Essai pilote évaluant l'impact de Protect Your Colon™ sur le dépistage du CCR
Essai contrôlé randomisé pilote évaluant l'impact de Protect Your Colon™ sur les comportements de dépistage du cancer colorectal
The purpose of the research is to assess the impact of Protect Your Colon™, a colorectal cancer (CRC) screening decision aid, on patients' CRC screening behaviors. The Investigators hypothesize that Protect Your Colon™, through optimizing shared decision making, will lead to selection of a test that accurately matches patients' values and increase CRC screening uptake. To test this hypothesis, the investigators will conduct a pilot randomized controlled trial (RCT) to assess if provision of Protect Your Colon™ improves communication on CRC screening, intent to complete screening, and ultimately uptake of screening vs. usual care.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
-
-
California
-
Los Angeles, California, États-Unis, 90048
- Cedars-Sinai Medical Center
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- Individuals 45 to 75 years old
- No prior CRC screening or not up-to-date with CRC screening
- Not at high risk for CRC (e.g., inflammatory bowel disease, colon polyposis syndromes, family history of CRC)
- No prior colon polyps
- Additional inclusion criteria for participants recruited through Cint online survey panels: (i) appointment with a primary care provider up to 6 weeks from time of screening, and (ii) have Preferred Provider Organization (PPO) insurance.
Exclusion Criteria:
- Does not speak English
- Does not have internet access
- Any records flagged "break the glass" or "research opt out."
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Dépistage
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Double
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: Protect Your Colon™ (Intervention)
Patients randomized to Protect Your Colon™ will be directed to go through the website before their clinic appointment. Those who finish the decision aid will then review their personalized report which details their priorities in selecting a screening test as well as the test that best matches their values. Patients will also be encouraged to bring their personalized report with them to the visit to discuss with their doctor. All intervention participants will also receive a reminder via email one day before their scheduled clinic visit. They will be reminded to go through the Protect Your Colon™ website before the clinic visit and to bring their personalized report with them to the visit. |
Protect Your Colon™ is an online decision aid focused on CRC screening. The site will first educate patients on the importance of CRC screening and offer information on the advantages and disadvantages of the available test options. Protect Your Colon™ will then present an interactive conjoint analysis-a quantitative survey technique that elucidates how individuals make complex decisions-to precisely determine individuals' latent preferences regarding CRC screening options. Afterwards, the app will generate a personalized report that rank orders the importance of each test attribute (e.g., accuracy, invasiveness, test frequency) in patients' decision making and identifies the screening modality that best matches their preferences. The report will also be shareable with physicians, enabling patients and providers to engage in shared decision making surrounding CRC screening in the clinic. |
|
Aucune intervention: Usual Care (Control)
The usual care group will be managed according to the providers' customary practices: CRC screening discussions, if any, are at the discretion of the provider as Cedars-Sinai does not employ a standardized approach. Patients randomized to the control arm will not be sent any materials before their clinic appointment. |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Rate of completion of a CRC screening test
Délai: 6 months post visit
|
Uptake of CRC screening within 6 months of patients' initial visit |
6 months post visit
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Qualitative feedback on details of CRC screening test
Délai: 1 day post visit
|
Completion of questionnaire that looks at:
|
1 day post visit
|
Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Les enquêteurs
- Chercheur principal: Christopher V Almario, MD, MSHPM, Cedars-Sinai Medical Center
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
Autres numéros d'identification d'étude
- STUDY2402
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Description du régime IPD
The data that support the findings of this study will be available from the principal investigator (Christopher V. Almario) upon reasonable request.
Délai de partage IPD
Data will become available after study completion and for up to 3 years after study completion.
Critères d'accès au partage IPD
The data that support the findings of this study will be available from the principal investigator (Christopher V. Almario) upon reasonable request.
Type d'informations de prise en charge du partage d'IPD
- PROTOCOLE D'ÉTUDE
- SÈVE
- CIF
- ANALYTIC_CODE
- RSE
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
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