The Biopsychosocial Burden of Prostate Biopsy
20. december 2018 opdateret af: Leonardo Oliveira Reis, University of Campinas, Brazil
The Biopsychosocial Burden of Prostate Biopsy at the Time of Its Indication, Procedure, and Pathological Report
Prostate biopsy was offered to 47 consecutive patients with prostate-specific antigen (PSA) over 4 ng/dl or suspicious digital rectal examination (DRE) of whom 16 had undergone a biopsy.
Comprehensive validated questionnaires at TIME 0 (pre-biopsy), TIME 1 (before diagnosis, 20 days after biopsy) and TIME 2 (after diagnosis, 40 days after biopsy) accessed patients' erectile (IIEF-5) and voiding (IPSS) functions, Beck scales measured anxiety (BAI), hopelessness (BHS) and depression (BDI), added to the emotional thermometers including five visual analog scales for distress, anxiety, depression, anger and need for help.
Mann-Whitney or Friedman tests were obtained among times and studied variables.
Studieoversigt
Detaljeret beskrivelse
A prospective, longitudinal and observational study in which the sexually active patients were evaluated in the Urology Department of the city of Paulínia, submitted to biopsy guided by transrectal ultrasound after ethics committee approval (355.357).
Consecutive patients who were attended by urologist and present prostate cancer suspicions (PSA> 4 ng / dL and/or rectal examination (TR) were submitted a BXP. They were evaluated at three different moments of the biopsy:
- Seven days before the biopsy procedure (T0);
- 20 days after the biopsy, upon receiving the histopathological result, before becoming aware of it (T1);
- 40 days after the biopsy, 20 days after being aware of the test result (T2). Sixty-one consecutive patients were invited to participate in the study, 10 of them had no active sexual life and 9 answered the questionnaires only at the first moment, were excluded; 47 responded at three times (T0, T1, and T2).
Validated instruments were applied - IIEF-5 (erectile function); - IPSS (voiding function); - Beck scales - BAI (anxiety), BHS (hopelessness), BDI (depression); and - Emotional thermometers.
The comparison among the moments (T0, T1, and T2) was performed through Friedman (analysis of variance) for repeated measures with the variables transformed in stations. The comparison between patients and variables was performed using the Mann-Whitney test. The sample power was calculated and the level of significance considered was 5%.
Undersøgelsestype
Observationel
Tilmelding (Faktiske)
47
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
SP
-
Campinas, SP, Brasilien, 13083-887
- Hospital das Clínicas Unicamp
-
-
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
18 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
N/A
Køn, der er berettiget til at studere
Han
Prøveudtagningsmetode
Sandsynlighedsprøve
Studiebefolkning
Consecutive patients who were attended by a urologist with prostate biopsy indication.
Beskrivelse
Inclusion Criteria:
- prostate cancer suspicion (PSA > 4 ng / dL, digital rectal examination)
Exclusion Criteria:
- not agree to participate
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Erectile Function
Tidsramme: Change from time of biopsy indication (T0) compared to 20 days after procedure (T1) and 20 days after pathological report result (T2, 40 days)
|
International Index of Erectile Function - IIEF-5 index (range 0-25; higher better)
|
Change from time of biopsy indication (T0) compared to 20 days after procedure (T1) and 20 days after pathological report result (T2, 40 days)
|
|
Voiding Function
Tidsramme: Change from time of biopsy indication (T0) compared to 20 days after procedure (T1) and 20 days after pathological report result (T2, 40 days)
|
International Prostatic Symptoms Score - IPSS (range 0-35; higher worse)
|
Change from time of biopsy indication (T0) compared to 20 days after procedure (T1) and 20 days after pathological report result (T2, 40 days)
|
|
Beck scale
Tidsramme: Change from time of biopsy indication (T0) compared to 20 days after procedure (T1) and 20 days after pathological report result (T2, 40 days)
|
Beck Anxiety Index - BAI (0-63; higher worse)
|
Change from time of biopsy indication (T0) compared to 20 days after procedure (T1) and 20 days after pathological report result (T2, 40 days)
|
|
Emotional thermometers
Tidsramme: Change from time of biopsy indication (T0) compared to 20 days after procedure (T1) and 20 days after pathological report result (T2, 40 days)
|
Thermometer score (range 0-10; higher worse)
|
Change from time of biopsy indication (T0) compared to 20 days after procedure (T1) and 20 days after pathological report result (T2, 40 days)
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
- Naccarato AM, Reis LO, Matheus WE, Ferreira U, Denardi F. Barriers to prostate cancer screening: psychological aspects and descriptive variables---is there a correlation? Aging Male. 2011 Mar;14(1):66-71. doi: 10.3109/13685538.2010.522277. Epub 2010 Oct 12.
- Laranja WW, Sanches BCF, Voris BRI, Alonso JCC, Simoes FA, Rejowski RF, Reis LO. The Biopsychosocial Burden of Prostate Biopsy at the Time of Its Indication, Procedure, and Pathological Report. Prostate Cancer. 2019 Apr 1;2019:2653708. doi: 10.1155/2019/2653708. eCollection 2019.
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. januar 2014
Primær færdiggørelse (Faktiske)
1. januar 2015
Studieafslutning (Faktiske)
1. oktober 2016
Datoer for studieregistrering
Først indsendt
17. december 2018
Først indsendt, der opfyldte QC-kriterier
18. december 2018
Først opslået (Faktiske)
21. december 2018
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
24. december 2018
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
20. december 2018
Sidst verificeret
1. december 2018
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- Prostate Biopsy Burden
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
UBESLUTET
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Ingen
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ingen
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .