- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT01801059
Patient Activation Intervention in Improving Screening Rates for Colorectal Cancer
Patient Activation To Increase Colon Cancer Screening (THE CHAT STUDY)
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
PRIMARY OBJECTIVES:
I. To test a patient activation intervention to improve colorectal cancer (CRC) screening rates using fecal occult blood test (FOBT) among male and female patients 50 years and older from the East Central Columbus Neighborhood Health Center.
SECONDARY OBJECTIVES:
I. To assess if there is a change in knowledge and attitudes about CRC screening after watching the educational video.
II. To assess the effectiveness of providing communication skills training for improving discussion focusing on CRC screening during the patient-provider visit.
OUTLINE: Patients are randomized to 1 of 2 arms prior to a medical visit.
ARM I (Education only): Patients receive CRC and CRC screening information by an educational video and a brochure with healthy hints to prevent CRC.
ARM II (Education and patient activation): Patients receive CRC and CRC screening information and communication skills training (patient activation) intervention by educational video and brochure and a brochure about healthy hints to prevent CRC.
After the medical visit, patients' medical records are reviewed at 1 month and 2 months after the visit to document CRC screening completion.
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
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Ohio
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Columbus, Ohio, États-Unis, 43210
- Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- Patient is 50+ years of age
- Patient is in need of CRC screening
- Patient is in good health (e.g. no contraindications to having CRC screening, such as a history of colorectal cancer, congenital heart failure, renal failure, dialysis, dementia, severe arthritis, etc.)
- Patient is not pregnant
- Patient is able to speak, read, and understand English
Exclusion Criteria:
- Patient is within CRC screening guidelines
- Patient is at high risk for CRC
- Patient cannot understand English
- Patient cannot complete a CRC screening test
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Dépistage
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
---|---|
Comparateur actif: Arm I education CRC and CRC screening
Educational intervention: Patients receive CRC and CRC screening information from an educational video and received a brochure focused on healthy hints to prevent CRC.
Questionnaire administration prior to and after the intervention.
|
Etudes annexes
Receive patient activation intervention by educational video and brochure
Autres noms:
Receive patient activation intervention by educational video
Autres noms:
|
Expérimental: Arm II education and patient activation intervention
Educational intervention administered: Patients receive patient activation intervention comprising CRC and CRC screening information and communication skills training intervention by educational video and brochure, and they also receive a brochure focused on healthy hints to prevent CRC.
Questionnaire administration prior to and after the intervention.
|
Etudes annexes
Receive patient activation intervention by educational video and brochure
Autres noms:
Receive patient activation intervention by educational video
Autres noms:
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Completion rate of CRC screening
Délai: Up to 2 months
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A test of two proportions will be used.
If the two groups are different at baseline with respect to key covariates, then a logistic regression model will be used to assess the effect of the intervention on CRC screening controlling for possible confounding variables.
The variables that differ between the two groups will be tested as confounders using risk-factor modeling.
Summary statistics will be used to describe the time point that subjects receive CRC screening, either after the medical visit or after telephone barriers counseling, and relevant comparisons made.
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Up to 2 months
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Collaborateurs et enquêteurs
Les enquêteurs
- Chercheur principal: Mira Katz, Ohio State University Comprehensive Cancer Center
Publications et liens utiles
Liens utiles
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- OSU-07104
- NCI-2012-01922 (Identificateur de registre: CTRP (Clinical Trial Reporting Program))
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .
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