Cost Utility Analysis in Recurrent Ovarian Cancer
This study has been withdrawn prior to enrollment.
Sponsor:
M.D. Anderson Cancer Center
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00813254
First received: December 22, 2008
Last updated: April 18, 2012
Last verified: April 2012
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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:
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| Ages Eligible for Study: | Child, Adult, Senior |
| 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00813254
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:
| 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 September 23, 2016