Economic Outcomes in Patients With Stage III Ovarian Cancer Receiving Paclitaxel and Cisplatin on Clinical Trial GOG-172
NCT ID: NCT00477867
Last Updated: 2013-06-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
NA
INTERVENTIONAL
Brief Summary
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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.
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Detailed Description
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* 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.
Conditions
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Study Design
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HEALTH_SERVICES_RESEARCH
Interventions
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quality-of-life assessment
Eligibility Criteria
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Inclusion Criteria
* 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
FEMALE
No
Sponsors
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National Cancer Institute (NCI)
NIH
Gynecologic Oncology Group
NETWORK
Principal Investigators
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Martee L. Hensley, MD
Role: STUDY_CHAIR
Memorial Sloan Kettering Cancer Center
Other Identifiers
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GOG-9905
Identifier Type: -
Identifier Source: secondary_id
CDR0000078639
Identifier Type: -
Identifier Source: org_study_id
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