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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00511641
Recruitment Status : Active, not recruiting
First Posted : August 6, 2007
Last Update Posted : June 24, 2019
National Cancer Institute (NCI)
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

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.

Condition or disease Intervention/treatment
Ovarian Cancer Behavioral: Questionnaire

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.

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Study Type : Observational
Actual Enrollment : 1342 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Quality of Life Associated With a Low-Risk Screening Program for Ovarian Cancer
Actual Study Start Date : February 12, 2002
Estimated Primary Completion Date : February 2020
Estimated Study Completion Date : February 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ovarian Cancer

Group/Cohort Intervention/treatment
Low Risk OVCA
Patient that is participating in an ovarian cancer (OVCA) screening program.
Behavioral: Questionnaire
Questionnaires lasting up to 30 minutes.
Other Name: Survey

Primary Outcome Measures :
  1. Mean Scores on Each Quality of Life Instrument (Surveys) [ Time Frame: Baseline quality of life data collected, and if/when return to clinic due to abnormal test results. ]
    Descriptive, written, self-report, quality of life instruments used.

Secondary Outcome Measures :
  1. To find out whether elevated CA 125 levels affect participants in terms of cancer worries or concerns. [ Time Frame: 8 Years ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Female UT MDACC Patients, over 50 years of age, participating in an ovarian cancer screening program.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00511641

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United States, Texas
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
National Cancer Institute (NCI)
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Principal Investigator: Diane C. Bodurka, MD M.D. Anderson Cancer Center

Additional Information:
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Responsible Party: M.D. Anderson Cancer Center Identifier: NCT00511641     History of Changes
Other Study ID Numbers: ID01-693
First Posted: August 6, 2007    Key Record Dates
Last Update Posted: June 24, 2019
Last Verified: June 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by M.D. Anderson Cancer Center:
Ovarian Cancer
Cancer Screening
Quality of Life
Additional relevant MeSH terms:
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Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Endocrine Gland Neoplasms
Neoplasms by Site
Ovarian Diseases
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Adnexal Diseases
Genital Diseases, Female
Endocrine System Diseases
Gonadal Disorders