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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Withdrawn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
Gynecologic Oncology Group
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional health services research trial for Ovarian Cancer focused on measuring stage III ovarian epithelial cancer

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

    First Posted
    May 23, 2007
    Last Updated
    June 7, 2013
    Sponsor
    Gynecologic Oncology Group
    Collaborators
    National Cancer Institute (NCI)
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    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
    undefined (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    undefined (undefined)

    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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