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

This study has been completed.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00477867
First received: May 23, 2007
Last updated: February 6, 2009
Last verified: October 2007
History of Changes

May 23, 2007
February 6, 2009
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  • 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 ]
  • 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
Complete list of historical versions of study NCT00477867 on ClinicalTrials.gov Archive Site
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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

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.

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.
Interventional
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Primary Purpose: Health Services Research
Ovarian Cancer
Procedure: quality-of-life assessment
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
40
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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
Female
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No
Contact information is only displayed when the study is recruiting subjects
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NCT00477867
CDR0000078639, GOG-9905
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Gynecologic Oncology Group
National Cancer Institute (NCI)
Study Chair: Martee L. Hensley, MD Memorial Sloan-Kettering Cancer Center
National Cancer Institute (NCI)
October 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP