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

NCT ID: NCT00478309

Last Updated: 2016-03-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 697 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-03-31

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.

Conditions

Colorectal Cancer; Healthy, no Evidence of Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Arm I

Participants receive standard primary care.

Group Type: NO_INTERVENTION

No interventions assigned to this group

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.

Group Type: EXPERIMENTAL

counseling intervention

Intervention Type: OTHER

educational intervention

Intervention Type: OTHER

Interventions

counseling intervention

Intervention Type: OTHER

educational intervention

Intervention Type: OTHER

Eligibility Criteria

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)

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Fox Chase Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

David Weinberg, MD, MSC

Role: STUDY_CHAIR

Fox Chase Cancer Center

Locations

Fox Chase Cancer Center - Philadelphia

Philadelphia, Pennsylvania, United States

Countries

United States

References

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.

Reference Type: RESULT

PMID: 20828635 (View on PubMed)

Other Identifiers

IRB#06807

Identifier Type: OTHER

Identifier Source: secondary_id

CDR0000538405

Identifier Type: -

Identifier Source: org_study_id