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Informed Decision Making Intervention in Screening for Prostate Cancer of Predominantly African American Participants in a Community Outreach Program

21 juillet 2022 mis à jour par: Case Comprehensive Cancer Center

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

This clinical trial studies an informed decision making intervention of screening for prostate cancer in predominantly African American participants. It also evaluates participants' knowledge about prostate cancer screening and to improve understanding. Using decision aids such as culturally sensitive written material, verbal information, and videos to educate patients about screening may increase patient participation and knowledge. This may increase confidence in participants' decisions. Raising awareness about prostate cancer in the communities may increase the participants' willingness to be screened for prostate cancer once they have learned about it.

Aperçu de l'étude

Statut

Résilié

Les conditions

Intervention / Traitement

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

Interventionnel

Inscription (Réel)

319

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

  • États-Unis
    • Ohio
      • Cleveland, Ohio, États-Unis, 44106-5065
        • Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

19 ans et plus (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Oui

Sexes éligibles pour l'étude

Homme

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

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

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.
Autre: Educational Intervention
Attend 10-20 minute PowerPoint presentation that will discuss prostate cancer facts, screening guidelines, risks, benefits, and consequences
Autres noms:
  • Intervention, Éducatif
  • PowerPoint Presentation
Procédure: digital rectal examination
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:
  • ERD
Autre: Pre-test administration
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:
  • gestion des questionnaires
Autre: Survey Administration
Survey will be administered at the end of the program for participants to assess their experience
Autres noms:
  • Program Evaluation
Autre: Prostate-specific antigen measurement
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:
  • PSA levels
Autre: Post test administration
Post test will include the same 15 questions as on the pretest to assess for improvement in knowledge and understanding
Autres noms:
  • gestion des questionnaires
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.
Autre: Educational Intervention
Attend 10-20 minute PowerPoint presentation that will discuss prostate cancer facts, screening guidelines, risks, benefits, and consequences
Autres noms:
  • Intervention, Éducatif
  • PowerPoint Presentation
Autre: Pre-test administration
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:
  • gestion des questionnaires
Autre: Survey Administration
Survey will be administered at the end of the program for participants to assess their experience
Autres noms:
  • Program Evaluation
Autre: Post test administration
Post test will include the same 15 questions as on the pretest to assess for improvement in knowledge and understanding
Autres noms:
  • gestion des questionnaires

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
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
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
Proportion of participants with family history of prostate cancer
Délai: Up to 1 year
Up to 1 year
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
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
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

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Case Comprehensive Cancer Center

Les enquêteurs

  • Chercheur principal: Samir Abraksia, MD, Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

1 juin 2015

Achèvement primaire (Réel)

1 octobre 2021

Achèvement de l'étude (Réel)

1 juillet 2022

Dates d'inscription aux études

Première soumission

14 avril 2015

Première soumission répondant aux critères de contrôle qualité

14 avril 2015

Première publication (Estimation)

17 avril 2015

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

25 juillet 2022

Dernière mise à jour soumise répondant aux critères de contrôle qualité

21 juillet 2022

Dernière vérification

1 juillet 2022

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

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

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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