Economic Outcomes in Patients With Stage III Ovarian Cancer Receiving Paclitaxel and Cisplatin on Clinical Trial GOG-172
Primary Purpose
Ovarian Cancer
Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
quality-of-life assessment
Sponsored by
About this trial
This is an interventional health services research trial for Ovarian Cancer focused on measuring stage III ovarian epithelial cancer
Eligibility 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
Sites / Locations
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Full Information
NCT ID
NCT00477867
First Posted
May 23, 2007
Last Updated
June 7, 2013
Sponsor
Gynecologic Oncology Group
Collaborators
National Cancer Institute (NCI)
1. Study Identification
Unique Protocol Identification Number
NCT00477867
Brief Title
Economic Outcomes in Patients With Stage III Ovarian Cancer Receiving Paclitaxel and Cisplatin on Clinical Trial GOG-172
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
Study Type
Interventional
2. Study Status
Record Verification Date
October 2007
Overall Recruitment Status
Withdrawn
Why Stopped
Trial was never activated
Study Start Date
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Primary Completion Date
undefined (undefined)
Study Completion Date
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3. Sponsor/Collaborators
Name of the Sponsor
Gynecologic Oncology Group
Collaborators
National Cancer Institute (NCI)
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ovarian Cancer
Keywords
stage III ovarian epithelial cancer
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
quality-of-life assessment
Primary Outcome Measure Information:
Title
Feasibility of collecting data on medical resource utilization and costs incurred in the care of patients with stage III ovarian cancer
Title
Feasibility of collecting data on resource utilization incurred outside GOG institutions
Title
Work load required to collect this data, in terms of mean number of hours required to complete medical resource utilization forms
10. Eligibility
Sex
Female
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Martee L. Hensley, MD
Organizational Affiliation
Memorial Sloan Kettering Cancer Center
Official's Role
Study Chair
12. IPD Sharing Statement
Learn more about this trial
Economic Outcomes in Patients With Stage III Ovarian Cancer Receiving Paclitaxel and Cisplatin on Clinical Trial GOG-172
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