Genetic Epidemiology Risk Assessment Program or Usual Care in Colorectal Cancer Screening for Healthy Participants
Primary Purpose
Colorectal Cancer, Healthy, no Evidence of Disease
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
counseling intervention
educational intervention
Sponsored by
About this trial
This is an interventional prevention trial for Colorectal Cancer focused on measuring colon cancer, rectal cancer, healthy, no evidence of disease
Eligibility 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)
Sites / Locations
- Fox Chase Cancer Center - Philadelphia
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Arm I
Arm II
Arm Description
Participants receive standard primary care.
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.
Outcomes
Primary Outcome Measures
Comparison of Genetic Epidemiology and Risk Assessment (GERA) feedback vs usual care (UC) in terms of colorectal cancer (CRC) screening utilization
Impact of GERA feedback and UC on psychological distress
Comparison of 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
Factors that moderate the impact of GERA feedback on CRC screening utilization
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00478309
Brief Title
Genetic Epidemiology Risk Assessment Program or Usual Care in Colorectal Cancer Screening for Healthy Participants
Official Title
Gene Environment Risk Assessment and CRC Screening
Study Type
Interventional
2. Study Status
Record Verification Date
March 2016
Overall Recruitment Status
Completed
Study Start Date
March 2007 (undefined)
Primary Completion Date
March 2014 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fox Chase Cancer Center
4. Oversight
5. Study Description
Brief Summary
RATIONALE: The Genetic Epidemiology and Risk Assessment program may be more effective than usual care in increasing the number of healthy participants who regularly receive screening for colorectal cancer.
PURPOSE: This randomized clinical trial is studying the Genetic Epidemiology and Risk Assessment program to see how well it works compared with usual care to increase colorectal cancer screening in healthy participants.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer, Healthy, no Evidence of Disease
Keywords
colon cancer, rectal cancer, healthy, no evidence of disease
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
697 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Arm I
Arm Type
No Intervention
Arm Description
Participants receive standard primary care.
Arm Title
Arm II
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
counseling intervention
Intervention Type
Other
Intervention Name(s)
educational intervention
Primary Outcome Measure Information:
Title
Comparison of Genetic Epidemiology and Risk Assessment (GERA) feedback vs usual care (UC) in terms of colorectal cancer (CRC) screening utilization
Time Frame
At study completion
Title
Impact of GERA feedback and UC on psychological distress
Time Frame
At study completion
Title
Comparison of 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
Time Frame
At study completion
Title
Factors that moderate the impact of GERA feedback on CRC screening utilization
Time Frame
At study completion
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Weinberg, MD, MSC
Organizational Affiliation
Fox Chase Cancer Center
Official's Role
Study Chair
Facility Information:
Facility Name
Fox Chase Cancer Center - Philadelphia
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19111-2497
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
20828635
Citation
Myers RE, Manne SL, Wilfond B, Sifri R, Ziring B, Wolf TA, Cocroft J, Ueland A, Petrich A, Swan H, DiCarlo M, Weinberg DS. A randomized trial of genetic and environmental risk assessment (GERA) for colorectal cancer risk in primary care: trial design and baseline findings. Contemp Clin Trials. 2011 Jan;32(1):25-31. doi: 10.1016/j.cct.2010.08.013. Epub 2010 Sep 7.
Results Reference
result
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Genetic Epidemiology Risk Assessment Program or Usual Care in Colorectal Cancer Screening for Healthy Participants
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