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

June 20, 2019 updated by: M.D. Anderson Cancer Center
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

1342

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • University of Texas MD Anderson Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Female UT MDACC Patients, over 50 years of age, participating in an ovarian cancer screening program.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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 Names:
  • Survey

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline quality of life data collected, and if/when return to clinic due to abnormal test results.

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

M.D. Anderson Cancer Center

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Diane C. Bodurka, MD, M.D. Anderson Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 12, 2002

Primary Completion (Anticipated)

February 1, 2020

Study Completion (Anticipated)

February 1, 2021

Study Registration Dates

First Submitted

August 3, 2007

First Submitted That Met QC Criteria

August 3, 2007

First Posted (Estimate)

August 6, 2007

Study Record Updates

Last Update Posted (Actual)

June 24, 2019

Last Update Submitted That Met QC Criteria

June 20, 2019

Last Verified

June 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ID01-693

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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