- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT00786747
Randomized Controlled Trial of Tailored Interactive Multimedia to Reduce Colorectal Cancer Screening Disparities
2. Dezember 2015 aktualisiert von: Anthony F. Jerant, University of California, Davis
The study investigators have developed an interactive multimedia computer program that provides personally tailored education about colorectal cancer screening in the user's preferred language (English or Spanish).
In this study, the investigators will examine whether use of the computer program increases the number of Hispanic patients who receive colorectal cancer screening and lessens or eliminates the glaring disparity in screening between Hispanics and non-Hispanic whites.
Studienübersicht
Status
Abgeschlossen
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
- Background: Interactive multimedia computer programs (IMCPs) show promise as a way of delivering personally tailored (PT) information to enhance cognitive mediators of health behavior and improve patient outcomes. However, it is unclear whether PT IMCPs can be deployed in primary care offices to increase cancer screening uptake and eliminate ethnic disparities in uptake by providing PT information in each user's preferred language.
- Aims/Hypotheses: We will compare changes in colorectal cancer (CRC) screening cognitive mediators (self-efficacy, perceived barriers, and readiness) and uptake resulting from an IMCP - PT to enhance the key cognitive mediators and targeted to patients' self-identified ethnicity - with changes resulting from a non-tailored "electronic leaflet" control IMCP. The experimental and control IMCPs will each be offered in English and Spanish versions. We hypothesize that, compared with the appropriate control condition (English, Spanish, or both combined): (1) the English version of the PT IMCP will enhance the cognitive mediators of CRC screening behavior for English-speaking Hispanics and non-Hispanics; (2) there will be similarly favorable changes in these mediators for Hispanics using the Spanish version of the PT IMCP; (3) deployment of the PT IMCP will provide evidence of elimination of disparities in CRC screening between Hispanic and non-Hispanic subjects via its relative impact on the cognitive mediators in these groups; and (4) the PT IMCP (English and Spanish combined) will increase CRC screening uptake in Hispanics and non-Hispanics (considered separately) via changes in the cognitive mediators.
- Methods: Randomized controlled trial of 2 groups, comparing a PT (to the cognitive mediators) CRC screening IMCP offered in both English and Spanish versions and deployed before a primary care office visit with a non-tailored "electronic leaflet" CRC screening IMCP (control) also offered in both English and Spanish. Screening methods targeted will be fecal occult blood testing, flexible sigmoidoscopy, and colonoscopy. Primary outcomes will be CRC screening uptake, self-efficacy, perceived barriers, and readiness.
- Implications: Our findings will determine whether an IMCP that is PT to cognitive mediators of screening behavior and deployed in primary care offices prior to previously scheduled visits can activate patients of various ethnicities to undergo CRC screening. They may also suggest a promising, portable method of reducing disparities in CRC (and other) screening uptake between Hispanic and non-Hispanic individuals.
Studientyp
Interventionell
Einschreibung (Tatsächlich)
1164
Phase
- Unzutreffend
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienorte
-
-
California
-
Sacramento, California, Vereinigte Staaten, 95817
- University of California, Davis Health System
-
-
Colorado
-
Aurora, Colorado, Vereinigte Staaten, 80045
- University Of Colorado
-
-
New York
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New York City, New York, Vereinigte Staaten, 10031
- Sophie Davis School of Biomedical Education, City University of New York,
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Rochester, New York, Vereinigte Staaten, 14642
- University of Rochester School of Medicine and Dentistry
-
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Texas
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San Antonio, Texas, Vereinigte Staaten, 78229
- University of Texas Health Sciences Center
-
-
Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
50 Jahre bis 75 Jahre (Erwachsene, Älterer Erwachsener)
Akzeptiert gesunde Freiwillige
Ja
Studienberechtigte Geschlechter
Alle
Beschreibung
Inclusion Criteria:
- Receive primary care at one of the participating outpatient study offices
- Age at or above 50 years
- Able to read and speak English and/or Spanish
- Adequate vision, hearing, and hand function to use an IMCP running on a laptop computer via a touch screen interface
- Have an active telephone
- Not up to date for CRC screening. Up to date status will be defined as having completed CRC screening via: fecal occult blood test within 2 years; flexible sigmoidoscopy within 5 years; or colonoscopy within 10 years, consistent with national practice guidelines and standards.
