Phase III Randomized Controlled Trial of a Collaborative Care Intervention to Manage Cancer Related Symptoms in Patients Diagnosed With Hepatobiliary Carcinoma
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 261
- 试验地点
- 1
- 主要终点
- Depression
研究概览
简要总结
The purpose of this study is to test the efficacy of a collaborative care intervention to manage cancer-related symptoms and improve health related quality of life in patients diagnosed with hepatobiliary carcinoma.
详细描述
The study is a collaborative care intervention designed to reduce pain, fatigue, and depressive symptoms and improve overall health related quality of life.
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
- Single (Outcomes Assessor)
盲法说明
Only person evaluating outcomes
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •biopsy, radiological, and/or biological evidence of hepatobiliary carcinoma
- •age 18 years or older
- •fluency in English.
排除标准
- •Exclusion Criteria:
- •current suicidal or homicidal ideation
- •current psychosis or thought disorder
研究组 & 干预措施
Collaborative Care Intervention
Care coordinator facilitates the assessment and treatment of cancer-related symptoms
干预措施: Collaborative Care (Other)
Enhanced Usual Care
Upon evaluation of symptoms the patient will be referred for further assessment or treatment if indicated
干预措施: Enhanced usual Care (Other)
结局指标
主要结局
Depression
时间窗: Change from baseline at 6 and 12 months
Center for Epidemiological Studies-Depression scale
次要结局
- Fatigue(Change from baseline at 6 and 12 months)
研究者
Jennifer Steel
Director, Center for Excellence in Behavioral Medicine
University of Pittsburgh