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

This study is currently recruiting participants.
Verified January 2013 by M.D. Anderson Cancer Center
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00511641
First received: August 3, 2007
Last updated: January 23, 2013
Last verified: January 2013
History of Changes
  Purpose

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 Intervention
Ovarian Cancer
 Behavioral: Questionnaire

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

Resource links provided by NLM:

U.S. FDA Resources

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

Primary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]
    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. [ Time Frame: 8 Years ] [ Designated as safety issue: No ]

Estimated Enrollment: 2400
Study Start Date: February 2002
Estimated Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Low Risk OVCA
Patient that is participating in an ovarian cancer (OVCA) screening program.
 Behavioral: Questionnaire
Questionnaires lasting up to 30 minutes.
Other Name: Survey

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.

  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

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

Criteria

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
  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
UT MD 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 M.D. Anderson Cancer Center
  More Information

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

No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00511641     History of Changes
Other Study ID Numbers: ID01-693
Study First Received: August 3, 2007
Last Updated: January 23, 2013
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

Additional relevant MeSH terms:
Ovarian Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
 Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Endocrine System Diseases
Gonadal Disorders

ClinicalTrials.gov processed this record on May 21, 2013