Clinical trial NCT00087360: Genetic and Environmental Risk Assessment for Colorectal Cancer in Healthy Participants
Official title: Providing Genetic And Environmental Cancer Risk Assessment In Primary Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colorectal Cancer
Keywords: colon cancer
rectal cancer
Lead sponsor: Fox Chase Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2004-07-12
Sex: ALL
Minimum age (years): 50
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Primary purpose: SCREENING

Brief 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.

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.

Eligibility 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

Primary outcomes:
measure: Colorectal cancer (CRC) screening rates by chart review at 4 months
Secondary outcomes:
measure: Knowledge regarding CRC risk by questionnaires at 4 and 12 months
measure: CRC risk perception by questionnaires at 4 and 12 months
Other outcomes:
Locations:
city: Bethesda
country: United States
facility: Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support
state: Maryland
city: Philadelphia
country: United States
facility: Kimmel Cancer Center at Thomas Jefferson University - Philadelphia
state: Pennsylvania
city: Philadelphia
country: United States
facility: Fox Chase Cancer Center
state: Pennsylvania
city: Nashville
country: United States
facility: Vanderbilt-Ingram Cancer Center at Vanderbilt Medical Center
state: Tennessee
Study officials:
affiliation: Fox Chase Cancer Center
name: David Weinberg, MD, MSC
role: STUDY_CHAIR
References:
citation: 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.