NCT03329755已完成不适用
Optimization of the Patient Care Pathway in Immuno-oncology
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 142
- 试验地点
- 4
- 主要终点
- Average length of administrative stay in the hospital
研究概览
简要总结
This study compares the care pathway of melanoma patients treated by immunotherapy in two ambulatory care structures. The aim is to measure if a care structure specialized in immuno-oncology could rationalize the care of patients.
This protocol will be based on two different follow-up during the treatment period:
- dedicated and coordinated e-follow-up (IUCT-O in Toulouse)
- standard follow-up (University Hospital Center in Bordeaux)
Patients will be followed from the first cycle of immunotherapy until 3 months after the initiation treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 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
- •Patient with advanced (unresectable melanoma (stage III)) or metastatic (stage IV) melanoma and starting an Immune Checkpoint Inhibitor treatment (Monotherapy or Combination Therapy)
- •Patient starting first cycle of Immune Checkpoint Inhibitor treatment in an ambulatory care structure
- •Treatment which can be delayed for 7 days or more
- •Age > or = 18 years old
- •Patient with a phone and/or computer equipment
- •Patient affiliated to the french social security system
- •Patient must provide written informed consent prior to any study-specific procedure or assessment
排除标准
- •Patient with diagnosis other than advanced melanoma
- •Patient who must receive a treatment other than Immune Checkpoint Inhibitor
- •Treatment administered during a conventional hospital stay (period of more than 24 hours)
- •Patient with no caregiver
- •Pregnant or breastfeeding women
- •Any psychological, familial, geographic or social situation, according to the judgment of investigator, potentially preventing the provision of informed consent or compliance to study procedure
- •Patient protected by law
结局指标
主要结局
Average length of administrative stay in the hospital
时间窗: 3 months by patient
次要结局
- Frequency of web interface completion (Experimental arm only)(3 months by patient)
- Number of cancelled or delayed hospital stay(3 months by patient)
- Patient quality of life using the Quality of Life Questionnaire Core 30 (QLQ-C30)(3 months by patient)
- Rate of reclassified alerts after intervention of nurse (Experimental arm only)(3 months by patient)
- Correlation between the day hospital stay and the patient general health(3 months by patient)
- Treatment response rate at 3 months(3 months by patient)
- Patient satisfaction to the e-follow-up (Experimental arm only)(3 months by patient)
研究者
研究点 (4)
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