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.

Study Overview

• Status: Completed
• Conditions: Colorectal Cancer
• Intervention / Treatment: Other: physiologic testing; Procedure: evaluation of cancer risk factors; Other: counseling intervention

Detailed 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.

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Bethesda, Maryland, United States, 20892-1182
      • Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19111
      • Fox Chase Cancer Center
    • Philadelphia, Pennsylvania, United States, 19107-5541
      • Kimmel Cancer Center at Thomas Jefferson University - Philadelphia
  • Tennessee
    • Nashville, Tennessee, United States, 37232-0165
      • Vanderbilt-Ingram Cancer Center at Vanderbilt Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 74 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Screening

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Colorectal cancer (CRC) screening rates by chart review at 4 months

Secondary Outcome Measures

Outcome Measure
Knowledge regarding CRC risk by questionnaires at 4 and 12 months
CRC risk perception by questionnaires at 4 and 12 months

Collaborators and Investigators

• Sponsor: Fox Chase Cancer Center
• Collaborators: National Cancer Institute (NCI)
• Investigators: Study Chair: David Weinberg, MD, MSC, Fox Chase Cancer Center

Publications and helpful links

General Publications

• Weinberg DS, Myers RE, Keenan E, Ruth K, Sifri R, Ziring B, Ross E, Manne SL. Genetic and environmental risk assessment and colorectal cancer screening in an average-risk population: a randomized trial. Ann Intern Med. 2014 Oct 21;161(8):537-45. doi: 10.7326/M14-0765.

Study record dates

Study Major Dates

• Study Start: November 1, 2003
• Primary Completion (Actual): May 1, 2007
• Study Completion (Actual): May 1, 2007

Study Registration Dates

• First Submitted: July 8, 2004
• First Submitted That Met QC Criteria: July 9, 2004
• First Posted (Estimate): July 12, 2004

Study Record Updates

• Last Update Posted (Estimate): July 11, 2013
• Last Update Submitted That Met QC Criteria: July 10, 2013
• Last Verified: July 1, 2013

More Information

Terms related to this study

• Keywords: rectal cancer; colon cancer
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms
• Other Study ID Numbers: FCCC-03030; CDR0000374972 (Registry Identifier: PDQ (Physician Data Query))