Overview

This trial is active, not recruiting.

Conditions colorectal cancer, healthy, no evidence of disease
Treatments counseling intervention, educational intervention
Sponsor Fox Chase Cancer Center
Start date March 2007
End date March 2014
Trial size 1950 participants
Trial identifier NCT00478309, CDR0000538405, IRB#06807

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Primary purpose health services research

Primary Outcomes

Measure
Comparison of Genetic Epidemiology and Risk Assessment (GERA) feedback vs usual care (UC) in terms of colorectal cancer (CRC) screening utilization
time frame:
Impact of GERA feedback and UC on psychological distress
time frame:
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
time frame:
Factors that moderate the impact of GERA feedback on CRC screening utilization
time frame:

Eligibility Criteria

Male or female participants at least 50 years old.

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)

Additional Information

Official title Gene Environment Risk Assessment and CRC Screening
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.
Trial information was received from ClinicalTrials.gov and was last updated in July 2013.
Information provided to ClinicalTrials.gov by Fox Chase Cancer Center.