Ökad screening av kolorektal och bröstcancer hos kvinnor (COBRA)
8 september 2017 uppdaterad av: Victoria L. Champion, Indiana University
Denna studie jämför effektiviteten (vidhäftning och stadium) av fyra interventioner för att främja screening av kolorektal (CRC) och bröstcancer (BC) bland kvinnor i åldrarna 50 till 75. Dom är:
- vanlig vård;
- en TIWeb (skräddarsydd interventionswebbplats)
- ett CSC (cancerscreening call) och
- TIWeb + en CSC. Denna studie jämför också kostnadseffektiviteten för de fyra interventionerna för att främja CRC- och BC-screening bland kvinnor i åldrarna 50 till 75.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Detaljerad beskrivning
Denna studie tar upp innovativa metoder för att öka följsamheten till screeningtest för kolorektal och bröstcancer - två cancerformer som har störst inverkan på kvinnlig cancerdödlighet i USA. Cancerbördan hos kvinnor skulle kunna minskas avsevärt genom att öka deltagandet i rekommenderad screening för kolorektal cancer (CRC) och bröstcancer (BC) hos alla berättigade kvinnor.
Denna forskning testar intervention för att samtidigt öka både CRC- och BC-screening med hjälp av beteendeförändringsstrategier, och uppskattar även effektiviteten och kostnadseffektiviteten av interventionerna.
Två grupper av kvinnor, grupp A (följer sig till riktlinjerna för BC-screening, men INTE till CRC-screeningsriktlinjerna) och Grupp B (som inte följer BC- och CRC-riktlinjerna) är randomiserade till 1. Usual Care, 2. TIWeb, 3. CSC och 4. TIWeb +CSC.
Studietyp
Interventionell
Inskrivning (Faktisk)
1196
Fas
- Inte tillämpbar
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
50 år till 75 år (VUXEN, OLDER_ADULT)
Tar emot friska volontärer
Ja
Kön som är behöriga för studier
Kvinna
Beskrivning
Inklusionskriterier:
- en patient av någon av de deltagande läkarna
- inte ha haft ett fekalt ockult blodprov (fobt) under de senaste 12 månaderna
- inte ha haft ett avföringsimmunokemiskt test (passform) under de senaste 15 månaderna
- inte haft sigmoidoskopi för mer än 5 år sedan
- inte ha gjort en koloskopi för mer än 10 år sedan
- har tillgång till höghastighetsinternet
Exklusions kriterier
- en personlig historia av kolorektal cancer
- en personlig historia av bröstcancer
- en personlig historia av kolorektala polyper
- en personlig historia av inflammatorisk tarmsjukdom
- har några medicinska tillstånd som skulle förbjuda en mammografi eller CRC-screening
- har redan genomgått CRC-screening
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: FÖREBYGGANDE
- Tilldelning: RANDOMISERAD
- Interventionsmodell: FAKTORIELL
- Maskning: INGEN
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
PLACEBO_COMPARATOR: Vanlig vård (UC)
Den vanliga vårdgruppen fick vanlig vård som varierar beroende på praktikinställningen.
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Intervention: Den vanliga vårdgruppen fick vanlig vård som varierar beroende på praktikinställningen.
Andra namn:
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ACTIVE_COMPARATOR: TIWeb
TIWeb-programmet (Tailored Web Intervention) är interaktivt och skräddarsytt för deltagarens individuella övertygelser och demografi.
Individer som tar emot TIWeb kommer att få information som gör att de kan ringa och ta emot ett FOBT-kit med posten eller schemalägga ett lämpligt CRC-test och/eller mammografi.
|
Intervention: TIWeb-programmet är interaktivt och skräddarsytt för deltagarens individuella övertygelse och demografi.
Individer som tar emot TIWeb kommer att få information som gör att de kan ringa och ta emot ett FOBT-kit med posten eller schemalägga ett lämpligt CRC-test och/eller mammografi.
