Economic Outcomes in Patients With Stage III Ovarian Cancer Receiving Paclitaxel and Cisplatin on Clinical Trial GOG-172
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Ovarian Cancer |
Procedure: quality-of-life assessment |
| Study Type: | Interventional |
| Study Design: | Primary Purpose: Health Services Research |
| Official Title: | 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 |
- Feasibility of collecting data on medical resource utilization and costs incurred in the care of patients with stage III ovarian cancer [ Designated as safety issue: No ]
- Feasibility of collecting data on resource utilization incurred outside GOG institutions [ Designated as safety issue: No ]
- Work load required to collect this data, in terms of mean number of hours required to complete medical resource utilization forms [ Designated as safety issue: No ]
| Estimated Enrollment: | 40 |
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.
Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study within 1 year.
Eligibility| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
- Diagnosis of stage III ovarian cancer
- Concurrent enrollment on clinical trial GOG-172 required
PATIENT CHARACTERISTICS:
Age:
- Not specified
Performance status:
- GOG 0-3
Life expectancy:
- Not specified
Other:
- Able to communicate in English or Spanish
PRIOR CONCURRENT THERAPY:
Biologic therapy
- Not specified
Chemotherapy
- Not specified
Endocrine therapy
- Not specified
Radiotherapy
- Not specified
Surgery
- Not specified
Contacts and Locations More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00477867 History of Changes |
| Other Study ID Numbers: | CDR0000078639, GOG-9905 |
| Study First Received: | May 23, 2007 |
| Last Updated: | February 6, 2009 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Cancer Institute (NCI):
|
stage III ovarian epithelial cancer |
Additional relevant MeSH terms:
|
Ovarian Neoplasms Endocrine Gland Neoplasms Neoplasms by Site Neoplasms Ovarian Diseases Genital Neoplasms, Female Urogenital Neoplasms Adnexal Diseases Genital Diseases, Female Endocrine System Diseases Gonadal Disorders Cisplatin |
Paclitaxel Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Radiation-Sensitizing Agents Physiological Effects of Drugs Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action Antineoplastic Agents, Phytogenic |
ClinicalTrials.gov processed this record on May 16, 2013