Exclusion Criteria:
- Unable to understand the consent form or the telephone screening questionnaire due to cognitive impairment
- Unable to provide informed consent due to serious acute illness
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Screening
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Verdreifachen
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
---|---|
Experimental: Personally tailored computer program
The experimental computer program provides the user with information about colorectal cancer screening that is tailored to their self-efficacy, readiness, and perceived barriers to undergoing screening, in their preferred language (English or Spanish).
|
The experimental computer program provides the user with information about colorectal cancer screening that is tailored to their self-efficacy, readiness, and perceived barriers to undergoing screening, in their preferred language (English or Spanish).
|
Aktiver Komparator: Non-tailored control computer program
This program provides non-tailored, generic information about colorectal cancer screening, in the user's preferred language (English or Spanish).
|
This program provides users with non-tailored information about colorectal cancer screening, in their preferred language (English or Spanish).
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Zeitfenster |
---|---|
Up to date colorectal cancer screening status
Zeitfenster: 1 year
|
1 year
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Zeitfenster |
---|---|
Up to date colonoscopy screening status
Zeitfenster: 1 year
|
1 year
|
Up to date fecal occult blood testing status
Zeitfenster: 1 year
|
1 year
|
Colorectal cancer screening self-efficacy
Zeitfenster: Immediately after computer program use
|
Immediately after computer program use
|
Perceived barriers to colorectal cancer screening
Zeitfenster: Immediately after computer program use
|
Immediately after computer program use
|
Readiness to undergo colorectal cancer screening
Zeitfenster: Immediately after computer program use
|
Immediately after computer program use
|
Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Sponsor
Ermittler
- Hauptermittler: Anthony Jerant, MD, University of California, Davis
Publikationen und hilfreiche Links
Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.
Allgemeine Veröffentlichungen
- Jerant A, Sohler N, Fiscella K, Franks B, Franks P. Tailored interactive multimedia computer programs to reduce health disparities: opportunities and challenges. Patient Educ Couns. 2011 Nov;85(2):323-30. doi: 10.1016/j.pec.2010.11.012. Epub 2010 Dec 13.
- Sohler NL, Jerant A, Franks P. Socio-psychological factors in the Expanded Health Belief Model and subsequent colorectal cancer screening. Patient Educ Couns. 2015 Jul;98(7):901-7. doi: 10.1016/j.pec.2015.03.023. Epub 2015 Apr 8.
- Jerant A, Kravitz RL, Sohler N, Fiscella K, Romero RL, Parnes B, Tancredi DJ, Aguilar-Gaxiola S, Slee C, Dvorak S, Turner C, Hudnut A, Prieto F, Franks P. Sociopsychological tailoring to address colorectal cancer screening disparities: a randomized controlled trial. Ann Fam Med. 2014 May-Jun;12(3):204-14. doi: 10.1370/afm.1623.
- Jerant A, Kravitz RL, Fiscella K, Sohler N, Romero RL, Parnes B, Aguilar-Gaxiola S, Turner C, Dvorak S, Franks P. Effects of tailored knowledge enhancement on colorectal cancer screening preference across ethnic and language groups. Patient Educ Couns. 2013 Jan;90(1):103-10. doi: 10.1016/j.pec.2012.08.017. Epub 2012 Sep 15.
- Jerant A, To P, Franks P. The effects of tailoring knowledge acquisition on colorectal cancer screening self-efficacy. J Health Commun. 2015;20(6):697-709. doi: 10.1080/10810730.2015.1018562. Epub 2015 Apr 30.
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn
1. Februar 2010
Primärer Abschluss (Tatsächlich)
1. Oktober 2011
Studienabschluss (Tatsächlich)
1. November 2012
Studienanmeldedaten
Zuerst eingereicht
5. November 2008
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
5. November 2008
Zuerst gepostet (Schätzen)
6. November 2008
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Schätzen)
3. Dezember 2015
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
2. Dezember 2015
Zuletzt verifiziert
1. Dezember 2015
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- NCI -1R01CA131386-01A1
- ARRA CA13138602S1 (Andere Zuschuss-/Finanzierungsnummer: American Reinvestment and Recovery Act supplement)
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .
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