A Single-centre, Non-randomized, Prospective, Open Clinical Trial to Evaluate the Sensitivity of a Number of Clinical and Psychological Outcome Measures for Cancer Patients Being Treated at the Hospital Day Care Unit or (Partially) at Home
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Sensitivity of the questionnaires FACT-G, EQ-5D and MYCaW to measure quality of life in patients being treated at different ambulatory care settings (hospital vs home)
研究概览
简要总结
This pilot study aims to evaluate the sensitivity, variability and responsiveness of a number of predefined clinical and psychological outcome measuring tools in an ambulant cancer treatment setting (home vs. hospital). The measuring tools will be evaluated in two patient cohorts. One cohort is treated as per standard of care at the outpatient hospital, the other cohort is receiving (partial) cancer treatment at home. A second objective is to create a costs inventory representing total costs for an ambulant treated cancer patient.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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)
- •Simultaneous radiotherapy treatment
- •Language barriers or communication difficulties
- •Problematic venous access
- •Known problems with administration of the therapy
研究组 & 干预措施
Intervention
(Partial) Oncological Home Hospitalization
干预措施: Oncological Home Hospitalization (Procedure)
Control
Standard oncological treatment at the hospital day care unit
结局指标
主要结局
Sensitivity of the questionnaires FACT-G, EQ-5D and MYCaW to measure quality of life in patients being treated at different ambulatory care settings (hospital vs home)
时间窗: 8 weeks
Sensitivity will be analysed by comparing average outcome-scores between both groups
Sensitivity of the questionnaire OUT-PATSAT35 to measure satisfaction with the provided care of patients being treated at different ambulatory care settings (hospital vs home)
时间窗: 8 weeks
Sensitivity will be analysed by comparing average outcome-scores between
Sensitivity of the questionnaire HADS to measure anxiety and depression in patients being treated at different ambulatory care settings (hospital vs home)
时间窗: 8 weeks
Sensitivity will be analysed by comparing average outcome-scores between outcome responses within both groups
Sensitivity of the questionnaire Distress Barometer to measure distress in patients being treated at different ambulatory care settings (hospital vs home)
时间窗: 8 weeks
Sensitivity will be analysed by comparing average outcome-scores between outcome responses within both groups
Sensitivity of a self-designed questionnaire to measure the safety feeling of patients being treated at different ambulatory care settings (hospital vs home)
时间窗: 8 weeks
Sensitivity will be analysed by comparing average outcome-scores between outcome responses within both groups
次要结局
- Costs inventory representing total costs for an ambulant treated cancer patient(8 weeks)
研究者
Koen Van Eygen
Dr
General Hospital Groeninge