Genetic and Environmental Risk Assessment for Colorectal Cancer in Healthy Participants

Colorectal Cancer Clinical Trial

Official title:

Providing Genetic And Environmental Cancer Risk Assessment In Primary Care

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00087360
• Other study ID #: FCCC-03030
• Secondary ID: CDR0000374972
• Status: Completed
• Phase: N/A
• First received: July 8, 2004
• Last updated: July 10, 2013
• Start date: November 2003
• Est. completion date: May 2007

Study information

• Verified date: July 2013
• Source: Fox Chase Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: May 2007
• Est. primary completion date: May 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 50 Years to 74 Years

Eligibility

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

Study Design

Primary Purpose: Screening

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Intervention

Other:
• counseling intervention

• physiologic testing

Procedure:
• evaluation of cancer risk factors

Locations

Country	Name	City	State
United States	Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support	Bethesda	Maryland
United States	Vanderbilt-Ingram Cancer Center at Vanderbilt Medical Center	Nashville	Tennessee
United States	Fox Chase Cancer Center	Philadelphia	Pennsylvania
United States	Kimmel Cancer Center at Thomas Jefferson University - Philadelphia	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Fox Chase Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Colorectal cancer (CRC) screening rates by chart review at 4 months			No
Secondary	Knowledge regarding CRC risk by questionnaires at 4 and 12 months			No
Secondary	CRC risk perception by questionnaires at 4 and 12 months			No