- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT02419846
Informed Decision Making Intervention in Screening for Prostate Cancer of Predominantly African American Participants in a Community Outreach Program
The Effectiveness of a Proposed Prostate Cancer Outreach Program in a Predominantly African American Community That Promotes Informed Decision-making for Prostate Cancer Screening and Utilizes Community Navigation
Aperçu de l'étude
Statut
Les conditions
Description détaillée
PRIMARY OBJECTIVES:
(A) To assess the effectiveness of a proposed educational model for informed decision about Prostate Cancer in high risk men over age 40 which compares informed decision making and shared decision making (B) to improve knowledge about prostate cancer in men over age 18
OUTLINE:
Participants complete an educational intervention comprising a 10-20 minute PowerPoint presentation given by an experienced healthcare professional that discusses prostate cancer facts, screening guidelines, risks, benefits, and consequences. Some participants then undergo a screening exam comprising a prostate specific antigen level and digital rectal exam.
After completion of study, participants are followed up periodically.
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
-
-
Ohio
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Cleveland, Ohio, États-Unis, 44106-5065
- Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- Men over the age of 18 will be asked to participate in the educational component of the program; men over the age of 40 will be offered the screening component after the educational portion of the event; participants over age of 40 will have the opportunity to make an informed decision in regards to prostate cancer screening based on this information and the educational material; American Cancer Society (ACS) guidelines recommend having a discussion about screening in men who have an expected mortality of greater than 10 years; data on comorbidities and 10-year mortalities will be collected on every participant using the University of California at San Francisco (UCSF) mortality index
- Educational component: men over the age of 18
- Screening component: men over age 40
Exclusion Criteria:
- Known personal history of prostate cancer
- Active malignancy, metastatic disease, or anyone undergoing treatment for malignancy
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Dépistage
- Répartition: Non randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
---|---|
Expérimental: Men over 40: Screening with intervention
Participants over the age of 40 complete an educational intervention comprising a 10-20 minute PowerPoint presentation given by an experienced healthcare professional that discusses prostate cancer facts, screening guidelines, risks, benefits, and consequences.
Participants may undergo a screening exam comprising a prostate specific antigen level and digital rectal exam.
|
Attend 10-20 minute PowerPoint presentation that will discuss prostate cancer facts, screening guidelines, risks, benefits, and consequences
Autres noms:
Undergo digital rectal exam by a licensed healthcare professional.
The results of this exam will be subjective as per clinician; however, will be coded as normal or abnormal.
This is considered standard of care for prostate cancer screening
Autres noms:
15 questions which test participants' knowledge of prostate cancer according to ACS guidelines.
Questions will be multiple choices and true/false/unsure answers
Autres noms:
Survey will be administered at the end of the program for participants to assess their experience
Autres noms:
PSA levels will be drawn and run as per institutional Laboratory standards.
Criteria for referral and follow up will be assessed as per National Comprehensive Cancer Network (NCCN) guidelines
Autres noms:
Post test will include the same 15 questions as on the pretest to assess for improvement in knowledge and understanding
Autres noms:
|
Expérimental: Men 18-39: Educational intervention
Participants between 18 and 39 complete an educational intervention comprising a 10-20 minute PowerPoint presentation given by an experienced healthcare professional that discusses prostate cancer facts, screening guidelines, risks, benefits, and consequences.
|
Attend 10-20 minute PowerPoint presentation that will discuss prostate cancer facts, screening guidelines, risks, benefits, and consequences
Autres noms:
15 questions which test participants' knowledge of prostate cancer according to ACS guidelines.
Questions will be multiple choices and true/false/unsure answers
Autres noms:
Survey will be administered at the end of the program for participants to assess their experience
Autres noms:
Post test will include the same 15 questions as on the pretest to assess for improvement in knowledge and understanding
Autres noms:
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Proportion of participants over age 18 that demonstrate improved knowledge about prostate cancer screening
Délai: Up to 1 year
|
Improved understanding will be defined as an increase in the number of correct answers seen on the post Prostate Screening Education Questionnaire.
The underlying likelihood of a positive response, or improved understanding of prostate cancer screening, can be estimated using a 95% confidence interval that has a maximum half-width of 6%.
|
Up to 1 year
|
Proportion of participants over age 40 who find this education and screening model helpful in making an informed decision about prostate cancer screening as measured by the satisfaction survey questions
Délai: Up to 1 year
|
Helpfulness of the program will be measured on a 5-point Likert scale where the two uppermost categories are considered a positive response.
|
Up to 1 year
|
Mesures de résultats secondaires
Mesure des résultats |
Délai |
---|---|
Proportion of participants who choose to enter the clinical trial
Délai: Up to 1 year
|
Up to 1 year
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Proportion of participants who choose screening after educational intervention
Délai: Up to 1 year
|
Up to 1 year
|
10-year expected mortality based on USCF 10-year Mortality Index for all participants
Délai: Up to 1 year
|
Up to 1 year
|
Proportion of participants with a high 10-year mortality based on UCSF index who choose to be screened for prostate cancer after educational intervention
Délai: Up to 1 year
|
Up to 1 year
|
Proportion of abnormal results found with screening and referred to follow-up assessed as per National Comprehensive Cancer Network guidelines
Délai: Up to 1 year
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Up to 1 year
|
Proportion of participants diagnosed with malignancy based on follow up biopsies and work-up during the course of the study
Délai: Up to 1 year
|
Up to 1 year
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Proportion of participants with family history of prostate cancer
Délai: Up to 1 year
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Up to 1 year
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Proportion of participants referred to a primary care physician who did not previously have a primary care physician
Délai: Up to 1 year
|
Up to 1 year
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Proportion of participants who asked the physician to make a decision for them in spite of educational intervention
Délai: Up to 1 year
|
Up to 1 year
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Proportion of participants who expressed satisfied with this proposed informed consent and education model
Délai: Up to 1 year
|
Up to 1 year
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Samir Abraksia, MD, Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer 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 (Estimation)
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
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- CASE3815
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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