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Completed

NCT Number: NCT00672828

Interactive Computer Program or Brochure in Increasing Colorectal 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.

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Key information

Conditions

Colorectal Cancer Colonic Diseases Colonic Neoplasms Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases Rectal Neoplasms

Age range

51 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Indiana University School of Nursing

Indianapolis, Indiana, 46202, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Non-tailored CRC screening brochure

Behavioral

Patients receive written educational material about colorectal cancer and prompting to talk to their doctor about getting tested.

Interactive computer intervention

Behavioral

Primary outcomes

  1. Self-reported colorectal cancer (CRC) screening adherence with medical record verification of screening test completion

    Time frame: 6 and 15 months post-intervention

Secondary outcomes

  1. Self-reported CRC discussion and screening test recommendation from provider on intervention/clinic visit date

    Time frame: 1 week post-intervention

    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.

  2. Provider documentation of CRC discussion and screening test recommendation on intervention/clinic visit date

    Time frame: 1 week post-intervention

    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.

  3. Self-reported CRC health beliefs

    Time frame: Pre-intervention (baseline),1 week post-intervention, and 6 months post-intervention

    Changes in perceived risk, benefits to screening, barriers to screening, and self-efficacy for CRC screening are assessed.

  4. 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

    For FOBT, colonoscopy, and sigmoidoscopy, stage of adoption measured as either precontemplation, contemplation, preparation, action, or maintenance.

Other outcomes

  1. 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

    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.

  2. Clinic variables as CRC screening predictors

    Time frame: Pre-intervention (baseline), 1 week post-intervention, 6 months post-intervention, and 15 months post-intervention

    Clinic site, participant's reason for health care provider visit, and prior recommendation(s) to do CRC screening are assessed.

Sponsors and collaborators

Lead sponsor

Indiana University

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

Promoting Colon Cancer Screening Among African Americans

Acronym: PACT

Important dates

Study start
2008
Primary completion
2012
Study completion
2012
First posted
May 6, 2008
Registry last updated
Aug 20, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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