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

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Другое Best Practice
  Receive SOC
• Другое Comprehensive Geriatric Assessment
  Complete CARG-GA
• Другое Electronic Health Record Review
  Ancillary studies
• Другое Questionnaire Administration
  Ancillary studies
• Другое Supportive Care
  Receive GA-based interventions
• Другое Telemedicine
  Receive GA-based interventions via telemedicine

Первичные конечные точки

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

Вторичные конечные точки (5)

• Decrease in treatment toxicity [Срок оценки: At 3 months after randomization]
• Proportion of patients with dose modifications [Срок оценки: Up to 6 months]
• Patient satisfaction using the "Was It Worth It" (WIWI) [Срок оценки: At 3 and/or 6-months after treatment initiation]
• Patient preferences and goals [Срок оценки: At baseline, 3 and/or 6 months after treatment initiation]
• Association of Community Cancer Centers (ACCC) Geriatric Oncology Gap Assessment Tool [Срок оценки: Baseline and at the end of study (36 months)]

Критерии участия

Критерии включения

• 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).

Критерии исключения

• 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).

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Поддерживающая терапия

Центры проведения

США · 3 центра

• City of Hope Medical Center — Duarte
• City of Hope Antelope Valley — Lancaster
• City of Hope Upland — Upland

Идентификаторы

NCT: NCT06022965 · 22343 · NCI-2023-05945 · 22343 · P30CA033572

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