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

Sponsored by:	M.D. Anderson Cancer Center
Information provided by:	M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:	NCT00511641

Purpose

Primary Objectives:

Examine quality of life over time for women enrolled in an ovarian cancer screening program (ID01-022)
Examine quality of life in the subset of women enrolled in ID01-022 who need a repeat CA 125 test and/or receive a transvaginal ultrasound and referral to gynecologic oncologist
Collect costs associated with an ovarian cancer screening program for low-risk post-menopausal women

Condition	Intervention
Ovarian Cancer	Behavioral: Questionnaire

MedlinePlus related topics: Cancer Ovarian Cancer

U.S. FDA Resources

Study Type:	Observational
Study Design:	Case-Only, Prospective
Official Title:	Quality of Life Associated With a Low-Risk Screening Program for Ovarian Cancer

Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:

To learn more about how women feel about an ovarian cancer screening program that involves getting a blood test to measure CA 125 levels. [ Time Frame: 8 Years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To find out whether elevated CA 125 levels affect participants in terms of cancer worries or concerns. [ Time Frame: 8 Years ] [ Designated as safety issue: No ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	2400
Study Start Date:	February 2002
Estimated Primary Completion Date:	February 2010 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
1 Patient that is participating in an ovarian cancer screening program.	Behavioral: Questionnaire Questionnaires lasting up to 30 minutes.

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 M.D. Anderson.

Eligibility

Ages Eligible for Study:	50 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes
Sampling Method:	Non-Probability Sample

Study Population

Patient that is participating in an ovarian cancer screening program.

Criteria

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.
Women who do not speak or read English

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00511641

Contacts

Contact: Charlotte C. Sun, DrPH

713-745-4380

Locations

United States, Texas
U.T.M.D. Anderson Cancer Center	Recruiting
Houston, Texas, United States, 77030
Principal Investigator: Diane C. Bodurka, MD

Sponsors and Collaborators

M.D. Anderson Cancer Center

Investigators

Principal Investigator:

Diane C. Bodurka, MD

U.T.M.D. Anderson Cancer Center

More Information

MD Anderson Cancer Center This link exits the ClinicalTrials.gov site

Responsible Party:	U.T.M.D. Anderson Cancer Center ( Diane C. Bodurka, MD/Associate Professor )
Study ID Numbers:	ID01-693
Study First Received:	August 3, 2007
Last Updated:	October 22, 2008
ClinicalTrials.gov Identifier:	NCT00511641
Health Authority:	United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:

Ovarian Cancer
Cancer Screening
Quality of Life

Questionnaire
Screening
Survey

Study placed in the following topic categories:

Genital Diseases, Female
Ovarian cancer
Ovarian Neoplasms
Gonadal Disorders
Genital Neoplasms, Female
Quality of Life

Endocrine System Diseases
Urogenital Neoplasms
Endocrinopathy
Ovarian Diseases
Endocrine Gland Neoplasms

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Adnexal Diseases

ClinicalTrials.gov processed this record on January 16, 2009