Clinical trial NCT00672828: Interactive Computer Program or Brochure in Increasing Colorectal Cancer Screening Among African Americans
Official title: Promoting Colon Cancer Screening Among African Americans
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colorectal Cancer
Keywords: colon cancer
rectal cancer
Lead sponsor: Indiana University
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2008-05-06
Enrollment: 693
Sex: ALL
Minimum age (years): 51
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

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 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

Primary outcomes:
measure: Self-reported colorectal cancer (CRC) screening adherence with medical record verification of screening test completion
timeFrame: 6 and 15 months post-intervention
Secondary outcomes:
measure: Self-reported CRC discussion and screening test recommendation from provider on intervention/clinic visit date
timeFrame: 1 week post-intervention
measure: Provider documentation of CRC discussion and screening test recommendation on intervention/clinic visit date
timeFrame: 1 week post-intervention
measure: Self-reported CRC health beliefs
timeFrame: Pre-intervention (baseline),1 week post-intervention, and 6 months post-intervention
measure: Self-reported stage of CRC screening test adoption
timeFrame: Pre-intervention (baseline),1 week post-intervention, 6 months post-intervention, and 15 months post-intervention
Other outcomes:
measure: Patient characteristics as CRC screening predictors
timeFrame: Pre-intervention (baseline), intervention date, 1 week post-intervention, 6 months post-intervention, and/or 15 months post-intervention
measure: Clinic variables as CRC screening predictors
timeFrame: Pre-intervention (baseline), 1 week post-intervention, 6 months post-intervention, and 15 months post-intervention
Locations:
city: Indianapolis
country: United States
facility: Indiana University School of Nursing
state: Indiana
Study officials:
affiliation: Indiana University School of Medicine
name: Susan Rawl, PhD, RN
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.