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

Fox Chase Cancer Center697 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

697

Conditions

Colorectal Cancer Healthy, no Evidence of Disease

Interventions

counseling interventionOTHER

educational interventionOTHER

Eligibility

Sex: ALLMin age: 50 YearsHealthy volunteers:

Medical Language ↔ Plain English

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)

Locations (1)

Fox Chase Cancer Center - Philadelphia

Philadelphia, Pennsylvania, United States

Outcomes

Primary Outcomes

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

Data from ClinicalTrials.gov

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