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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 opdateret af: 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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

319

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Forenede Stater
    • Ohio
      • Cleveland, Ohio, Forenede Stater, 44106-5065
        • Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

19 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Han

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Screening
  • Tildeling: Ikke-randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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.
Andet: Educational Intervention
Attend 10-20 minute PowerPoint presentation that will discuss prostate cancer facts, screening guidelines, risks, benefits, and consequences
Andre navne:
  • Intervention, pædagogisk
  • PowerPoint Presentation
Procedure: 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
Andre navne:
  • DRE
Andet: 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
Andre navne:
  • spørgeskemaadministration
Andet: Survey Administration
Survey will be administered at the end of the program for participants to assess their experience
Andre navne:
  • Program Evaluation
Andet: 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
Andre navne:
  • PSA levels
Andet: Post test administration
Post test will include the same 15 questions as on the pretest to assess for improvement in knowledge and understanding
Andre navne:
  • spørgeskemaadministration
Eksperimentel: 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.
Andet: Educational Intervention
Attend 10-20 minute PowerPoint presentation that will discuss prostate cancer facts, screening guidelines, risks, benefits, and consequences
Andre navne:
  • Intervention, pædagogisk
  • PowerPoint Presentation
Andet: 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
Andre navne:
  • spørgeskemaadministration
Andet: Survey Administration
Survey will be administered at the end of the program for participants to assess their experience
Andre navne:
  • Program Evaluation
Andet: Post test administration
Post test will include the same 15 questions as on the pretest to assess for improvement in knowledge and understanding
Andre navne:
  • spørgeskemaadministration

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Proportion of participants over age 18 that demonstrate improved knowledge about prostate cancer screening
Tidsramme: 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
Tidsramme: 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

Sekundære resultatmål

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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Case Comprehensive Cancer Center

Efterforskere

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

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

1. juni 2015

Primær færdiggørelse (Faktiske)

1. oktober 2021

Studieafslutning (Faktiske)

1. juli 2022

Datoer for studieregistrering

Først indsendt

14. april 2015

Først indsendt, der opfyldte QC-kriterier

14. april 2015

Først opslået (Skøn)

17. april 2015

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

25. juli 2022

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

21. juli 2022

Sidst verificeret

1. juli 2022

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • CASE3815

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