cancer.
SECONDARY OBJECTIVES:
I. Determine whether GAIN-S implemented in a community setting will lead to a decrease in treatment toxicity.
II. To examine whether GAIN-S intervention will lead to improvement in hospitalizations, dose delays, dose reduction and discontinuation.
III. To compare patient satisfaction using the "Was It Worth It" (WIWI) between the 2 arms at the 3 and/or 6-month timepoint.
IV. To compare patient preferences at baseline, using the validated patient-defined treatment preference and goals measures between the 2 arms and longitudinal change, at 3 and/or 6-month timepoint.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I (GAIN-S): Patients complete the Cancer and Aging Research Group-Geriatric Assessment (CARG-GA) at baseline and 3 months and receive GA-based interventions using telemedicine over 6 months.
ARM II (SOC): Patients complete the CARG-GA at baseline and 3 months and receive SOC over 6 months.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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ARM I (GAIN-S)
Patients complete the CARG-GA at baseline and 3 months and receive GA-based interventions using telemedicine over 6 months.
Best Practice
Receive SOC
Comprehensive Geriatric Assessment
Complete CARG-GA
Electronic Health Record Review
Ancillary studies
Questionnaire Administration
Ancillary studies
Supportive Care
Receive GA-based interventions
Telemedicine
Receive GA-based interventions via telemedicine
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.
Best Practice
Receive SOC
Comprehensive Geriatric Assessment
Complete CARG-GA
Electronic Health Record Review
Ancillary studies
Questionnaire Administration
Ancillary studies
Interventions
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Best Practice
Receive SOC
Comprehensive Geriatric Assessment
Complete CARG-GA
Electronic Health Record Review
Ancillary studies
Questionnaire Administration
Ancillary studies
Supportive Care
Receive GA-based interventions
Telemedicine
Receive GA-based interventions via telemedicine
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
65 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
City of Hope Medical Center
OTHER
Responsible Party
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Principal Investigators
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William Dale
Role: PRINCIPAL_INVESTIGATOR
City of Hope Medical Center
Locations
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City of Hope Medical Center
Duarte, California, United States
City of Hope Antelope Valley
Lancaster, California, United States
City of Hope Upland
Upland, California, United States
Countries
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Facility Contacts
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Other Identifiers
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NCI-2023-05945
Identifier Type: REGISTRY
Identifier Source: secondary_id
22343
Identifier Type: OTHER
Identifier Source: secondary_id
22343
Identifier Type: -
Identifier Source: org_study_id
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