Genetic and Environmental Risk Assessment for Colorectal Cancer in Healthy Participants

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Fox Chase Cancer Center
ClinicalTrials.gov Identifier:
NCT00087360
First received: July 8, 2004
Last updated: July 10, 2013
Last verified: July 2013

July 8, 2004
July 10, 2013
November 2003
May 2007   (final data collection date for primary outcome measure)
Colorectal cancer (CRC) screening rates by chart review at 4 months [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00087360 on ClinicalTrials.gov Archive Site
  • Knowledge regarding CRC risk by questionnaires at 4 and 12 months [ Designated as safety issue: No ]
  • CRC risk perception by questionnaires at 4 and 12 months [ Designated as safety issue: No ]
Not Provided
Not Provided
Not Provided
 
Genetic and Environmental Risk Assessment for Colorectal Cancer in Healthy Participants
Providing Genetic And Environmental Cancer Risk Assessment In Primary Care

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.

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.

Interventional
Not Provided
Primary Purpose: Screening
Colorectal Cancer
  • Other: counseling intervention
  • Other: physiologic testing
  • Procedure: evaluation of cancer risk factors
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
Not Provided
May 2007
May 2007   (final data collection date for primary outcome measure)

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
Both
50 Years to 74 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00087360
FCCC-03030, CDR0000374972
No
Fox Chase Cancer Center
Fox Chase Cancer Center
National Cancer Institute (NCI)
Study Chair: David Weinberg, MD, MSC Fox Chase Cancer Center
Fox Chase Cancer Center
July 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP