Cost Utility Analysis in Recurrent Ovarian Cancer - Full Text View

Sponsor:	M.D. Anderson Cancer Center
Information provided by (Responsible Party):	M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:	NCT00813254

Purpose

The goal of this research study is to learn about the quality of life and sexual functioning of women with platinum-resistant ovarian cancer as they receive other treatments for the disease.

Researchers will study the costs for chemotherapy treatments, other medical expenses, and treatment-related expenses that are not medical. Researchers will also review any symptoms these patients may experience related to the cancer or treatment.

In addition, researchers want to learn if and how these patients' caregivers feel the status of these patients' health may have affected the caregivers' productivity at work and at home.

Condition	Intervention
Ovarian Cancer	Behavioral: Questionnaire

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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Caregivers Ovarian Cancer

U.S. FDA Resources

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

Primary Outcome Measures:

Mean Score for the FACT-O instrument [ Time Frame: First 2 days of chemotherapy cycles ] [ Designated as safety issue: No ]
Participants will complete questionnaires 1 - 5 at baseline and Day 1 of each of their chemotherapy cycles.

Enrollment:	0
Study Start Date:	December 2008
Study Completion Date:	January 2011
Primary Completion Date:	January 2011 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
Questionnaire Longitudinal measure of QOL, sexual functioning and symptoms in women with recurrent, platinum-resistant ovarian cancer receiving multiple second-line treatment regimens	Behavioral: Questionnaire Questionnaires 1 - 5 will be completed on Day 1 of study as a Baseline. Other Name: Survey

Show Detailed Description

Eligibility

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

Study Population

Female 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

Locations

United States, Texas
UT MD Anderson Cancer Center
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

Additional Information:

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

No publications provided

Responsible Party:	M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:	NCT00813254 History of Changes
Other Study ID Numbers:	2007-0611
Study First Received:	December 22, 2008
Last Updated:	April 18, 2012
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
Cost Utility Analysis
Sexual functioning
Questionnaire
Caregiver

Additional relevant MeSH terms:

Ovarian Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases

Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders

ClinicalTrials.gov processed this record on May 23, 2012