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| ID | Type | Description | Link |
|---|---|---|---|
| CDR0000584262 | Registry Identifier | PDQ (Physician Data Query) | |
| 5R01CA115983-05 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
OBJECTIVES:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Non-tailored CRC screening brochure | Active Comparator | 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. |
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| Interactive computer intervention | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Non-tailored CRC screening brochure | Behavioral | Patients receive written educational material about colorectal cancer and prompting to talk to their doctor about getting tested. |
| Measure | Description | Time Frame |
|---|---|---|
| Self-reported colorectal cancer (CRC) screening adherence with medical record verification of screening test completion | 6 and 15 months post-intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Self-reported CRC discussion and screening test recommendation from provider on intervention/clinic visit date | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Patient characteristics as CRC screening predictors | 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. | Pre-intervention (baseline), intervention date, 1 week post-intervention, 6 months post-intervention, and/or 15 months post-intervention |
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:
Patients with average and increased risk for colorectal cancer are eligible
No personal history of colorectal cancer
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
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| Name | Affiliation | Role |
|---|---|---|
| Susan Rawl, PhD, RN | Indiana University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Indiana University School of Nursing | Indianapolis | Indiana | 46202 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33549682 | Derived | 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. | |
| 23498096 | Derived | 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. |
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| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D003110 | Colonic Neoplasms |
| D012004 | Rectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
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| Interactive computer intervention | Behavioral |
|
| 1 week post-intervention |
| Provider documentation of CRC discussion and screening test recommendation on intervention/clinic visit date | 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. | 1 week post-intervention |
| Self-reported CRC health beliefs | Changes in perceived risk, benefits to screening, barriers to screening, and self-efficacy for CRC screening are assessed. | Pre-intervention (baseline),1 week post-intervention, and 6 months post-intervention |
| Self-reported stage of CRC screening test adoption | For FOBT, colonoscopy, and sigmoidoscopy, stage of adoption measured as either precontemplation, contemplation, preparation, action, or maintenance. | Pre-intervention (baseline),1 week post-intervention, 6 months post-intervention, and 15 months post-intervention |
| Clinic variables as CRC screening predictors | Clinic site, participant's reason for health care provider visit, and prior recommendation(s) to do CRC screening are assessed. | Pre-intervention (baseline), 1 week post-intervention, 6 months post-intervention, and 15 months post-intervention |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |