Øget screening af kolorektal og brystkræft hos kvinder (COBRA)
8. september 2017 opdateret af: Victoria L. Champion, Indiana University
Denne undersøgelse sammenligner effektiviteten (adhærens og stadie) af fire interventioner til fremme af kolorektal (CRC) og brystkræft (BC) screeninger blandt kvinder i alderen 50 til 75. De er:
- sædvanlig pleje;
- et TIWeb (skræddersyet interventionswebsted)
- et CSC (cancer screening call) og
- TIWeb + en CSC. Denne undersøgelse sammenligner også omkostningseffektiviteten af de 4 interventioner til fremme af CRC- og BC-screening blandt kvinder i alderen 50 til 75.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Denne undersøgelse omhandler innovative tilgange til at øge overholdelse af screeningstests for tyktarms- og brystkræft - to kræftformer, der har den største indvirkning på kvindelig kræftdødelighed i USA. Kræftbyrden hos kvinder kan reduceres betydeligt ved at øge deltagelsen i anbefalet screening for kolorektal screening kræft (CRC) og brystkræft (BC) hos alle berettigede kvinder.
Denne forskning tester intervention for samtidig at øge både CRC- og BC-screening ved hjælp af adfærdsændringsstrategier og estimerer også effektiviteten og omkostningseffektiviteten af interventionerne.
To grupper af kvinder, gruppe A (overholder retningslinjer for BC-screening, men IKKE CRC-screening-retningslinjer) og gruppe B (ikke-overholder BC & CRC-retningslinjer) er randomiseret til 1. Usual Care, 2. TIWeb, 3. CSC og 4. TIWeb +CSC.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
1196
Fase
- Ikke anvendelig
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
50 år til 75 år (VOKSEN, OLDER_ADULT)
Tager imod sunde frivillige
Ja
Køn, der er berettiget til at studere
Kvinde
Beskrivelse
Inklusionskriterier:
- en patient af nogen af de deltagende læger
- ikke at have taget en fækal okkult blodprøve (fobt) inden for de sidste 12 måneder
- ikke har haft en fækal immunokemisk test (tilpasning) inden for de seneste 15 måneder
- ikke have haft sigmoidoskopi for mere end 5 år siden
- ikke have fået foretaget en koloskopi for mere end 10 år siden
- har højhastigheds internetadgang
Eksklusionskriterier
- en personlig historie med tyktarmskræft
- en personlig historie om brystkræft
- en personlig historie om kolorektale polypper
- en personlig historie med inflammatorisk tarmsygdom
- har nogen medicinske tilstande, der ville forbyde en mammografi eller CRC-screening
- har allerede haft CRC-screening
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: FOREBYGGELSE
- Tildeling: TILFÆLDIGT
- Interventionel model: FAKTORIELT
- Maskning: INGEN
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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PLACEBO_COMPARATOR: Sædvanlig pleje (UC)
Den sædvanlige plejegruppe modtog sædvanlig pleje, der varierer afhængigt af praksismiljøet.
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Intervention: Den sædvanlige plejegruppe modtog sædvanlig pleje, der varierer afhængigt af praksismiljøet.
Andre navne:
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ACTIVE_COMPARATOR: TIWeb
TIWeb (Tailored Web Intervention) program er interaktivt og skræddersyet til deltagerens individuelle overbevisning og demografi.
Personer, der modtager TIWeb, vil få information, der gør det muligt for dem at ringe og modtage et FOBT-kit med posten eller planlægge en passende CRC-test og/eller mammografi.
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Intervention: TIWeb-programmet er interaktivt og skræddersyet til deltagerens individuelle overbevisning og demografi.
Personer, der modtager TIWeb, vil få information, der gør det muligt for dem at ringe og modtage et FOBT-kit med posten eller planlægge en passende CRC-test og/eller mammografi.
Andre navne:
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ACTIVE_COMPARATOR: Kræftscreeningsopkald (CSC)
CSC - et telefonrådgivningsopkald, hvor deltageren får mulighed for at gennemføre CRC-screening (FOBT eller en koloskopi) og/eller mammografiscreening. CSC'et omfattede skræddersyet rådgivning samt muligheden for at planlægge BC- og CRC-screeningstest.
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Intervention: CSC - et telefonrådgivningssamtale, hvor deltageren får mulighed for at gennemføre CRC-screening (FOBT eller en koloskopi) og/eller mammografiscreening. CSC'et omfattede skræddersyet rådgivning samt mulighed for at planlægge BC- og CRC-screeningstest.
Andre navne:
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ACTIVE_COMPARATOR: TIWeb+CSC
TIWeb + CSC ((Skræddersyet webintervetion+Cancerscreening) gruppe modtager et mailet TIWeb, som efter fire uger følges af en CSC med samme mulighed for at modtage FOBT-sæt eller planlægge en koloskopi og/eller mammografi.
