Genetic and Environmental Risk Assessment for Colorectal Cancer in Healthy Participants

Not Applicable

Completed

• Conditions: Colorectal Cancer

• Registration Number: NCT00087360
• Lead Sponsor: Fox Chase Cancer Center

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2003-11
• Study First Submitted: 2004-07-08
• Study First Submitted QC: 2004-07-09
• Study First Posted: 2004-07-12
• Primary Completion: 2007-05
• Study Completion: 2007-05
• Status Verified: 2013-07
• Last Update Submitted: 2013-07-10
• Last Update Posted: 2013-07-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Colorectal cancer (CRC) screening rates by chart review at 4 months

Secondary Outcome Measures

Name	Time	Method
Knowledge regarding CRC risk by questionnaires at 4 and 12 months
CRC risk perception by questionnaires at 4 and 12 months

Trial Locations

Locations (4)

Fox Chase Cancer Center; 🇺🇸 Philadelphia, Pennsylvania, United States

Kimmel Cancer Center at Thomas Jefferson University - Philadelphia; 🇺🇸 Philadelphia, Pennsylvania, United States

Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support; 🇺🇸 Bethesda, Maryland, United States

Vanderbilt-Ingram Cancer Center at Vanderbilt Medical Center; 🇺🇸 Nashville, Tennessee, United States