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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2009 by National Cancer Institute (NCI).
Recruitment status was  Recruiting
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00478309
First received: May 23, 2007
Last updated: April 16, 2011
Last verified: June 2009
History of Changes

May 23, 2007
April 16, 2011
March 2007
March 2012   (final data collection date for primary outcome measure)
  • Comparison of Genetic Epidemiology and Risk Assessment (GERA) feedback vs usual care (UC) in terms of colorectal cancer (CRC) screening utilization [ Designated as safety issue: No ]
  • Impact of GERA feedback and UC on psychological distress [ Designated as safety issue: No ]
  • 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 [ Designated as safety issue: No ]
  • Factors that moderate the impact of GERA feedback on CRC screening utilization [ Designated as safety issue: No ]
  • 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
Complete list of historical versions of study NCT00478309 on ClinicalTrials.gov Archive Site
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Genetic Epidemiology Risk Assessment Program or Usual Care in Colorectal Cancer Screening for Healthy Participants
Gene Environment Risk Assessment and CRC Screening

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.

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.
Interventional
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Allocation: Randomized
Primary Purpose: Health Services Research
  • Colorectal Cancer
  • Healthy, no Evidence of Disease
  • Other: counseling intervention
  • Other: educational intervention
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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. Epub 2010 Sep 7.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
1950
Not Provided
March 2012   (final data collection date for primary outcome measure)

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)
Both
50 Years and older
Yes
Not Provided
United States
 
NCT00478309
CDR0000538405, FCCC-06807, FCCC-IRB-06-807
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Fox Chase Cancer Center
National Cancer Institute (NCI)
Study Chair: David Weinberg, MD, MSC Fox Chase Cancer Center
National Cancer Institute (NCI)
June 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP