Genetic Epidemiology Risk Assessment Program or Usual Care in Colorectal Cancer Screening for Healthy Participants

Study Overview
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Brief Summary
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RATIONALE: The Genetic Epidemiology and Risk Assessment program may be more effective than usual care in increasing the number of healthy participants who regularly receive screening for colorectal cancer. PURPOSE: This randomized clinical trial is studying the Genetic Epidemiology and Risk Assessment program to see how well it works compared with usual care to increase colorectal cancer screening in healthy participants.

Detailed Description
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OBJECTIVES: Compare Genetic Epidemiology and Risk Assessment (GERA) feedback vs usual care (UC) in terms of colorectal cancer (CRC) screening utilization by healthy participants. Determine the impact of GERA feedback and UC on psychological distress in these participants. Compare GERA feedback vs UC in terms of intention to have CRC screening, perceived CRC risk, CRC knowledge, salience and coherence of CRC screening, and support for CRC screening in these participants. Identify factors that moderate the impact of GERA feedback on CRC screening utilization. OUTLINE: This is a randomized study. Participants are randomized to 1 of 2 screening arms. Arm I: Participants receive standard primary care. Arm II: Participants receive standard primary care followed by the Genetic Epidemiology and Risk Assessment (GERA) intervention. Participants also participate in a discussion session regarding the GERA including the rationale behind methylenetetrahydrofolate reductase mutation detection and folate assessment and its relationship to colorectal cancer risk. All participants undergo a fecal occult blood test 3 weeks after the screening office visit. PROJECTED ACCRUAL: A total of 1,950 participants will be accrued for this study.

Official Title
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Gene Environment Risk Assessment and CRC Screening

Conditions
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Colorectal Cancer, Healthy, no Evidence of Disease

Intervention / Treatment
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* Other: counseling intervention
* Other: educational intervention


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Healthy participants meeting the following criteria: No personal history of colorectal polyps or cancer or inflammatory bowel disease No family history of familial adenomatous polyposis, hereditary nonpolyposis colorectal cancer (CRC), or CRC in more than 1 first-degree relative Nonadherent with standard CRC screening recommendations at the time of their index office visit PATIENT CHARACTERISTICS: Able to communicate with ease in English PRIOR CONCURRENT THERAPY: More than 6 weeks since prior antibiotics or antifolate medications (e.g., sulfasalazine, methotrexate)

Ages Eligible for Study
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Minimum Age: 50 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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Arm I<br>Participants receive standard primary care. | |
| Experimental: Arm II<br>Participants receive standard primary care followed by the Genetic Epidemiology and Risk Assessment (GERA) intervention. Participants also participate in a discussion session regarding the GERA including the rationale behind methylenetetrahydrofolate reductase mutation detection and folate assessment and its relationship to colorectal cancer risk. | Other: counseling intervention<br> <br> Other: educational intervention<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of Genetic Epidemiology and Risk Assessment (GERA) feedback vs usual care (UC) in terms of colorectal cancer (CRC) screening utilization |  | At study completion | 
| Impact of GERA feedback and UC on psychological distress |  | At study completion | 
| Comparison of GERA feedback vs UC in terms of intention to have CRC screening, perceived CRC risk, CRC knowledge, salience and coherence of CRC screening, and support for CRC screening |  | At study completion | 
| Factors that moderate the impact of GERA feedback on CRC screening utilization |  | At study completion | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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colon cancer, rectal cancer, healthy, no evidence of disease