Completed

Genetic and Environmental Risk Assessment for Colorectal Cancer in Healthy Participants

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What is being tested

counseling intervention

+ physiologic testing
+ evaluation of cancer risk factors
Other
Procedure
Who is being recruted

Colorectal Cancer

From 50 to 74 Years
How is the trial designed

Screening Study

Interventional
Study Start: November 2003

Summary

Principal SponsorFox Chase Cancer Center
Last updated: July 11, 2013
Sourced from a government-validated database.Claim as a partner
Study start date: November 1, 2003Actual date on which the first participant was enrolled.

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.

Official TitleProviding Genetic And Environmental Cancer Risk Assessment In Primary Care 
Principal SponsorFox Chase Cancer Center
Last updated: July 11, 2013
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details
Screening Study
Screening studies test new methods to find diseases or risk factors early—before any symptoms appear. This helps catch health issues sooner, when they may be easier to treat.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
From 50 to 74 YearsRange of ages for which participants are eligible to join.
Healthy volunteers allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Colorectal Cancer
Criteria

DISEASE CHARACTERISTICS: * Healthy participants * Eligible for colorectal cancer screening * No personal or family history of colorectal cancer * No more than 1 first-degree relative who has had colorectal cancer * Part 1: * Has not undergone regular screening for colorectal cancer * Part 2: * Not currently undergoing regular colon cancer testing, including any of the following: * Fecal occult blood testing within the past year * Flexible sigmoidoscopy or colonoscopy within the past 5 years PATIENT CHARACTERISTICS: Age * 50 to 74 Performance status * Not specified Life expectancy * Not specified Hematopoietic * Not specified Hepatic * Not specified Renal * Not specified Other * No inflammatory bowel disease (part 1 only) * No concurrent health issues that would preclude study participation (part 1 only) * No history of cancer except basal cell or squamous cell skin cancer (part 2 only) * Able to speak and read English (part 2 only) PRIOR CONCURRENT THERAPY: Biologic therapy * Not specified Chemotherapy * Not specified Endocrine therapy * Not specified Radiotherapy * Not specified Surgery * Not specified


Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Study Objectives
Study Objectives
Primary Objectives

Secondary Objectives


Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has 4 locations
Suspended
Warren Grant Magnuson Clinical Center - NCI Clinical Studies SupportBethesda, United StatesSee the location
Suspended
Kimmel Cancer Center at Thomas Jefferson University - PhiladelphiaPhiladelphia, United States
Suspended
Fox Chase Cancer CenterPhiladelphia, United States
Suspended
Vanderbilt-Ingram Cancer Center at Vanderbilt Medical CenterNashville, United States

Completed4 Study Centers