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

Geriatric Assessment (GA)-Driven Interventions With Supportive Care (The GAIN-S Trial): Telemedicine to Increase Goal Concordant Care for Older Adults With Cancer in the Community

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.

Study Overview

• Status: Recruiting
• Conditions: Malignant Solid Neoplasm; Hematopoietic and Lymphoid System Neoplasm
• Intervention / Treatment: Other: Questionnaire Administration; Other: Best Practice; Other: Electronic Health Record Review; Other: Comprehensive Geriatric Assessment; Other: Supportive Care; Other: Telemedicine

Detailed Description

PRIMARY OBJECTIVES:

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.

• Study Type: Interventional
• Enrollment (Estimated): 216
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Duarte, California, United States, 91010
      • Recruiting
      • City of Hope Medical Center
      • Contact: William Dale; Phone Number: 626-256-4673; Email: wdale@coh.org
      • Principal Investigator: William Dale
    • Lancaster, California, United States, 93534
      • Recruiting
      • City of Hope Antelope Valley
      • Contact: William Dale; Phone Number: 626-256-4673; Email: wdale@coh.org
      • Principal Investigator: William Dale
    • Upland, California, United States, 91786
      • Recruiting
      • City of Hope Upland
      • Contact: William Dale; Phone Number: 626-256-4673; Email: wdale@coh.org
      • Principal Investigator: William Dale

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Other: Questionnaire Administration; Ancillary studies; Other: Best Practice; Receive SOC; Other Names: standard of care; standard therapy; Other: Electronic Health Record Review; Ancillary studies; Other: Comprehensive Geriatric Assessment; Complete CARG-GA; Other: Supportive Care; Receive GA-based interventions; Other Names: Supportive Therapy; Symptom Management; Therapy, Supportive; Other: Telemedicine; Receive GA-based interventions via telemedicine; Other Names: Telehealth
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.	Other: Questionnaire Administration; Ancillary studies; Other: Best Practice; Receive SOC; Other Names: standard of care; standard therapy; Other: Electronic Health Record Review; Ancillary studies; Other: Comprehensive Geriatric Assessment; Complete CARG-GA

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Decrease in treatment toxicity	Will be described using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 and will examine toxicities by grade and type. Chi-square test will be used to compare proportion of patients with grade 3-5 toxicity, dose modifications including dose change, dose delay, discontinuation as well as hospitalization, consider treatment worthwhile between two arms.	At 3 months after randomization
Patient satisfaction using the "Was It Worth It" (WIWI)	Patient satisfaction assessed as whether patients found treatment worthwhile using the "Was it Worth it" (WIWI) questionnaire. T-test will be used to compare satisfaction rating between the two arms. Chi-square test will be used to compare proportion of patients consider treatment worthwhile between the two groups.	At 3 and/or 6-months after treatment initiation
Patient preferences and goals	Patient-Defined Treatment Preferences and Goals will be measured utilizing the Health Outcomes Questionnaire, Now vs Later Tool and Attitude Scale. Will use the validated patient-defined treatment preference and goals measures between the 2 arms and longitudinal change. Descriptive statistics and plots will be used to describe and compare of longitudinal changes in patient preferences and goals will be plotted.	At baseline, 3 and/or 6 months after treatment initiation
Association of Community Cancer Centers (ACCC) Geriatric Oncology Gap Assessment Tool	The tool's name is: Association of Community Cancer Centers: Geriatric Oncology Gap Assessment Tool Scoring for the tool is based on a 1-4 scale with Level 4 representing the optimal practice. Prior to study initiation, each site will be quantitatively evaluated utilizing the evidence-based ACCC Geriatric Oncology Gap Assessment tool; each site would be reassessed at the end of the study. This tool will provide an evidence-based assessment to evaluate the current geriatric oncology efforts at each site and guide future steps for improvement to these services.	Baseline and at the end of study (36 months)
Proportion of patients with dose modifications	Defined as delays and dose change experienced by patients for each cohort at each cycle. The reason for dose modifications will be noted and attributed as possibly, probably, or definitely related to treatment. Chi-square test will be used to compare proportion of patients with grade 3-5 toxicity, dose modifications including dose change, dose delay, discontinuation as well as hospitalization, consider treatment worthwhile between two arms.	Up to 6 months

Collaborators and Investigators

• Sponsor: City of Hope Medical Center
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: William Dale, City of Hope Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): July 24, 2023
• Primary Completion (Estimated): January 24, 2027
• Study Completion (Estimated): January 24, 2027

Study Registration Dates

• First Submitted: August 21, 2023
• First Submitted That Met QC Criteria: August 28, 2023
• First Posted (Actual): September 5, 2023

Study Record Updates

• Last Update Posted (Estimated): October 6, 2025
• Last Update Submitted That Met QC Criteria: October 2, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Health Services Administration; Delivery of Health Care; Health Care Quality, Access, and Evaluation; Investigative Techniques; Epidemiologic Methods; Therapeutics; Data Collection; Health Care Evaluation Mechanisms; Quality of Health Care; Public Health; Environment and Public Health; Quality Indicators, Health Care; Patient Care; Health Services; Health Care Facilities Workforce and Services; Population Characteristics; Health Status; Demography; Epidemiologic Measurements; Guidelines as Topic; Quality Assurance, Health Care; Patient Care Management; Standard of Care; Palliative Care; Practice Guidelines as Topic; Telemedicine; Geriatric Assessment
• Other Study ID Numbers: 22343 (Other Identifier: City of Hope Comprehensive Cancer Center); P30CA033572 (U.S. NIH Grant/Contract); NCI-2023-05945 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No