Interactive Computer Program or Brochure in Increasing Colorectal Cancer Screening Among African Americans (PACT)

Indiana University

Status: Completed

Conditions: Colorectal Cancer

Treatments: Behavioral: Interactive computer intervention; Behavioral: Non-tailored CRC screening brochure

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00672828

IUSN-0604-01B

CDR0000584262 (Registry Identifier)

5R01CA115983-05 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

RATIONALE: An interactive computer program may be more effective than a brochure in increasing colorectal cancer screening among African Americans.

PURPOSE: This randomized clinical trial is studying an interactive computer program to see how well it works compared with a brochure in increasing colorectal cancer screening among African Americans.

Full description

OBJECTIVES:

• Compare rates of participation in fecal occult blood testing and endoscopic screening (colonoscopy or sigmoidoscopy) among African-Americans who receive an interactive computer intervention (ICI) versus a non-tailored colorectal cancer screening brochure.
• Examine mediators and moderators of intervention effectiveness as depicted in the conceptual model.

OUTLINE: This is a multicenter study.

Participants are stratified according to site, age (≤ 65 years old vs > 65 years old) and gender. Participants are randomized to one of two arms.

• Arm I (non-tailored colorectal cancer screening brochure): Participants undergo a baseline interview via telephone and receive a colorectal cancer screening brochure in the clinic prior to visit with healthcare provider. Participants then undergo telephone interviews at 1 week, 6 months, and 15 months.
• Arm II (interactive computer intervention [ICI]): Participants undergo a baseline interview via telephone and complete an ICI in the clinic prior to visit with healthcare provider. Participants then undergo telephone interviews at 1 week, 6 months, and 15 months.

Enrollment: 693 patients

Sex: All

Ages: 51 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

DISEASE CHARACTERISTICS:

• Currently being seen in the primary care clinics of Wishard Memorial Hospital (Indianapolis, IN), Roudebush Veterans Affairs Medical Center (Indianapolis, IN), IU Health Family Medicine Center (Indianapolis, IN) or Norton Louisville Primary Care Clinic (Louisville, KY)

• African-American who is currently non-adherent to screening guidelines, meeting all of the following criteria:

  • No fecal occult blood test in the past 12 months
  • No sigmoidoscopy in the past 5 years
  • No colonoscopy in the past 10 years

• Patients with average and increased risk for colorectal cancer are eligible

• No personal history of colorectal cancer

PATIENT CHARACTERISTICS:

• Participants must have a telephone
• English-speaking
• Able to read at a 5th grade reading level
• No medical condition that prohibits colorectal cancer screening

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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693 participants in 2 patient groups

Non-tailored CRC screening brochure

Active Comparator group

Description:

Participants undergo a baseline interview via telephone and receive a non-tailored CRC screening brochure in the clinic prior to visit with healthcare provider. Participants then undergo telephone interviews at 1 week, 6 months, and 15 months.

Treatment:

Behavioral: Non-tailored CRC screening brochure

Interactive computer intervention

Experimental group

Description:

Participants undergo a baseline interview via telephone and complete an interactive computer intervention in the clinic prior to visit with healthcare provider. Participants then undergo telephone interviews at 1 week, 6 months, and 15 months.

Treatment:

Behavioral: Interactive computer intervention