Sygeplejerskerådgiveren, der ved, at deltageren er en god kandidat til screeningstests, vil blive trænet i at planlægge CRC- eller BC-screeningsaftaler eller til at sende FOBT-sæt til personer i interventionsgrupperne, selvom de ikke har haft et nyligt besøg på klinikken.
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Intervention: TIWeb + CSC ((skræddersyet webintervetion+Cancerscreening) gruppe modtager et TIWeb tilsendt, som efter fire uger følges af en CSC med samme mulighed for at modtage FOBT-sæt eller planlægge en koloskopi og/eller mammografi.
Sygeplejerskerådgiveren, der ved, at deltageren er en god kandidat til screeningstests, vil blive trænet i at planlægge CRC- eller BC-screeningsaftaler eller til at sende FOBT-sæt til personer i interventionsgrupperne, selvom de ikke har haft et nyligt besøg på klinikken.
Andre navne:
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Primært resultat - forskelle i overholdelse af CRC-screening, når der kontrolleres for overholdelse af BC-screening ved baseline, blandt kvinder, der er randomiseret til 1) sædvanlig pleje; 2) et TIWeb; 3) en CSC og 4) en TIWeb plus en CSC.
Tidsramme: 6 måneder fra basismålet
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enhver CRC-test (enten en afføringstest eller koloskopi) modtagelse af en afføringstest eller en koloskopi
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6 måneder fra basismålet
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Primært resultat: forskelle i adoptionsstadiet (forovervejelse, kontemplation, handling) ved kontrol for overholdelse af BC-screening ved baseline blandt kvinder, der er randomiseret til 1) sædvanlig pleje; 2) et TIWeb; 3) en CSC og 4) en TIWeb plus en CSC.
Tidsramme: 6 måneder fra basismålet
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Fremadgående scenebevægelse er det ønskede resultat - bestemmende for enhver fremadgående fasebevægelse ved overvejelse af CRC-screening enten fra forkontemplation til kontemplation eller fra forkontemplation til handling
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6 måneder fra basismålet
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Sekundært resultat: Interventionsomkostninger
Tidsramme: 6 måneder fra basismålet
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Ved at sammenligne omkostningseffektiviteten af fire betingelser for at fremme CRC- og BC-screening vil der være forskelle i overholdelse af både CRC- og BC-screening og adoptionsstadiet blandt kvinder, der er randomiseret til 1) sædvanlig pleje; 2) et TIWeb; 3) en CSC og 4) en TIWeb plus en CSC.
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6 måneder fra basismålet
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Victoria Champion, PhD, Indiana University School of Medicine
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
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- Champion VL, Christy SM, Rakowski W, Lairson DR, Monahan PO, Gathirua-Mwangi WG, Stump TE, Biederman EB, Kettler CD, Rawl SM. An RCT to Increase Breast and Colorectal Cancer Screening. Am J Prev Med. 2020 Aug;59(2):e69-e78. doi: 10.1016/j.amepre.2020.03.008.
- Lairson DR, Chung TH, Huang D, Stump TE, Monahan PO, Christy SM, Rawl SM, Champion VL. Economic Evaluation of Tailored Web versus Tailored Telephone-Based Interventions to Increase Colorectal Cancer Screening among Women. Cancer Prev Res (Phila). 2020 Mar;13(3):309-316. doi: 10.1158/1940-6207.CAPR-19-0376. Epub 2020 Jan 22.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (FAKTISKE)
22. juli 2010
Primær færdiggørelse (FAKTISKE)
15. september 2015
Studieafslutning (FAKTISKE)
31. maj 2017
Datoer for studieregistrering
Først indsendt
22. august 2017
Først indsendt, der opfyldte QC-kriterier
8. september 2017
Først opslået (FAKTISKE)
12. september 2017
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (FAKTISKE)
12. september 2017
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
8. september 2017
Sidst verificeret
1. september 2017
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 1009001808
- 5R01CA136940-05 (NIH)
Plan for individuelle deltagerdata (IPD)
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JA
IPD-planbeskrivelse
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IPD-delingstidsramme
1. januar 2017 - 31. marts 2020.
IPD-delingsadgangskriterier
Forskningspersonale, der udelukkende er tilknyttet studiet og/eller kandidat- eller post-doc-studerende - som skriver relaterede manuskripter - som har fået tilladelse fra hovedefterforskeren, Victoria Champion, kan indsende en anmodning.
IPD-deling Understøttende informationstype
- STUDY_PROTOCOL
- ICF
- ANALYTIC_CODE
- CSR
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Ingen
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ingen
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