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

Promoting Colon Cancer Screening Among African Americans

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.

Study Overview

• Status: Completed
• Conditions: Colorectal Cancer
• Intervention / Treatment: Behavioral: Non-tailored CRC screening brochure; Behavioral: Interactive computer intervention

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 693
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • Indiana University School of Nursing

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 51 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Non-tailored CRC screening brochure; 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.	Behavioral: Non-tailored CRC screening brochure; Patients receive written educational material about colorectal cancer and prompting to talk to their doctor about getting tested.
Experimental: Interactive computer intervention; 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.	Behavioral: Interactive computer intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Self-reported colorectal cancer (CRC) screening adherence with medical record verification of screening test completion	6 and 15 months post-intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Indiana University
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Susan Rawl, PhD, RN, Indiana University School of Medicine

Publications and helpful links

General Publications

• Rawl SM, Christy SM, Perkins SM, Tong Y, Krier C, Wang HL, Huang AM, Laury E, Rhyant B, Lloyd F, Willis DR, Imperiale TF, Myers LJ, Springston J, Skinner CS, Champion VL. Computer-tailored intervention increases colorectal cancer screening among low-income African Americans in primary care: Results of a randomized trial. Prev Med. 2021 Apr;145:106449. doi: 10.1016/j.ypmed.2021.106449. Epub 2021 Feb 4.
• Christy SM, Perkins SM, Tong Y, Krier C, Champion VL, Skinner CS, Springston JK, Imperiale TF, Rawl SM. Promoting colorectal cancer screening discussion: a randomized controlled trial. Am J Prev Med. 2013 Apr;44(4):325-329. doi: 10.1016/j.amepre.2012.11.032.

Study record dates

Study Major Dates

• Study Start: January 1, 2008
• Primary Completion (Actual): April 1, 2012
• Study Completion (Actual): April 1, 2012

Study Registration Dates

• First Submitted: May 3, 2008
• First Submitted That Met QC Criteria: May 3, 2008
• First Posted (Estimate): May 6, 2008

Study Record Updates

• Last Update Posted (Estimate): August 20, 2013
• Last Update Submitted That Met QC Criteria: August 16, 2013
• Last Verified: August 1, 2013

More Information

Terms related to this study

• Keywords: rectal cancer; colon cancer
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms
• Other Study ID Numbers: IUSN-0604-01B; CDR0000584262 (Registry Identifier: PDQ (Physician Data Query)); 5R01CA115983-05 (U.S. NIH Grant/Contract)