Genetic Epidemiology Risk Assessment Program or Usual Care in Colorectal Cancer Screening for Healthy Participants

Colorectal Cancer Clinical Trial

Official title:

Gene Environment Risk Assessment and CRC Screening

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00478309
• Other study ID #: CDR0000538405
• Secondary ID: IRB#06807
• Status: Completed
• Phase: N/A
• First received: May 23, 2007
• Last updated: March 1, 2016
• Start date: March 2007

Study information

• Verified date: March 2016
• Source: Fox Chase Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 697
• Est. primary completion date: March 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 50 Years and older

Eligibility

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)

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms
• Healthy, no Evidence of Disease

Intervention

Other:
• counseling intervention

• educational intervention

Locations

Country	Name	City	State
United States	Fox Chase Cancer Center - Philadelphia	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Fox Chase Cancer Center

Country where clinical trial is conducted

United States, 

References & Publications (1)

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comparison of Genetic Epidemiology and Risk Assessment (GERA) feedback vs usual care (UC) in terms of colorectal cancer (CRC) screening utilization		At study completion	No
Primary	Impact of GERA feedback and UC on psychological distress		At study completion	No
Primary	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		At study completion	No
Primary	Factors that moderate the impact of GERA feedback on CRC screening utilization		At study completion	No