Interactive Computer Program or Brochure in Increasing Colorectal Cancer Screening Among African Americans (PACT)
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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: Single Group Assignment Primary Purpose: Prevention |
| Official Title: | Promoting Colon Cancer Screening Among African Americans |
- 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 ]
- 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 FOBT, colonoscopy, and sigmoidoscopy is assessed. Particpants 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.
- 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 |
DISEASE CHARACTERISTICS:
- Currently being seen in the primary care clinics of either Wishard Memorial Hospital OR Roudebush Veterans Affairs Medical Center
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| United States, Indiana | |
| Indiana University School of Nursing | |
| Indianapolis, Indiana, United States, 46202 | |
| 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 |
| Study First Received: | May 3, 2008 |
| Last Updated: | March 21, 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 May 16, 2013