A Single-center, Open Randomized Controlled Clinical Trial to Evaluate the Quality and Cost of (Partial) Oncological Home-hospitalization Compared to Standard Ambulatory Hospital Care
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 148
- 试验地点
- 2
- 主要终点
- Change in Patient-reported Quality of Life - Cancer specific
研究概览
简要总结
Oncological home-hospitalization might be a patient-centred, cost-effective approach to deal wiht the current challenges in cancer healthcare.
The primary aim of this clinical trial is to evaluate patient-reported quality of life of patients receiving (partial) oncological home-hospitalization and to compare this outcome with patients receiving standard ambulatory hospital care.
Secondary endpoints that will be evaluated and compared between both randomized groups are: Quality of life related endpoints (i.e. distress, depression & anxiety and general health-related quality of life); Costs; Safety; patients' reported Satisfaction & Preferences and Efficiency for the hospital day care unit.
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
- 否
入选标准
- •Starting new oncological treatment at the outpatient hospital
- •Living within 30 minutes of drive from the hospital
排除标准
- •Important comorbidity (ECOG > 2)
- •Life expectancy < 6 months
- •Simultaneous treatment with radiotherapy
- •Taking part in clinical trial with any Investigational Medicinal Product
- •Language barriers or communication difficulties
- •Problematic venous access
结局指标
主要结局
Change in Patient-reported Quality of Life - Cancer specific
时间窗: Inquiry at baseline, 4 weeks, 8 weeks and 12 weeks
Evaluation of the change of patient-reported quality of life for both study arms using FACT-G (Functional Assessment of Cancer Therapy - General) questionnaire.
Change in Patient-reported Quality of Life - General
时间窗: Inquiry at baseline, 4 weeks, 8 weeks and 12 weeks
Evaluation of the change of patient-reported quality of life for both study arms using EQ-5D (EuroQol 5 dimensions) questionnaire.
次要结局
- Number of grade 3/4 toxicities according to CTCAE v4.0(Inquiry at baseline, 4 weeks, 8 weeks and 12 weeks)
- Patient-reported Distress(Inquiry at baseline and 12 weeks)
- Preference using a self-designed patient-reported questionnaire(Inquiry at baseline and 12 weeks)
- Cost evaluation using study-specific costs questionnaire(12 weeks)
- Wait times for administration of treatment at the oncology day care unit.(12 weeks)
- Patient-reported Depression & Anxiety(Inquiry at baseline and 12 weeks)
- Patient-reported Safety(Inquiry at baseline, 4 weeks, 8 weeks and 12 weeks)
- Satisfaction using OUT-PATSAT35 CT questionnaire(Inquiry at baseline and 12 weeks)
研究者
Koen Van Eygen
Head of Oncology
General Hospital Groeninge