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临床试验/NCT05407844
NCT05407844Enrolling By Invitation不适用

Community Health Worker Based Intervention to Improve Palliative Care

Wake Forest University Health Sciences5 个研究点 分布在 1 个国家目标入组 160 人开始时间: 2023年11月2日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
Enrolling By Invitation
入组人数
160
试验地点
5
主要终点
Number of participants who completed Advance Directives

研究概览

简要总结

The study aims to find out if community health worker (CHW) support will improve palliative care outcomes in African American patients with advanced cancer, by comparing the quality of life of patients who are receiving standard care to those whose standard care is supplemented with CHW support.

详细描述

This research is being done to establish the effectiveness of a Community Health Worker based palliative care intervention among African American patients with advanced solid organ malignancies and their care givers.

The investigators' long-term goal is to reduce the research-to-practice gap in utilization of evidence-based palliative care (PC) in African Americans with advanced cancer. The objectives of this study are to establish the effectiveness of a CHW-based palliative care intervention and develop generalizable knowledge on how contextual factors influence implementation.

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
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patient Inclusion Criteria:
  • Self-identified African American patients with advanced (AJCC stage III or IV) solid organ malignancy
  • >=18 years old
  • English speaking
  • Intact cognition and ability to provide informed consent

排除标准

  • Participants < 18 years of age
  • Participants who are already receiving palliative care services
  • Caregiver Inclusion Criteria:
  • Adult (>=18 years old) caregivers providing informal (unpaid) care to an eligible African American cancer patient (related or unrelated)
  • English speaking
  • Intact cognition and ability to provide informed consent
  • Caregiver Exclusion Criteria:
  • Participants < 18 years of age

研究组 & 干预措施

Standard care + DeCIDE PC intervention

Experimental

Community health worker support and standard cancer care

干预措施: Community Health Worker (CHW) based palliative care (Other)

Standard care

No Intervention

Standard cancer care

结局指标

主要结局

Number of participants who completed Advance Directives

时间窗: 6 months after enrollment

Advanced care planning

次要结局

  • Functional Assessment of Chronic Illness Therapy-Palliative Subscale (FACIT-PAL) score(6 months after enrollment)
  • Number of participants who utilize hospice care(6 months after enrollment)
  • Goals of care as assessed by Quality of communication (QOC) scale(6 months after enrollment)
  • Symptom Intensity as assessed by the Edmonton Symptom Assessment Score (ESAS)(6 months after enrollment)
  • Depression as assessed by the Center for Epidemiologic Studies Depression Scale (CES-D)(6 months after enrollment)
  • Quality of life assessed by the 5-Level EuroQol 5-Dimensional (EQ-5D-5L)(6 months after enrollment)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (5)

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