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

Colorectal Cancer Clinical Trial

— PACT  

Official title:

Promoting Colon Cancer Screening Among African Americans

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00672828
• Other study ID #: IUSN-0604-01B
• Secondary ID: CDR00005842625R0
• Status: Completed
• Phase: N/A
• First received: May 3, 2008
• Last updated: August 16, 2013
• Start date: January 2008
• Est. completion date: April 2012

Study information

• Verified date: August 2013
• Source: Indiana University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 693
• Est. completion date: April 2012
• Est. primary completion date: April 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 51 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Intervention

Behavioral:
• Non-tailored CRC screening brochure
Patients receive written educational material about colorectal cancer and prompting to talk to their doctor about getting tested.
• Interactive computer intervention

Locations

Country	Name	City	State
United States	Indiana University School of Nursing	Indianapolis	Indiana

Sponsors (2)

Lead Sponsor	Collaborator
Indiana University	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Patient characteristics as CRC screening predictors	Age, gender, marital status, education, health literacy, income, employment, insurance coverage, BMI, co-morbidities, family history of cancer, family or friend encouragement to have CRC screening, CRC knowledge, physician trust, fatalism views, and health temporal orientation are assessed.	Pre-intervention (baseline), intervention date, 1 week post-intervention, 6 months post-intervention, and/or 15 months post-intervention	No
Other	Clinic variables as CRC screening predictors	Clinic site, participant's reason for health care provider visit, and prior recommendation(s) to do CRC screening are assessed.	Pre-intervention (baseline), 1 week post-intervention, 6 months post-intervention, and 15 months post-intervention	No
Primary	Self-reported colorectal cancer (CRC) screening adherence with medical record verification of screening test completion		6 and 15 months post-intervention	No
Secondary	Self-reported CRC discussion and screening test recommendation from provider on intervention/clinic visit date	Discussion of Fecal Occult Blood Test (FOBT), colonoscopy, and sigmoidoscopy is assessed. Participants report on whether or not an FOBT kit was given to them during this visit. Additionally, participants report on whether or not someone in the doctor's office made an appointment for a colonoscopy or sigmoidoscopy.	1 week post-intervention	No
Secondary	Provider documentation of CRC discussion and screening test recommendation on intervention/clinic visit date	Medical record documentation of discussion of FOBT, providing participant with an FOBT kit, discussion and/or ordering a colonoscopy, and discussion and/or ordering a sigmoidoscopy is assessed.	1 week post-intervention	No
Secondary	Self-reported CRC health beliefs	Changes in perceived risk, benefits to screening, barriers to screening, and self-efficacy for CRC screening are assessed.	Pre-intervention (baseline),1 week post-intervention, and 6 months post-intervention	No
Secondary	Self-reported stage of CRC screening test adoption	For FOBT, colonoscopy, and sigmoidoscopy, stage of adoption measured as either precontemplation, contemplation, preparation, action, or maintenance.	Pre-intervention (baseline),1 week post-intervention, 6 months post-intervention, and 15 months post-intervention	No