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Gene Environment Risk Assessment and CRC Screening


N/A
50 Years
N/A
Open (Enrolling)
Both
Colorectal Cancer, Healthy, no Evidence of Disease

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Trial Information

Gene Environment Risk Assessment and CRC Screening


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.

Inclusion Criteria


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)

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Primary Purpose: Health Services Research

Outcome Measure:

Comparison of Genetic Epidemiology and Risk Assessment (GERA) feedback vs usual care (UC) in terms of colorectal cancer (CRC) screening utilization

Safety Issue:

No

Principal Investigator

David Weinberg, MD, MSC

Investigator Role:

Study Chair

Investigator Affiliation:

Fox Chase Cancer Center

Authority:

Unspecified

Study ID:

CDR0000538405

NCT ID:

NCT00478309

Start Date:

March 2007

Completion Date:

Related Keywords:

  • Colorectal Cancer
  • Healthy, no Evidence of Disease
  • colon cancer
  • rectal cancer
  • healthy, no evidence of disease
  • Colorectal Neoplasms

Name

Location
Fox Chase Cancer Center - Philadelphia Philadelphia, Pennsylvania  19111-2497