Cost Utility Analysis in Recurrent Ovarian Cancer - Full Text View

Sponsored by:	M.D. Anderson Cancer Center
Information provided by:	M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:	NCT00813254

Purpose

Primary Objective:

1. To longitudinally measure quality of life and sexual functioning and assess symptoms in women with recurrent, platinum-resistant ovarian cancer receiving multiple second-line treatment regimens

Secondary Objectives:

To determine costs associated with receiving multiple second-line treatments for ovarian cancer
To determine quality-adjusted life years for women receiving second-line treatment for ovarian cancer
To perform a cost-utility analysis for second-line therapies in women with recurrent, platinum-resistant ovarian cancer

Condition	Intervention
Ovarian Cancer	Behavioral: Questionnaire

MedlinePlus related topics: Cancer Caregivers Ovarian Cancer

Drug Information available for: BaseLine

U.S. FDA Resources

Study Type:	Observational
Study Design:	Cohort, Retrospective
Official Title:	Quality of Life and Cost Utility Analysis in the Treatment of Recurrent, Platinum-Resistant Ovarian Cancer

Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:

To study the quality of life and sexual functioning of women with platinum-resistant ovarian cancer as they receive other treatments for the disease. [ Time Frame: 2 Years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To study the costs for chemotherapy treatments, other medical expenses, and treatment-related expenses that are not medical. [ Time Frame: 2 Years ] [ Designated as safety issue: No ]
To study if and how these patients' caregivers feel the status of these patients' health may have affected the caregivers' productivity at work and at home. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
To review any symptoms these patients may experience related to the cancer or treatment. [ Time Frame: 2 Years ] [ Designated as safety issue: No ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	41
Study Start Date:	December 2008
Estimated Primary Completion Date:	December 2010 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
Ovarian Cancer Study participants with Ovarian Cancer that is considered to be "platinum-resistant."	Behavioral: Questionnaire Questionnaires 1 - 5 will be completed on Day 1 of study as a Baseline.

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Eligibility

Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No
Sampling Method:	Probability Sample

Study Population

Study participants that were diagnosed with Ovarian Cancer that are now "Platinum-Resistant."

Criteria

Inclusion Criteria:

Patients with recurrent, platinum-resistant epithelial ovarian cancer who are beginning any second-line treatment
Patients must be English-speaking
Patients must be able to read and write English
Patients receiving all chemotherapy at MD Anderson Cancer Center

Exclusion Criteria:

Patients with non-epithelial ovarian cancers including sex-cord stromal tumors, germ cell tumors, low-grade tumors, and metastatic disease to the ovary
Patients who are receiving protocol therapy
Patients who have had a prior diagnosis of invasive cancer at other sites (excluding basal cell carcinoma of the skin)
Patients who are receiving radiation therapy as a treatment modality

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00813254

Contacts

Contact: Michael M Frumovitz, MD

713-792-9599

Locations

United States, Texas
The University of Texas M.D. Anderson Cancer Center	Recruiting
Houston, Texas, United States, 77030

Sponsors and Collaborators

M.D. Anderson Cancer Center

Investigators

Principal Investigator:

Michael M Frumovitz, MD

M.D. Anderson Cancer Center

More Information

The University of Texas M.D.Anderson Cancer Center This link exits the ClinicalTrials.gov site

Responsible Party:	U.T.M.D. Anderson Cancer Center ( Michael M. Frumovitz, MD/Assistant Professor )
Study ID Numbers:	2007-0611
Study First Received:	December 22, 2008
Last Updated:	December 22, 2008
ClinicalTrials.gov Identifier:	NCT00813254
Health Authority:	United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:

Platinum-Resistant Ovarian Cancer
Platinum-based chemotherapy
Ovarian Cancer
Ovary
Epithelial ovarian cancer
Quality of Life

Multiple second-line treatments
Cost Utility Analysis
Sexual functioning of women
Questionnaire
Patients' caregivers
Caregivers' productivity

Study placed in the following topic categories:

Ovarian cancer
Ovarian Neoplasms
Gonadal Disorders
Genital Neoplasms, Female
Endocrine System Diseases
Quality of Life
Urogenital Neoplasms

Ovarian Diseases
Ovarian epithelial cancer
Recurrence
Genital Diseases, Female
Endocrinopathy
Endocrine Gland Neoplasms

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Adnexal Diseases

ClinicalTrials.gov processed this record on January 13, 2009