Assessing Economic Outcomes in Women With Stage III Ovarian Cancer Treated With Intravenous Paclitaxel and Cisplatin v. Intravenous Paclitaxel, Intraperitoneal Cisplatin and Intraperitoneal Paclitaxel on GOG #172: A Feasibility Study of Assessing Costs and Medical Resource Use
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- Feasibility of collecting data on medical resource utilization and costs incurred in the care of patients with stage III ovarian cancer
研究概览
简要总结
RATIONALE: Gathering information about patients with ovarian cancer over time may help doctors learn more about a patient's use of medical services and the cost of these services.
PURPOSE: This clinical trial is collecting information about the patient's health and use of medical resources over time in patients with stage III ovarian cancer receiving paclitaxel and cisplatin on clinical trial GOG-172.
详细描述
OBJECTIVES:
- Determine the feasibility of collecting data on medical resource utilization and costs incurred in the care of patients with stage III ovarian cancer treated with intravenous (IV) paclitaxel and cisplatin vs IV paclitaxel, intraperitoneal (IP) paclitaxel, and IP cisplatin on a randomized, controlled clinical trial.
- Determine the feasibility of collecting data on resource utilization incurred outside GOG institutions through the use of patient diaries.
- Assess the work load required to collect this data, in terms of mean number of hours required to complete medical resource utilization forms.
OUTLINE: Data on medical resource units consumed (including length of hospital stay, length of time using operating room, units of drugs and blood products administered, number of diagnostic tests received, and number of physician visits needed) are collected on all patients.
Quality of life is assessed prior to randomization on clinical trial GOG-172, prior to the fourth course of chemotherapy, after the sixth course of chemotherapy, and at 3 months and 6 months after the sixth course of chemotherapy. Patients complete diaries throughout treatment with chemotherapy and for 12 months after treatment.
Data collected are used for analysis of economic impact, quality of life, neurotoxicity, and sociologic characteristics associated with these treatment regimens.
研究设计
- 研究类型
- Interventional
- 主要目的
- Health Services Research
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Diagnosis of stage III ovarian cancer
- •Concurrent enrollment on clinical trial GOG-172 required
- •PATIENT CHARACTERISTICS:
- •Not specified
- •Performance status:
- •Life expectancy:
- •Not specified
- •Able to communicate in English or Spanish
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- •Not specified
- •Chemotherapy
- •Not specified
- •Endocrine therapy
- •Not specified
- •Radiotherapy
- •Not specified
- •Not specified
排除标准
- 未提供
结局指标
主要结局
Feasibility of collecting data on medical resource utilization and costs incurred in the care of patients with stage III ovarian cancer
Feasibility of collecting data on resource utilization incurred outside GOG institutions
Work load required to collect this data, in terms of mean number of hours required to complete medical resource utilization forms
次要结局
未报告次要终点
