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

Temple University Health System (TUHS)

Status: Completed

Conditions: Healthy, no Evidence of Disease; Colorectal Cancer

Treatments: Other: counseling intervention; Other: educational intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT00478309

IRB#06807 (Other Identifier)

CDR0000538405

Details and patient eligibility

About

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.

Full 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.

Enrollment: 697 patients

Sex: All

Ages: 50+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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)

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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697 participants in 2 patient groups

Arm I

No Intervention group

Description:

Participants receive standard primary care.

Arm II

Experimental group

Description:

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.

Treatment:

Other: educational intervention

Other: counseling intervention