Clinical trial NCT06022965: Telemedicine for Improvement of Care for Older Adults With Cancer in the Underserved Community, The GAIN-S Trial
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hematopoietic and Lymphoid System Neoplasm
Malignant Solid Neoplasm
Lead sponsor: City of Hope Medical Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2023-09-05
Enrollment: 216
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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.

Eligibility criteria: 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).

Primary outcomes:
measure: Rate of advance directive (AD) completion
timeFrame: At start of treatment and 3 months after treatment initiation
measure: Number of documented conversations.
timeFrame: At start of treatment and 3 months after treatment initiation
measure: Direct inpatient cost
timeFrame: At 3 and 6-months after treatment initiation
Secondary outcomes:
measure: Decrease in treatment toxicity
timeFrame: At 3 months after randomization
measure: Proportion of patients with dose modifications
timeFrame: Up to 6 months
measure: Patient satisfaction using the "Was It Worth It" (WIWI)
timeFrame: At 3 and/or 6-months after treatment initiation
measure: Patient preferences and goals
timeFrame: At baseline, 3 and/or 6 months after treatment initiation
measure: Association of Community Cancer Centers (ACCC) Geriatric Oncology Gap Assessment Tool
timeFrame: Baseline and at the end of study (36 months)
Other outcomes:
Locations:
city: Duarte
country: United States
facility: City of Hope Medical Center
state: California
city: Lancaster
country: United States
facility: City of Hope Antelope Valley
state: California
city: Upland
country: United States
facility: City of Hope Upland
state: California
Study officials:
affiliation: City of Hope Medical Center
name: William Dale
role: PRINCIPAL_INVESTIGATOR
References: