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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00478309
First Posted: May 24, 2007
Last Update Posted: March 3, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Fox Chase Cancer Center
  Purpose

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.


Condition Intervention
Colorectal Cancer Healthy, no Evidence of Disease Other: counseling intervention Other: educational intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Gene Environment Risk Assessment and CRC Screening

Resource links provided by NLM:


Further study details as provided by Fox Chase Cancer Center:

Primary Outcome Measures:
  • 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 ]
  • Impact of GERA feedback and UC on psychological distress [ Time Frame: At study completion ]
  • 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 ]
  • Factors that moderate the impact of GERA feedback on CRC screening utilization [ Time Frame: At study completion ]

Enrollment: 697
Study Start Date: March 2007
Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Arm I
Participants receive standard primary care.
Experimental: 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.
Other: counseling intervention Other: educational intervention

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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)
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00478309


Locations
United States, Pennsylvania
Fox Chase Cancer Center - Philadelphia
Philadelphia, Pennsylvania, United States, 19111-2497
Sponsors and Collaborators
Fox Chase Cancer Center
Investigators
Study Chair: David Weinberg, MD, MSC Fox Chase Cancer Center
  More Information

Publications:
Responsible Party: Fox Chase Cancer Center
ClinicalTrials.gov Identifier: NCT00478309     History of Changes
Other Study ID Numbers: CDR0000538405
IRB#06807 ( Other Identifier: Fox Chase Cancer Center )
First Submitted: May 23, 2007
First Posted: May 24, 2007
Last Update Posted: March 3, 2016
Last Verified: March 2016

Keywords provided by Fox Chase Cancer Center:
colon cancer
rectal cancer
healthy, no evidence of disease

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