- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT01569620
Improving Colorectal Cancer Screening for Diverse Hispanics in Urban Primary Care
28 januari 2016 uppdaterad av: Icahn School of Medicine at Mount Sinai
Improving Colorectal Cancer (CRC) Screening for Diverse Hispanics in an Urban Primary Care Setting
The proposed study seeks to investigate the impact of a culturally targeted print educational intervention on rates of colorectal cancer (CRC) screening via colonoscopy among Hispanics.
If, as expected, the addition of culturally targeted materials to best clinical practices as compared to a) best clinical practices plus standard materials or b) best clinical practices alone leads to higher rates of CRC screening via colonoscopy then the culturally targeted print educational materials can be easily disseminated among this rapidly growing minority group who have low rates of CRC screening and whose disease is detected at later, less curable stages.
Studieöversikt
Status
Avslutad
Betingelser
Detaljerad beskrivning
CRC is the 2nd leading cause of cancer death among Hispanic women and men.
Hispanics are more likely to be diagnosed at more advanced disease stages compared to non-Hispanic whites and have a lower probability of survival.
A key way to decrease mortality from CRC among Hispanics is to increase rates of CRC screening and thereby early detection of CRC.
To address low screening rates, thereby increasing the prevention and early detection of CRC, the proposed research seeks to increase CRC colonoscopy screening among Hispanics.
The primary aim is to investigate the impact of a culturally targeted print educational intervention designed to increase CRC screening via colonoscopy in a diverse group of Hispanics 50 years of age and older.
Our long standing (since 1999) research platform has included significant community input through ongoing meetings with our Community Advisory Board (CAB) soliciting their viewpoints and concerns.
In addition, we consult with key community members on an ongoing basis for additional input.
A Randomized Clinical Trial (RCT) will be conducted with 400 Hispanics within the context of the best clinical practices currently provided at Mount Sinai.
There are three study arms: 1) best clinical practices plus culturally relevant print materials, 2) best clinical practices plus standard print materials and 3) best clinical practices alone.
These three arms will allow the investigation of the addition of print materials and the comparison of culturally relevant to standard print materials to assess the differential impact of each print format.
This comparison controls for the possible benefit of adding standard print materials to best clinical practices and allows for investigation of the additional benefit of culturally targeted relevant materials over and above that of standard materials.
Further, by including feedback from the community, we will be able to clearly understand the benefits of, and be able to disseminate culturally targeted materials among this rapidly growing minority group.
If, as hypothesized, the addition of the culturally targeted print materials leads to higher rates of colonoscopy, they can then be easily disseminated among health care settings treating Hispanics.
Studietyp
Interventionell
Inskrivning (Faktisk)
386
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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New York
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New York, New York, Förenta staterna, 10029
- Icahn School of Medicine at Mount Sinai
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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 85 år (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
Inclusion Criteria:
- Self-identified Hispanic
- Between the ages of 50 and 85
- Able to provide informed consent in either English or Spanish
- No participation in study Focus Groups by a family member or oneself
- Referred for a screening colonoscopy by a primary care physician at Mount Sinai
- At average risk for developing colorectal cancer
- Have no colonoscopy procedure within the last 5 years
- Have telephone service
Exclusion Criteria:
- Personal history of CRC
- Personal history of any chronic GI disorder (irritable bowel syndrome, colitis) and
- Family history of CRC (first degree relative of CRC)
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: Parallellt uppdrag
- Maskning: Enda
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Aktiv komparator: Culturally targeted print materials
Best clinical practices plus culturally print materials
|
This intervention arm includes best clinical practices (or usual care at MSSM) and the culturally relevant print materials developed for this study.
|
|
Aktiv komparator: Standard print materials
Best clinical practices plus standard print materials
|
This intervention arm includes best clinical practices (or usual care at MSSM) and the standard CRC screening print materials developed by the Centers for Disease Control (CDC).
|
|
Aktiv komparator: Best clinical practices alone
Best clinical practices alone: This intervention arm includes best clinical practices (or standard/usual care at MSSM) and no additional print materials.
|
This intervention arm includes best clinical practices (or standard/usual care at MSSM) and no additional print materials.
Andra namn:
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Change from baseline of colonoscopy at 3 months, 6 months, and 12 months.
Tidsram: Baseline, at 3 months, at 6 months, and at 12 months
|
Comparison of physician recommended colonoscopy (post intervention) obtained at approximately 3 months and 6 months (via self report) and at 12 months (as per chart review), to that of colonoscopy obtained at baseline.
|
Baseline, at 3 months, at 6 months, and at 12 months
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Samarbetspartners
Utredare
- Huvudutredare: Katherine DuHamel, PhD, Memorial Sloan Kettering Cancer Center
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.
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
1 april 2012
Primärt slutförande (Faktisk)
1 december 2015
Avslutad studie (Faktisk)
1 december 2015
Studieregistreringsdatum
Först inskickad
29 mars 2012
Först inskickad som uppfyllde QC-kriterierna
30 mars 2012
Första postat (Uppskatta)
3 april 2012
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
29 januari 2016
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
28 januari 2016
Senast verifierad
1 januari 2016
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- GCO 08-1159
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .