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临床试验/NCT06022965
NCT06022965招募中不适用

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

City of Hope Medical Center6 个研究点 分布在 1 个国家目标入组 216 人开始时间: 2023年7月24日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
216
试验地点
6
主要终点
Rate of advance directive (AD) completion

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
65 Years 至 —(Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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).

排除标准

  • 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).

结局指标

主要结局

Rate of advance directive (AD) completion

时间窗: At start of treatment and 3 months after treatment initiation

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

Number of documented conversations.

时间窗: At start of treatment and 3 months after treatment initiation

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

Direct inpatient cost

时间窗: At 3 and 6-months after treatment initiation

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.

次要结局

  • Decrease in treatment toxicity(At 3 months after randomization)
  • Proportion of patients with dose modifications(Up to 6 months)
  • Patient preferences and goals(At baseline, 3 and/or 6 months after treatment initiation)
  • Patient satisfaction using the "Was It Worth It" (WIWI)(At 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))

研究者

发起方
City of Hope Medical Center
申办方类型
Other
责任方
Sponsor

研究点 (6)

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