Genetic and Environmental Risk Assessment for Colorectal Cancer in Healthy Participants

Study Overview
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Brief Summary
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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
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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 Title
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Providing Genetic And Environmental Cancer Risk Assessment In Primary Care

Conditions
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Colorectal Cancer

Intervention / Treatment
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* Other: counseling intervention
* Other: physiologic testing
* Procedure: evaluation of cancer risk factors


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 74 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening


Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: counseling intervention|nan|
|Other: physiologic testing|nan|
|Procedure: evaluation of cancer risk factors|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Colorectal cancer (CRC) screening rates by chart review at 4 months |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Knowledge regarding CRC risk by questionnaires at 4 and 12 months |  |  | 
| CRC risk perception by questionnaires at 4 and 12 months |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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colon cancer, rectal cancer