Health Service Intervention for the Improvement of Access and Adherence to Colorectal Cancer Screening
Increasing Access and Developing Predictors for Colorectal Cancer Screening for Minority and Medicaid Clients
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
PRIMARY OBJECTIVES:
I. Test the feasibility of Witness CARES (WC) Services to achieve colorectal carcinoma (CRC) screening for non-adherent Medicaid clients.
II. Develop an algorithm for predicting CRC screening outcomes following intervention services.
OUTLINE:
Patients who are not prepared for a colonoscopy or stool test receive educational materials, messages, and videos electronically or by mail with information about colorectal screening and are followed up by phone within 2 weeks. Patients desiring colonoscopy receive navigator assistance with obtaining the screening (e.g.,determining gastrointestinal doctor, scheduling appointment, prep materials and process, transportation, escort). Patients desiring a stool test receive navigator assistance by facilitating fecal tests.
After completion of study, patients are followed up periodically.
Type d'étude
Inscription (Réel)
Phase
- La phase 1
Contacts et emplacements
Lieux d'étude
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New York
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Buffalo, New York, États-Unis, 14263
- Roswell Park Cancer Institute
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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:
- Participants who are non-adherent to CRC screening over the past year (i.e., no stool testing in past 11 months or colonoscopy for over 9 years)
- Medicaid or Medicaid/Medicare subscribers
- Uninsured patients may be included from Mercy Comprehensive Care Center (MCCC), but will only be eligible for services to obtain fecal immunochemical tests (FIT) through the New York State (NYS) Cancer Services Program
Exclusion Criteria:
- Any participants from the lists of gaps in care clients from insurance or primary care practices who report having had a colonoscopy in the past 9 years (or having positive findings such as polyps, 5 years) or having completed some type of fecal test for CRC will be excluded
- Participants under 50 will be excluded unless they have been deemed high risk by their physician, and have a prescription for CRC screening
- Participants symptomatic for CRC will be excluded from the study
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Recherche sur les services de santé
- Répartition: N / A
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: Health services research (Witness CARES services) Intervention
Patients who are not prepared for a colonoscopy or stool test receive educational materials, messages, and videos electronically or by mail with information about colorectal screening and are followed up by phone within 2 weeks.
Patients desiring colonoscopy, receive navigators assistance with obtaining the screening (e.g.,determining gastrointestinal doctor, scheduling appointment, prep materials and process, transportation, escort).
Patients desiring a stool test, receive navigators assistance by facilitating fecal tests.
|
Etudes annexes
Receive Witness CARES services
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Change in Screening Metrics
Délai: Up to 12 months
|
After CRC screening, satisfaction surveys will be conducted in order to assess the services of the Witness Cares Program. Below are responses to basic follow-up questions. |
Up to 12 months
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Model Development for Prediction of Intent and Colorectal Cancer (CRC) Screening Behaviors
Délai: Up to 12 months
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A telephone assessment of 118 self reported questions will be conducted in order to assess what factors are associated with CRC screening. The outcome of interest is CRC screening (colonoscopy or fecal immunochemical testing (FIT) test), which is treated as a binary outcome. The potential predictors include basic demographic characteristics as well as the survey sub-scales (based on the 118 self-reported questions). |
Up to 12 months
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Prediction of Which CRC Screening Test is Most Acceptable
Délai: Up to 12 months
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Data collected from surveys from the intent to screen clients will be used to help predict CRC screening test most acceptable
|
Up to 12 months
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Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Les enquêteurs
- Chercheur principal: Deborah Erwin, Roswell Park Cancer Institute
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
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 (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
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
- I 63518 (Autre identifiant: Roswell Park Cancer Institute)
- P30CA016056 (Subvention/contrat des NIH des États-Unis)
- NCI-2019-06075 (Identificateur de registre: CTRP (Clinical Trial Reporting Program))
- R41CA232824 (Subvention/contrat des NIH des États-Unis)
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
produit fabriqué et exporté des États-Unis.
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