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

50 Years
Open (Enrolling)
Ovarian Cancer

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Trial Information

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

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

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

- 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

Type of Study:


Study Design:

Observational Model: Case-Only, Time Perspective: Prospective

Outcome Measure:

Mean Scores on Each Quality of Life Instrument (Surveys)

Outcome Description:

Descriptive, written, self-report, quality of life instruments used.

Outcome Time Frame:

Baseline quality of life data collected, and if/when return to clinic due to abnormal test results.

Safety Issue:


Principal Investigator

Diane C. Bodurka, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

M.D. Anderson Cancer Center


United States: Institutional Review Board

Study ID:




Start Date:

February 2002

Completion Date:

Related Keywords:

  • Ovarian Cancer
  • Ovarian Cancer
  • Cancer Screening
  • Quality of Life
  • Questionnaire
  • Screening
  • Survey
  • Ovarian Neoplasms



UT MD Anderson Cancer Center Houston, Texas  77030