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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Indiana University
ClinicalTrials.gov Identifier:
NCT00672828
First received: May 3, 2008
Last updated: August 16, 2013
Last verified: August 2013
  Purpose

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.


Condition Intervention
Colorectal Cancer
Behavioral: Non-tailored CRC screening brochure
Behavioral: Interactive computer intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Promoting Colon Cancer Screening Among African Americans

Resource links provided by NLM:


Further study details as provided by Indiana University:

Primary Outcome Measures:
  • Self-reported colorectal cancer (CRC) screening adherence with medical record verification of screening test completion [ Time Frame: 6 and 15 months post-intervention ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Self-reported CRC discussion and screening test recommendation from provider on intervention/clinic visit date [ Time Frame: 1 week post-intervention ] [ Designated as safety issue: No ]
    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.

  • Provider documentation of CRC discussion and screening test recommendation on intervention/clinic visit date [ Time Frame: 1 week post-intervention ] [ Designated as safety issue: No ]
    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.

  • Self-reported CRC health beliefs [ Time Frame: Pre-intervention (baseline),1 week post-intervention, and 6 months post-intervention ] [ Designated as safety issue: No ]
    Changes in perceived risk, benefits to screening, barriers to screening, and self-efficacy for CRC screening are assessed.

  • Self-reported stage of CRC screening test adoption [ Time Frame: Pre-intervention (baseline),1 week post-intervention, 6 months post-intervention, and 15 months post-intervention ] [ Designated as safety issue: No ]
    For FOBT, colonoscopy, and sigmoidoscopy, stage of adoption measured as either precontemplation, contemplation, preparation, action, or maintenance.


Other Outcome Measures:
  • Patient characteristics as CRC screening predictors [ Time Frame: Pre-intervention (baseline), intervention date, 1 week post-intervention, 6 months post-intervention, and/or 15 months post-intervention ] [ Designated as safety issue: No ]
    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.

  • Clinic variables as CRC screening predictors [ Time Frame: Pre-intervention (baseline), 1 week post-intervention, 6 months post-intervention, and 15 months post-intervention ] [ Designated as safety issue: No ]
    Clinic site, participant's reason for health care provider visit, and prior recommendation(s) to do CRC screening are assessed.


Enrollment: 693
Study Start Date: January 2008
Study Completion Date: April 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.
  Eligibility

Ages Eligible for Study:   51 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00672828

Locations
United States, Indiana
Indiana University School of Nursing
Indianapolis, Indiana, United States, 46202
Sponsors and Collaborators
Indiana University
Investigators
Principal Investigator: Susan Rawl, PhD, RN Indiana University School of Medicine
  More Information

Additional Information:
No publications provided by Indiana University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Indiana University
ClinicalTrials.gov Identifier: NCT00672828     History of Changes
Other Study ID Numbers: IUSN-0604-01B, CDR0000584262, 5R01CA115983-05
Study First Received: May 3, 2008
Last Updated: August 16, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Indiana University:
colon cancer
rectal cancer

Additional relevant MeSH terms:
Colonic Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases

ClinicalTrials.gov processed this record on August 20, 2014