Colorectal Cancer Clinical Trial
Official title:
Gene Environment Risk Assessment and CRC Screening
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.
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.
;
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
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