Telemedicine for Improvement of Care for Older Adults With Cancer in the Underserved Community, The GAIN-S Trial

NCT06022965 | Recruiting DMC

• 3 other identifiers: 22343NCI-2023-05945P30CA033572
• Study Type: interventional
• Target: 216
• Locations: 1 country
• Sites: 3

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

Outcome Measures

Primary Outcomes (3)

• Rate of advance directive (AD) completion

  Will be assessed using medical chart review. Chi-square test will be used to compare the proportions of AD completion between the two arms.

  At start of treatment and 3 months after treatment initiation

• Number of documented conversations.

  Will be assessed using medical chart review. T-test will be used to compare the mean number of documented conversations between the two arms.

  At start of treatment and 3 months after treatment initiation

• Direct inpatient cost

  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.

  At 3 and 6-months after treatment initiation

Secondary Outcomes (5)

• Decrease in treatment toxicity

  At 3 months after randomization

• Proportion of patients with dose modifications

  Up to 6 months

• Patient satisfaction using the "Was It Worth It" (WIWI)

  At 3 and/or 6-months after treatment initiation

• Patient preferences and goals

  At baseline, 3 and/or 6 months after treatment initiation

• Association of Community Cancer Centers (ACCC) Geriatric Oncology Gap Assessment Tool

  Baseline and at the end of study (36 months)

Study Arms (2)

ARM I (GAIN-S)

EXPERIMENTAL

Patients complete the CARG-GA at baseline and 3 months and receive GA-based interventions using telemedicine over 6 months.

Other: Best Practice; Other: Comprehensive Geriatric Assessment; Other: Electronic Health Record Review; Other: Questionnaire Administration; Other: Supportive Care; Other: Telemedicine

ARM II (SOC)

ACTIVE COMPARATOR

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.

Other: Best Practice; Other: Comprehensive Geriatric Assessment; Other: Electronic Health Record Review; Other: Questionnaire Administration

Interventions

Best Practice OTHER

Receive SOC

Also known as: standard of care, standard therapy

ARM I (GAIN-S); ARM II (SOC)

Comprehensive Geriatric Assessment OTHER

Complete CARG-GA

ARM I (GAIN-S); ARM II (SOC)

Electronic Health Record Review OTHER

Ancillary studies

ARM I (GAIN-S); ARM II (SOC)

Questionnaire Administration OTHER

Ancillary studies

ARM I (GAIN-S); ARM II (SOC)

Supportive Care OTHER

Receive GA-based interventions

Also known as: Supportive Therapy, Symptom Management, Therapy, Supportive

ARM I (GAIN-S)

Telemedicine OTHER

Receive GA-based interventions via telemedicine

Also known as: Telehealth

ARM I (GAIN-S)

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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).

Sponsors & Collaborators

• City of Hope Medical Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (3)

City of Hope Medical Center

Duarte, California, 91010, United States

RECRUITING

City of Hope Antelope Valley

Lancaster, California, 93534, United States

RECRUITING

City of Hope Upland

Upland, California, 91786, United States

RECRUITING

MeSH Terms

Interventions

Practice Guidelines as Topic; Standard of Care; Geriatric Assessment; Palliative Care; Telemedicine

Intervention Hierarchy (Ancestors)

Guidelines as Topic; Quality Assurance, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation; Quality Indicators, Health Care; Data Collection; Epidemiologic Methods; Investigative Techniques; Health Status; Demography; Population Characteristics; Health Care Evaluation Mechanisms; Epidemiologic Measurements; Public Health; Environment and Public Health; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services; Delivery of Health Care; Patient Care Management

Study Officials

• William Dale

  City of Hope Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 21, 2023
• First Posted: September 5, 2023
• Study Start: July 24, 2023
• Primary Completion (Estimated): January 24, 2027
• Study Completion (Estimated): January 24, 2027
• Last Updated: October 6, 2025

Record last verified: 2025-10

Locations

US (3)