NCT00478309

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

Gene Environment Risk Assessment and CRC Screening

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 697 (actual)
• Sponsor: Fox Chase Cancer Center · Academic / Other
• Sex: All
• Age: 50 Years
• Healthy volunteers: Accepted

Summary

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

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.

Conditions

• Colorectal Cancer
• Healthy, no Evidence of Disease

Interventions

Type	Name	Description
OTHER	counseling intervention
OTHER	educational intervention

Timeline

• Start date: 2007-03-01
• Primary completion: 2014-03-01
• First posted: 2007-05-24
• Last updated: 2016-03-03

Locations

1 site across 1 country: United States