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Providing Genetic And Environmental Cancer Risk Assessment In Primary Care


N/A
50 Years
74 Years
Not Enrolling
Both
Colorectal Cancer

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Trial Information

Providing Genetic And Environmental Cancer Risk Assessment In Primary Care


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.

Inclusion Criteria


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

Type of Study:

Interventional

Study Design:

Primary Purpose: Screening

Outcome Measure:

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

Safety Issue:

No

Principal Investigator

David Weinberg, MD, MSC

Investigator Role:

Study Chair

Investigator Affiliation:

Fox Chase Cancer Center

Authority:

United States: Federal Government

Study ID:

CDR0000374972

NCT ID:

NCT00087360

Start Date:

November 2003

Completion Date:

Related Keywords:

  • Colorectal Cancer
  • colon cancer
  • rectal cancer
  • Colorectal Neoplasms

Name

Location

Fox Chase Cancer CenterPhiladelphia, Pennsylvania  19111
Kimmel Cancer Center at Thomas Jefferson University - PhiladelphiaPhiladelphia, Pennsylvania  19107
Vanderbilt-Ingram Cancer Center at Vanderbilt Medical CenterNashville, Tennessee  37232-2516
Warren Grant Magnuson Clinical Center - NCI Clinical Studies SupportBethesda, Maryland  20892-1182