NCT02204111已完成不适用
Patient Directed Intervention Towards a Multidimensional Recommendation Guideline to Improve the Quality of Life for Patients With Soft Tissue Sarcoma Under Palliative Treatment With Trabectedin
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- GWT-TUD GmbH
- 入组人数
- 77
- 试验地点
- 7
- 主要终点
- Health related QoL, measured by total score of FACT-G
研究概览
简要总结
The primary objective of the study is to compare quality of life (QoL) between patients suffering from soft tissue sarcoma, receiving a multidimensional intervention with those receiving standard treatment.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
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
- •Diagnosis of advanced or metastatic soft tissue sarcoma
- •Treatment with trabectedin in an in-label prescription
- •Age at least 18 years (inclusive) at the first visit
- •Patients with a life expectancy of at least 6 months
- •The informed consent form must be signed before any study specific tests or procedures are done
- •Confirmation of the subject's health insurance coverage prior to the first visit
- •Ability to understand and follow study-related instructions
排除标准
- •ECOG PS >2
- •Estimated life expectancy of less than 6 months
- •Patients with STS not receiving trabectedin
- •Contraindications according to the local SmPC of Yondelis®
- •Subject is in custody by order of an authority or a court of law
- •Exclusion periods from other studies or simultaneous participation in other clinical studies
- •Previous assignment to treatment during this study
- •Close affiliation with the investigator (e.g. a close relative) or persons working at the study site
- •Subject is an employee of GWT-TUD GmbH or Pharma Mar S.A.
- •Criteria which in the opinion of the investigator preclude participation for scientific reasons, for reasons of compliance, or for reasons of the subject's safety
结局指标
主要结局
Health related QoL, measured by total score of FACT-G
时间窗: change to baseline at 9 weeks
assessed by the patient using standard questionnaire (FACT-G) via tablet-PC
次要结局
- Anxiety and depression (HADS)(baseline, 9, 21, 35 and 61 weeks)
- Dimensions of QoL (scales of FACT-G)(baseline, 3, 6, 9, 21, 35 and 61 weeks)
- Intensity of pain and pain related interference (BPI)(baseline, 9, 21, 35 and 61 weeks)
- progression free survival(baseline up to 61 weeks)
- Overall survival(baseline up to 61 weeks)
- Satisfaction with care (IN-PATSAT32)(baseline, 9, 21, 35 and 61 weeks)
- Anorexia and cachexia related impact on QoL (FAACT)(baseline, 9, 21, 35 and 61 weeks)
- Severity of cancer-related symptoms (MDASI)(baseline, 3, 6, 9, 21, 35 and 61 weeks)
研究者
研究点 (7)
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