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 — OTHER
    Receive SOC
  • Comprehensive Geriatric Assessment — OTHER
    Complete CARG-GA
  • Electronic Health Record Review — OTHER
    Ancillary studies
  • Questionnaire Administration — OTHER
    Ancillary studies
  • Supportive Care — OTHER
    Receive GA-based interventions
  • Telemedicine — OTHER
    Receive 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)

FacilityCityStateZIPSite coordinators
City of Hope Medical CenterDuarteCalifornia91010
William Dale
626-256-4673
William Dale (PRINCIPAL_INVESTIGATOR)
City of Hope Antelope ValleyLancasterCalifornia93534
William Dale
626-256-4673
William Dale (PRINCIPAL_INVESTIGATOR)
City of Hope UplandUplandCalifornia91786
William Dale
626-256-4673
William Dale (PRINCIPAL_INVESTIGATOR)

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