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

Gene Environment Risk Assessment and CRC Screening

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00478309

Enrollment

697

Registered

2007-05-24

Start date

2007-03-31

Completion date

Unknown

Last updated

2016-03-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colorectal Cancer, Healthy, no Evidence of Disease

Keywords

colon cancer, rectal cancer, healthy, no evidence of disease

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.

Interventions

OTHERcounseling intervention

OTHEReducational intervention

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

50 Years to No maximum

Healthy volunteers

Yes

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)

Design outcomes

Primary

Measure	Time frame
Factors that moderate the impact of GERA feedback on CRC screening utilization	At study completion
Comparison of Genetic Epidemiology and Risk Assessment (GERA) feedback vs usual care (UC) in terms of colorectal cancer (CRC) screening utilization	At study completion
Impact of GERA feedback and UC on psychological distress	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	At study completion

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026