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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Fox Chase Cancer Center
ClinicalTrials.gov Identifier:
NCT00478309
First received: May 23, 2007
Last updated: July 9, 2013
Last verified: July 2013
  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
Primary Purpose: Health Services Research
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 [ 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 ]

Estimated Enrollment: 1950
Study Start Date: March 2007
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
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

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

Additional Information:
Publications:
Responsible Party: Fox Chase Cancer Center
ClinicalTrials.gov Identifier: NCT00478309     History of Changes
Other Study ID Numbers: CDR0000538405, IRB#06807
Study First Received: May 23, 2007
Last Updated: July 9, 2013
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on October 01, 2014