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

21. Juli 2022 aktualisiert von: 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.

Studienübersicht

Status

Beendet

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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.

Studientyp

Interventionell

Einschreibung (Tatsächlich)

319

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

  • Vereinigte Staaten
    • Ohio
      • Cleveland, Ohio, Vereinigte Staaten, 44106-5065
        • Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

19 Jahre und älter (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Ja

Studienberechtigte Geschlechter

Männlich

Beschreibung

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

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Screening
  • Zuteilung: Nicht randomisiert
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: 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.
Sonstiges: Educational Intervention
Attend 10-20 minute PowerPoint presentation that will discuss prostate cancer facts, screening guidelines, risks, benefits, and consequences
Andere Namen:
  • Intervention, pädagogisch
  • PowerPoint Presentation
Verfahren: 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
Andere Namen:
  • DRE
Sonstiges: 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
Andere Namen:
  • Fragebogenverwaltung
Sonstiges: Survey Administration
Survey will be administered at the end of the program for participants to assess their experience
Andere Namen:
  • Program Evaluation
Sonstiges: 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
Andere Namen:
  • PSA levels
Sonstiges: Post test administration
Post test will include the same 15 questions as on the pretest to assess for improvement in knowledge and understanding
Andere Namen:
  • Fragebogenverwaltung
Experimental: 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.
Sonstiges: Educational Intervention
Attend 10-20 minute PowerPoint presentation that will discuss prostate cancer facts, screening guidelines, risks, benefits, and consequences
Andere Namen:
  • Intervention, pädagogisch
  • PowerPoint Presentation
Sonstiges: 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
Andere Namen:
  • Fragebogenverwaltung
Sonstiges: Survey Administration
Survey will be administered at the end of the program for participants to assess their experience
Andere Namen:
  • Program Evaluation
Sonstiges: Post test administration
Post test will include the same 15 questions as on the pretest to assess for improvement in knowledge and understanding
Andere Namen:
  • Fragebogenverwaltung

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Proportion of participants over age 18 that demonstrate improved knowledge about prostate cancer screening
Zeitfenster: 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
Zeitfenster: 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

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Zeitfenster
Proportion of participants who choose to enter the clinical trial
Zeitfenster: Up to 1 year
Up to 1 year
Proportion of participants who choose screening after educational intervention
Zeitfenster: Up to 1 year
Up to 1 year
10-year expected mortality based on USCF 10-year Mortality Index for all participants
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: Up to 1 year
Up to 1 year
Proportion of participants with family history of prostate cancer
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: Up to 1 year
Up to 1 year
Proportion of participants who expressed satisfied with this proposed informed consent and education model
Zeitfenster: Up to 1 year
Up to 1 year

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Case Comprehensive Cancer Center

Ermittler

  • Hauptermittler: Samir Abraksia, MD, Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

1. Juni 2015

Primärer Abschluss (Tatsächlich)

1. Oktober 2021

Studienabschluss (Tatsächlich)

1. Juli 2022

Studienanmeldedaten

Zuerst eingereicht

14. April 2015

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

14. April 2015

Zuerst gepostet (Schätzen)

17. April 2015

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

25. Juli 2022

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

21. Juli 2022

Zuletzt verifiziert

1. Juli 2022

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • CASE3815

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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