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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 oppdatert av: 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.

Studieoversikt

Status

Avsluttet

Forhold

Intervensjon / Behandling

Detaljert 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.

Studietype

Intervensjonell

Registrering (Faktiske)

319

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Forente stater
    • Ohio
      • Cleveland, Ohio, Forente stater, 44106-5065
        • Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

19 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Ja

Kjønn som er kvalifisert for studier

Mann

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Screening
  • Tildeling: Ikke-randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

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

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Case Comprehensive Cancer Center

Etterforskere

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

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

1. juni 2015

Primær fullføring (Faktiske)

1. oktober 2021

Studiet fullført (Faktiske)

1. juli 2022

Datoer for studieregistrering

Først innsendt

14. april 2015

Først innsendt som oppfylte QC-kriteriene

14. april 2015

Først lagt ut (Anslag)

17. april 2015

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

25. juli 2022

Siste oppdatering sendt inn som oppfylte QC-kriteriene

21. juli 2022

Sist bekreftet

1. juli 2022

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • CASE3815

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Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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