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Clinical Trials/NCT00477867
NCT00477867WithdrawnNot Applicable

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

Gynecologic Oncology Group0 sitesStarted: May 24, 2007Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Withdrawn
Primary Endpoint
Feasibility of collecting data on medical resource utilization and costs incurred in the care of patients with stage III ovarian cancer

Study Overview

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.

Study Design

Study Type
Interventional
Primary Purpose
Health Services Research

Eligibility Criteria

Sex
Female
Accepts Healthy Volunteers
No

Inclusion Criteria

  • DISEASE CHARACTERISTICS:
  • Diagnosis of stage III ovarian cancer
  • Concurrent enrollment on clinical trial GOG-172 required
  • PATIENT CHARACTERISTICS:
  • Not specified
  • Performance status:
  • Life expectancy:
  • Not specified
  • Able to communicate in English or Spanish
  • PRIOR CONCURRENT THERAPY:
  • Biologic therapy
  • Not specified
  • Chemotherapy
  • Not specified
  • Endocrine therapy
  • Not specified
  • Radiotherapy
  • Not specified
  • Not specified

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

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 Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Network

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