Colorectal Cancer
Conditions
Keywords
colon cancer, rectal cancer
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.
Interventions
BEHAVIORALNon-tailored CRC screening brochure
Patients receive written educational material about colorectal cancer and prompting to talk to their doctor about getting tested.
BEHAVIORALInteractive computer intervention
Sponsors
National Cancer Institute (NCI)
Indiana University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
51 Years to 80 Years
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| 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
| Measure | Time frame | Description |
|---|---|---|
| Self-reported CRC discussion and screening test recommendation from provider on intervention/clinic visit date | 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. |
| Provider documentation of CRC discussion and screening test recommendation on intervention/clinic visit date | 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. |
| Self-reported CRC health beliefs | 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. |
| Self-reported stage of CRC screening test adoption | 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
| Measure | Time frame | Description |
|---|---|---|
| Patient characteristics as CRC screening predictors | 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. |
| Clinic variables as CRC screening predictors | 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. |
Countries
United States
Outcome results
None listed