Quality of Life Associated With a Low-Risk Screening Program for Ovarian Cancer



Status:Active, not recruiting
Conditions:Ovarian Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:50 - Any
Updated:7/11/2018
Start Date:February 12, 2002
End Date:February 2019

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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.

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.

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
We found this trial at
1
site
1515 Holcombe Blvd
Houston, Texas 77030
 713-792-2121
Principal Investigator: Diane C. Bodurka, MD
University of Texas M.D. Anderson Cancer Center The mission of The University of Texas MD...
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mi
from
Houston, TX
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