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Economic Outcomes in Patients With Stage III Ovarian Cancer Receiving Paclitaxel and Cisplatin on Clinical Trial GOG-172

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

Status
Withdrawn
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00477867
Enrollment
0
Registered
2007-05-24
Start date
Unknown
Completion date
Unknown
Last updated
2013-06-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ovarian Cancer

Keywords

stage III ovarian epithelial cancer

Brief summary

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.

Detailed description

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.

Interventions

PROCEDUREquality-of-life assessment

Sponsors

National Cancer Institute (NCI)
CollaboratorNIH
Gynecologic Oncology Group
Lead SponsorNETWORK

Study design

Primary purpose
HEALTH_SERVICES_RESEARCH

Eligibility

Sex/Gender
FEMALE
Healthy volunteers
No

Inclusion criteria

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

Design outcomes

Primary

MeasureTime frame
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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026