Cost Utility of Radical Surgery in Ovarian Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 10
- 主要终点
- Cost-utility study
研究概览
简要总结
The purpose of this study is to investigate the medico-economic impact of adherence to INCa (National Cancer Institute) guidelines in ovarian cancer surgery by assessment of outcome in cost per Quality Adjusted Life Years (QALY).
详细描述
This is a prospective, multicenter, comparative and non-randomized study designed to investigate the medico-economic impact of adherence to INCa guidelines in ovarian cancer surgery by assessment of outcome in cost per Quality Adjusted Life Years (QALY).
A cost-utility study will be performed. It will primarily aim to assess the Incremental Cost-Utility Ratio (ICUR) at 3 years of the two treatment strategies of ovarian cancer surgery: adherence to INCa quality indicators versus non-adherence to INCa quality indicators.
Consecutive patients with stage IIIC and IV ovarian, tubal, and primary peritoneal malignancies will be recruited in different health care institutions, including comprehensive cancer centers, university hospitals and private hospitals.
Evaluation of adherence to quality indicators will be assessed retrospectively (once patients have completed the treatment) by two independent experts.
200 patients will be included over a period of 2 years and will be followed for a 3 years period after treatment (every 4 months the first two years and then every 6 months).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- Female
- 接受健康志愿者
- 否
入选标准
- •1. Woman with age ≥ 18 years.
- •2. Newly diagnosed ovarian, tubal or peritoneal malignancies.
- •3. Epithelial histology.
- •4. Stage IIIC or IVA with extrapelvic carcinomatosis according to FIGO classification
- •5. Patients undergoing primary surgery or neoadjuvant chemotherapy.
- •6. Performance Status ≤
- •7. Patient affiliated to a Social Health Insurance in France.
- •8. Patient information and informed consent form signed prior to any study specific procedures.
排除标准
- •1. Benign or borderline tumors.
- •2. Patients with extra-abdominal disease, except for pleural effusion with positive cytology.
- •3. Other malignancy diagnosed in the previous 5 years except skin cancer (other than melanoma).
- •4. 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.
- •5. Patient who has forfeited his/her freedom by administrative or legal award or who is under guardianship.
研究组 & 干预措施
Ovarian cancer
Patient undergoing primary surgery for a newly diagnosed ovarian, tubal or peritoneal malignancies; Stage IIIc or IVa with extrapelvic carcinomatosis according to the International Federation of Gynecology and Obstetrics classification 2014
干预措施: Collection of additional data with questionnaires (Other)
结局指标
主要结局
Cost-utility study
时间窗: 5 years and 6 months
The primary endpoint is defined as cost per Quality-Adjusted Life Year (QALY) at 3 years. Patient utilities will be obtained from the EuroQoL 5D-3L questionnaire.
次要结局
- Rate of institutions adherent to INCa quality indicators(2 years and 6 months)
- Overall Survival(5 years and 6 months)
- Rate of patients "adherent" to INCa quality indicators(2 years and 6 months)
- Progression Free Survival(5 years and 6 months)
- Morbidity(5 years and 6 months)
- Quality of life(5 years and 6 months)
- Budgetary impact on the health insurance budget of these INCa quality indicators on the care management of ovarian cancer patients(5 years and 6 months)