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

Ovarian Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00511641
• Other study ID #: ID01-693
• Status: Active, not recruiting
• Start date: February 12, 2002
• Est. completion date: February 2021

Study information

• Verified date: June 2019
• Source: M.D. Anderson Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1342
• Est. completion date: February 2021
• Est. primary completion date: February 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Ovarian Epithelial
• Ovarian Cancer
• Ovarian Neoplasms

Intervention

Behavioral:
• Questionnaire
Questionnaires lasting up to 30 minutes.

Locations

Country	Name	City	State
United States	University of Texas MD Anderson Cancer Center	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
M.D. Anderson Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean Scores on Each Quality of Life Instrument (Surveys)	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	To find out whether elevated CA 125 levels affect participants in terms of cancer worries or concerns.		8 Years

External Links

•   University of Texas MD Anderson Cancer Center Website