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- Klinische proef NCT00672828
Interactive Computer Program or Brochure in Increasing Colorectal Cancer Screening Among African Americans (PACT)
Promoting Colon 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.
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
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.
Studietype
Inschrijving (Werkelijk)
Fase
- Niet toepasbaar
Contacten en locaties
Studie Locaties
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Indiana
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Indianapolis, Indiana, Verenigde Staten, 46202
- Indiana University School of Nursing
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Preventie
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
---|---|
Actieve vergelijker: 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.
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Patients receive written educational material about colorectal cancer and prompting to talk to their doctor about getting tested.
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Experimenteel: 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.
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
---|---|
Self-reported colorectal cancer (CRC) screening adherence with medical record verification of screening test completion
Tijdsspanne: 6 and 15 months post-intervention
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6 and 15 months post-intervention
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
Self-reported CRC discussion and screening test recommendation from provider on intervention/clinic visit date
Tijdsspanne: 1 week post-intervention
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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.
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1 week post-intervention
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Provider documentation of CRC discussion and screening test recommendation on intervention/clinic visit date
Tijdsspanne: 1 week post-intervention
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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.
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1 week post-intervention
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Self-reported CRC health beliefs
Tijdsspanne: Pre-intervention (baseline),1 week post-intervention, and 6 months post-intervention
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Changes in perceived risk, benefits to screening, barriers to screening, and self-efficacy for CRC screening are assessed.
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Pre-intervention (baseline),1 week post-intervention, and 6 months post-intervention
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Self-reported stage of CRC screening test adoption
Tijdsspanne: Pre-intervention (baseline),1 week post-intervention, 6 months post-intervention, and 15 months post-intervention
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For FOBT, colonoscopy, and sigmoidoscopy, stage of adoption measured as either precontemplation, contemplation, preparation, action, or maintenance.
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Pre-intervention (baseline),1 week post-intervention, 6 months post-intervention, and 15 months post-intervention
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Andere uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Patient characteristics as CRC screening predictors
Tijdsspanne: Pre-intervention (baseline), intervention date, 1 week post-intervention, 6 months post-intervention, and/or 15 months post-intervention
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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.
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Pre-intervention (baseline), intervention date, 1 week post-intervention, 6 months post-intervention, and/or 15 months post-intervention
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Clinic variables as CRC screening predictors
Tijdsspanne: Pre-intervention (baseline), 1 week post-intervention, 6 months post-intervention, and 15 months post-intervention
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Clinic site, participant's reason for health care provider visit, and prior recommendation(s) to do CRC screening are assessed.
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Pre-intervention (baseline), 1 week post-intervention, 6 months post-intervention, and 15 months post-intervention
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Medewerkers en onderzoekers
Sponsor
Medewerkers
Onderzoekers
- Hoofdonderzoeker: Susan Rawl, PhD, RN, Indiana University School of Medicine
Publicaties en nuttige links
Algemene publicaties
- 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.
- 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.
Studie record data
Bestudeer belangrijke data
Studie start
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Schatting)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- IUSN-0604-01B
- CDR0000584262 (Register-ID: PDQ (Physician Data Query))
- 5R01CA115983-05 (Subsidie/contract van de Amerikaanse NIH)
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .
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