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

Sponsor

M.D. Anderson Cancer Center (Other)

Overall Status

Unknown status

CT.gov ID

NCT00511641

Collaborator

National Cancer Institute (NCI) (NIH)

1,342

Enrollment

Location

227.6

Anticipated Duration (Months)

5.9

Patients Per Site Per Month

Study Details

Study Description

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	Phase
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.

Study Design

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 :

Feb 12, 2002

Anticipated Primary Completion Date :

Feb 1, 2020

Anticipated Study Completion Date :

Feb 1, 2021

Arms and Interventions

Arm	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

Arm

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

Outcome Measures

Primary Outcome Measures

Mean Scores on Each Quality of Life Instrument (Surveys) [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

To find out whether elevated CA 125 levels affect participants in terms of cancer worries or concerns. [8 Years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

50 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

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

Women who speak and read English

Exclusion Criteria:

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.