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临床试验/NCT03712436
NCT03712436已完成不适用

A Study of Early Palliative Care in Newly Diagnosed Cancer Patients at Black Lion Hospital, Addis Ababa, Ethiopia

Yale University1 个研究点 分布在 1 个国家目标入组 98 人开始时间: 2018年6月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
98
试验地点
1
主要终点
African Palliative Care Association Palliative Outcome Scale (APCA POS) score

研究概览

简要总结

To understand the impact of initiation of palliative care in this low-resource setting, and whether palliative care is a cost-reducing intervention that will improve patient-reported outcomes and quality of life.

详细描述

The investigators overall goal is to understand the impact of initiation of early palliative care in an oncology population in a low-resource setting in order to provide guidance for future public health policies surrounding the provision of palliative care in Ethiopia. Hypothesis: The investigators hypothesize that initiation of palliative care in this low-resource setting is a cost-reducing intervention that will improve patient-reported outcomes and quality of life. Preliminary data: This research will focus on adult patients with oncologic diagnoses as preliminary research in this setting revealed that this patient population had the highest depression and anxiety scores, the lowest palliative outcome scores, and reported the highest costs of medical care.

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
Double (Participant, Care Provider)

盲法说明

blinded

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

  • Patients with any newly diagnosed cancer who are ambulatory and able to respond verbally to questions, are eligible for inclusion.

排除标准

  • Patients who have not been diagnosed with cancer.
  • Patients with diagnoses made more than 4 weeks ago, who are non-ambulatory, or are already receiving palliative care, are ineligible to participate in the study.

结局指标

主要结局

African Palliative Care Association Palliative Outcome Scale (APCA POS) score

时间窗: 12 weeks

APCA POS: APCA POS measures unpleasant symptoms (pain, worry, other symptoms) on a scale of 0-5 (best to worst). We will compare baseline score to follow up score. An APCA POS score decrease of 3 from baseline will be signficant.

次要结局

  • Hospital Anxiety and Depression Score (HADS)(12 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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