Genetic and Environmental Risk Assessment for Colorectal Cancer in Healthy Participants
This study has been completed.
Sponsor:
Fox Chase Cancer Center
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00087360
First received: July 8, 2004
Last updated: March 7, 2009
Last verified: August 2005
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Colorectal Cancer |
Other: counseling intervention Other: physiologic testing Procedure: evaluation of cancer risk factors |
| Study Type: | Interventional |
| Study Design: | Primary Purpose: Screening |
| Official Title: | Providing Genetic And Environmental Cancer Risk Assessment In Primary Care |
Resource links provided by NLM:
Further study details as provided by National Cancer Institute (NCI):
Primary Outcome Measures:
- Colorectal cancer (CRC) screening rates by chart review at 4 months [ Designated as safety issue: No ]
Secondary Outcome Measures:
- 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 ]
| Study Start Date: | November 2003 |
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| Ages Eligible for Study: | 50 Years to 74 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00087360
Locations
| United States, Maryland | |
| Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support | |
| Bethesda, Maryland, United States, 20892-1182 | |
| United States, Pennsylvania | |
| Fox Chase Cancer Center | |
| Philadelphia, Pennsylvania, United States, 19111 | |
| Kimmel Cancer Center at Thomas Jefferson University - Philadelphia | |
| Philadelphia, Pennsylvania, United States, 19107-5541 | |
| United States, Tennessee | |
| Vanderbilt-Ingram Cancer Center at Vanderbilt Medical Center | |
| Nashville, Tennessee, United States, 37232-0165 | |
Sponsors and Collaborators
Fox Chase Cancer Center
Investigators
| Study Chair: | David Weinberg, MD, MSC | Fox Chase Cancer Center |
More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00087360 History of Changes |
| Other Study ID Numbers: | CDR0000374972, FCCC-03030 |
| Study First Received: | July 8, 2004 |
| Last Updated: | March 7, 2009 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Cancer Institute (NCI):
|
colon cancer rectal cancer |
Additional relevant MeSH terms:
|
Colorectal Neoplasms Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms |
Digestive System Diseases Gastrointestinal Diseases Colonic Diseases Intestinal Diseases Rectal Diseases |
ClinicalTrials.gov processed this record on May 23, 2013