Cost of Cancer Risk Management in Women at Elevated Genetic Risk for Ovarian Cancer Who Participated on GOG-0199
Recruitment status was Not yet recruiting
RATIONALE: Gathering information about women at elevated genetic risk for ovarian cancer may help doctors learn more about risk reduction procedures and the cost of these procedures.
PURPOSE: This clinical trial is collecting information about types of treatment and the cost of these procedures.
Fallopian Tube Cancer
Hereditary Breast/Ovarian Cancer (brca1, brca2)
Primary Peritoneal Cavity Cancer
Other: medical chart review
Other: study of socioeconomic and demographic variables
Procedure: disease screening
Procedure: evaluation of cancer risk factors
Procedure: genitourinary surgical procedure
Procedure: psychosocial assessment and care
Procedure: quality-of-life assessment
|Study Design:||Primary Purpose: Health Services Research|
|Official Title:||A Comparative Effectiveness Study of Cancer Risk Management for Women at Elevated Genetic Risk of Ovarian Cancer|
- Cost-effectiveness of RRSO versus OCS [ Designated as safety issue: No ]
|Study Start Date:||October 2012|
|Estimated Primary Completion Date:||October 2013 (Final data collection date for primary outcome measure)|
- To estimate the cost-effectiveness, defined as cost per quality-adjusted life-year saved, of risk-reducing salpingo-oophorectomy (RRSO) versus ovarian cancer screening (OCS) for women at elevated genetic risk of ovarian cancer over a five-year period, using data from GOG-0199 to model survival.
- To estimate the cost-effectiveness, defined as cost per quality-adjusted life-year saved, of RRSO versus OCS for women at elevated genetic risk of ovarian cancer over a lifetime, using stage-specific cohorts and population-based data to model long-term survival. (Exploratory)
- To use value of information (VOI) methodology to set future research priorities aimed at developing evidence-based approaches to the management of women who are at elevated genetic risk of ovarian cancer. (Exploratory)
OUTLINE: Outcome data, such as incidence and stage at diagnosis of ovarian, fallopian tube, and peritoneal cancers; number and timing of screening and serum tests performed; number and timing of pelvic ultrasounds performed; surgical procedures performed; cancer-specific and overall survival (if available); and the incidence, type, and grade of significant adverse events, are collected from the Gynecologic Oncology Group (GOG)-0199 records and analyzed. Cost of each medical intervention is also estimated.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01445275
|Study Chair:||Laura J. Havrilesky, MD||Duke Cancer Institute|