Recruiting

Telemedicine

Sponsor:

City of Hope Medical Center

Code:

NCT06022965

Conditions

Hematopoietic and Lymphoid System Neoplasm

Malignant Solid Neoplasm

Eligibility Criteria

Sex: All

Age: 65+

Healthy Volunteers: Not accepted

Interventions

Best Practice

Comprehensive Geriatric Assessment

Electronic Health Record Review

Questionnaire Administration

Supportive Care

Study Details

Brief summary:

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.

Conditions

Hematopoietic and Lymphoid System Neoplasm

Malignant Solid Neoplasm

Study ID

NCT06022965

Start date

Jul 24, 2023

Status verified date

Oct, 2025

Completion date

Jan 24, 2027

Anticipated

Primary completion date

Jan 24, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 65+

Healthy Volunteers: Not accepted

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).

Study Design

Enrollment

216 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

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.

Interventions

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

Primary outcome measure

  • Rate of advance directive (AD) completion [ Time Frame: At start of treatment and 3 months after treatment initiation ]
  • Number of documented conversations. [ Time Frame: At start of treatment and 3 months after treatment initiation ]
  • Direct inpatient cost [ Time Frame: At 3 and 6-months after treatment initiation ]

Central Contacts and Locations

Locations

City of Hope Medical Center

Recruiting

Duarte, California, United States, 91010

Contacts

Principal Investigator:

William Dale

City of Hope Antelope Valley

Recruiting

Lancaster, California, United States, 93534

Contacts

Principal Investigator:

William Dale

City of Hope Upland

Recruiting

Upland, California, United States, 91786

Contacts

Principal Investigator:

William Dale

More Information

Sponsor

City of Hope Medical Center

Last update posted

Oct 6, 2025

Last verified

Oct, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by City of Hope Medical Center on 2025-10-06.