Andra namn:
|
|
ACTIVE_COMPARATOR: Cancer Screening Call (CSC)
CSC - ett telefonrådgivningssamtal under vilket deltagaren ges möjlighet att genomföra CRC-screening (FOBT eller en koloskopi) och/eller mammografiscreening. CSC inkluderade skräddarsydd rådgivning samt möjligheten att schemalägga BC- och CRC-screeningtest.
|
Intervention: CSC - ett telefonrådgivningssamtal under vilket deltagaren ges möjlighet att genomföra CRC-screening (FOBT eller en koloskopi) och/eller mammografiscreening. CSC inkluderade skräddarsydd rådgivning samt möjligheten att schemalägga BC- och CRC-screeningtest.
Andra namn:
|
|
ACTIVE_COMPARATOR: TIWeb+CSC
TIWeb + CSC ((skräddarsydd webbintervetion+cancerscreening) grupp får en postad TIWeb, som efter fyra veckor följs av en CSC med samma möjlighet att få FOBT-kit eller schemalägga en koloskopi och/eller mammografi.
Sjuksköterskerådgivaren, som vet att deltagaren är en bra kandidat för screeningtest, kommer att utbildas i att schemalägga CRC- eller BC-screeningmöten eller att skicka FOBT-kit till individer i interventionsgrupperna även om de inte har haft ett nyligen besökt klinik.
|
Intervention: TIWeb + CSC ((skräddarsydd webbintervetion+cancerscreening) grupp får en postad TIWeb, som efter fyra veckor följs av en CSC med samma möjlighet att få FOBT-kit eller schemalägga en koloskopi och/eller mammografi.
Sjuksköterskerådgivaren, som vet att deltagaren är en bra kandidat för screeningtest, kommer att utbildas i att schemalägga CRC- eller BC-screeningmöten eller att skicka FOBT-kit till individer i interventionsgrupperna även om de inte har haft ett nyligen besökt klinik.
Andra namn:
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Primärt utfall -skillnader i följsamhet vid CRC-screening, vid kontroll för följsamhet till BC-screening vid baslinjen, bland kvinnor som är randomiserade till 1) vanlig vård; 2) en TIWeb; 3) en CSC och 4) en TIWeb plus en CSC.
Tidsram: 6 månader från baslinjemåttet
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något CRC-test (antingen ett avföringstest eller koloskopi) mottagande av ett avföringstest eller en koloskopi
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6 månader från baslinjemåttet
|
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Primärt resultat:skillnader i adoptionsstadium (förbegrundande, kontemplation, handling) vid kontroll av efterlevnad av BC-screening vid baslinjen, bland kvinnor som är randomiserade till 1) vanlig vård; 2) en TIWeb; 3) en CSC och 4) en TIWeb plus en CSC.
Tidsram: 6 månader från baslinjemåttet
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Framåtstegsrörelse är det önskade resultatet - som bestämmer varje steg framåt vid övervägande av CRC-screening antingen från förkontemplation till kontemplation eller från förkontemplation till handling
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6 månader från baslinjemåttet
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Sekundärt utfall: Interventionskostnader
Tidsram: 6 månader från baslinjemåttet
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Om man jämför kostnadseffektiviteten för fyra tillstånd för att främja CRC- och BC-screening kommer det att finnas skillnader i efterlevnad av både CRC- och BC-screening och adoptionsstadium, bland kvinnor som är randomiserade till 1) vanlig vård; 2) en TIWeb; 3) en CSC och 4) en TIWeb plus en CSC.
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6 månader från baslinjemåttet
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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Samarbetspartners
Utredare
- Huvudutredare: Victoria Champion, PhD, Indiana University School of Medicine
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Allmänna publikationer
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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.
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (FAKTISK)
22 juli 2010
Primärt slutförande (FAKTISK)
15 september 2015
Avslutad studie (FAKTISK)
31 maj 2017
Studieregistreringsdatum
Först inskickad
22 augusti 2017
Först inskickad som uppfyllde QC-kriterierna
8 september 2017
Första postat (FAKTISK)
12 september 2017
Uppdateringar av studier
Senaste uppdatering publicerad (FAKTISK)
12 september 2017
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
8 september 2017
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1 september 2017
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
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- 1009001808
- 5R01CA136940-05 (NIH)
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JA
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Tidsram för IPD-delning
1 januari 2017 - 31 mars 2020.
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