Clinical trial NCT00511641: Quality of Life Associated With a Low-Risk Screening Program for Ovarian Cancer
Official title: Quality of Life Associated With a Low-Risk Screening Program for Ovarian Cancer
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Ovarian Cancer
Keywords: Ovarian Cancer
Cancer Screening
Quality of Life
Questionnaire
Screening
Survey
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2007-08-06
Enrollment: 1342
Sex: FEMALE
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Female UT MDACC Patients, over 50 years of age, participating in an ovarian cancer screening program.

Brief summary: The goal of this research study is to learn more about how women feel about an ovarian cancer screening program that involves getting a blood test to measure CA 125 levels. This includes finding out about women's quality of life and whether they are concerned or worried about their risk of developing cancer. This study also seeks to find out whether elevated CA 125 levels affect participants in terms of cancer worries or concerns.

Detailed description: Participants in this study will be asked to complete several questionnaires. Participants will be able to fill out the questionnaires in the clinic or if necessary, they can complete them at home. Pre-addressed and stamped envelopes will be provided to mail back if they are completed at home. The questionnaires involve quality of life issues, concerns or worries about cancer risk and beliefs about cancer. It will take 30 minutes or less to complete the questionnaires.

The completed questionnaires can be returned to the research nurse or if the participant prefers or they can be returned to the researchers in the self-addressed stamped envelope that is provided.

This is an investigational study. This study will involve 2400 women who are participating in an ovarian cancer screening program. All will be enrolled at MD Anderson.

Eligibility criteria: Inclusion Criteria:

1. Women enrolled on protocol ID01-022

   * Women \> 50 years of age
   * Postmenopausal (\> 12 months amenorrhea)
   * Willingness to return to clinic for annual blood tests, or earlier if indicated
   * Willingness to undergo transvaginal ultrasound if indicated
2. Women who speak and read English

Exclusion Criteria:

1. Women ineligible to be enrolled on protocol ID01-022

   * Prior removal of both ovaries
   * Active non-ovarian malignancy
   * Women who have a history of non-ovarian malignancy will be eligible if they have no persistent or recurrent disease and have not received treatment for \> 12 months. They will not be excluded if they are on tamoxifen.
   * High-risk for ovarian cancer due to familial predisposition as defined by the following:

     * Known mutation in BRCA1 or BRCA2
     * Two first or second degree relatives with either ovarian cancer or pre-menopausal breast cancer
     * Ashkenazi Jewish ethnicity with one first degree or two second degree relatives with pre-menopausal breast or ovarian cancer, or if patient herself has had breast cancer.
2. Women who do not speak or read English

Primary outcomes:
measure: Mean Scores on Each Quality of Life Instrument (Surveys)
timeFrame: Baseline quality of life data collected, and if/when return to clinic due to abnormal test results.
Secondary outcomes:
measure: To find out whether elevated CA 125 levels affect participants in terms of cancer worries or concerns.
timeFrame: 8 Years
Other outcomes:
Locations:
city: Houston
country: United States
facility: University of Texas MD Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Diane C. Bodurka, MD
role: PRINCIPAL_INVESTIGATOR
References: