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Providing Genetic And Environmental Cancer Risk Assessment In Primary Care
RATIONALE: Evaluating the knowledge and attitudes of healthy participants toward a new diet and gene test for colorectal cancer risk may help doctors improve acceptance of colorectal cancer screening. PURPOSE: This clinical trial is studying the knowledge and attitudes of healthy participants toward genetic and environmental risk assessment for colorectal cancer.
OBJECTIVES: Part 1 * Determine the willingness of healthy participants to enroll in a genetic and environmental risk assessment for colorectal cancer. * Determine the impact of decision counseling on knowledge and attitudes about genetic and environmental risk assessment (GERA) and colorectal cancer screening in these participants. * Determine participants' understanding of GERA. * Determine participants' response to GERA results. Part 2 * Determine awareness of, and interest in, diet and genetic assessment for colorectal cancer among healthy participants at average risk for colorectal cancer who have not undergone regular colon cancer screening. * Determine participants' level of knowledge of this assessment. * Determine participants' rate of acceptance into this study. OUTLINE: This is a 2-part pilot study. * Part 1: Participants complete a baseline questionnaire on attitudes, beliefs, and knowledge about colorectal cancer (CRC), CRC screening, and diet and genetic testing for colorectal cancer risk. Two-four weeks later, participants are educated about CRC screening options and undergo genetic and environmental risk assessment (GERA) decision counseling about the methylene tetrahydrofolate reductase (MTHFR) gene and dietary folate intake. Participants who decide to undergo GERA undergo blood testing for MTHFR polymorphisms and folate levels. Participants whose blood tests indicate low folate levels are further counseled about dietary folate intake. * Part 2: Participants complete a questionnaire on attitudes, beliefs, and knowledge about CRC, CRC screening, and diet and genetic testing for colorectal cancer risk. Participants in part 1 are followed at 1 week, 1 month, and then at 6 months. PROJECTED ACCRUAL: A total of 110 participants (60 for part 1 and 50 for part 2) will be accrued for this study.
Age
50 - 74 years
Sex
ALL
Healthy Volunteers
Yes
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support
Bethesda, Maryland, United States
Kimmel Cancer Center at Thomas Jefferson University - Philadelphia
Philadelphia, Pennsylvania, United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States
Vanderbilt-Ingram Cancer Center at Vanderbilt Medical Center
Nashville, Tennessee, United States
Start Date
November 1, 2003
Primary Completion Date
May 1, 2007
Completion Date
May 1, 2007
Last Updated
July 11, 2013
counseling intervention
OTHER
physiologic testing
OTHER
evaluation of cancer risk factors
PROCEDURE
Lead Sponsor
Fox Chase Cancer Center
Collaborators
NCT06696768
NCT04704661
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
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