- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT03387527
Using Decision Analysis to Enhance Decision-Making Regarding Prostate Cancer Screening
The purpose of this study is to evaluate a new counseling tool for patients deciding whether or not to undergo prostate cancer screening. This screening decision aid is a computer program that provides individual patients estimates of their risks of prostate cancer diagnosis, prostate cancer related death, or death from any cause. The researchers are evaluating whether or not patients find this screening decision aid helpful. As part of this study, participants will be asked for their response on questionnaires.
If patients find the screening decision aid helpful, the researchers will make it available at other clinic locations.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
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Ohio
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Cleveland, Ohio, Forente stater, 44195
- Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- Life expectancy > 10 years
- Ability to read English
Exclusion Criteria:
- Personal history of prostate cancer
- Personal history of prostate biopsy or prostate surgery
- Prior prostate specific antigen screening in the past year leading up to their scheduled clinic visit
- Cognitive impairment
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Støttende omsorg
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Eksperimentell: Prostate Cancer Decision Aid
The research intervention will be exposure to the screening decision aid.
Patients will receive standardized counseling including population based risks and benefits of prostate cancer screening.
Then, patients will be given opportunity to review the screening decision aid prior to offering a decision on whether or not to undergo prostate cancer screening.
The patient decision aid will be a computer application that generates predicted risks associated with prostate cancer.
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Patients will undergo standardized counseling and individualized counseling with the screening decision aid.
The screening decision aid is a computer program that provides individual patients estimates of their risks of prostate cancer diagnosis, prostate cancer related death, or death from any cause
Andre navn:
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Number of initial interviews completed in 60 minutes
Tidsramme: 60 minutes from beginning of interview
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To be considered feasible in a busy clinical setting, researchers anticipate 80% of the initial interviews to be completed within the allotted 60-minute interview time.
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60 minutes from beginning of interview
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Health Literacy
Tidsramme: 1 month after clinical visit
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Five item scale measuring attitudes towards screening
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1 month after clinical visit
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Patient decisional control preferences
Tidsramme: 1 month after clinical visit
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4 item scale where lower scores indicate more positive outcomes from screening
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1 month after clinical visit
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Decisional conflict Scale
Tidsramme: 1 month after clinical visit
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16 item scale ranging in a score from 0-4 where higher scores indicate more disagreement
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1 month after clinical visit
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Multidimensional measure of informed choice
Tidsramme: 1 month after clinical visit
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10 item true/false scale
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1 month after clinical visit
|
Decisional regret scale
Tidsramme: 1 month after clinical visit
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5 item questionnaire using 5 point Likert scales where higher scores indicate more disagreement
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1 month after clinical visit
|
Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Hovedetterforsker: Michael A Brooks, MD, Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- CASE7817
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
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