- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg 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.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
-
-
Indiana
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Indianapolis, Indiana, Forenede Stater, 46202
- Indiana University School of Nursing
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-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Forebyggelse
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Aktiv komparator: 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.
|
Patients receive written educational material about colorectal cancer and prompting to talk to their doctor about getting tested.
|
Eksperimentel: 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.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
Self-reported colorectal cancer (CRC) screening adherence with medical record verification of screening test completion
Tidsramme: 6 and 15 months post-intervention
|
6 and 15 months post-intervention
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Self-reported CRC discussion and screening test recommendation from provider on intervention/clinic visit date
Tidsramme: 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.
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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
Tidsramme: 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.
|
1 week post-intervention
|
Self-reported CRC health beliefs
Tidsramme: 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
Tidsramme: 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.
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Pre-intervention (baseline),1 week post-intervention, 6 months post-intervention, and 15 months post-intervention
|
Andre resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Patient characteristics as CRC screening predictors
Tidsramme: 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
Tidsramme: 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
|
Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Susan Rawl, PhD, RN, Indiana University School of Medicine
Publikationer og nyttige links
Generelle publikationer
- 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.
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- IUSN-0604-01B
- CDR0000584262 (Registry Identifier: PDQ (Physician Data Query))
- 5R01CA115983-05 (U.S. NIH-bevilling/kontrakt)
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