The Biopsychosocial Burden of Prostate Biopsy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

47 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-01-31

Study Completion Date

2016-10-31

Brief Summary

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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.

Detailed Description

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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%.

Conditions

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Prostate Cancer

Keywords

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Prostate cancer Biopsy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Questionnaire

Interview

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* prostate cancer suspicion (PSA \> 4 ng / dL, digital rectal examination)

Exclusion Criteria

* not agree to participate

Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Responsible Party

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Leonardo Oliveira Reis

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Hospital das Clínicas Unicamp

Campinas, São Paulo, Brazil

Site Status

Countries

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Brazil

References

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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.

Reference Type BACKGROUND

PMID: 20937009 (View on PubMed)

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.

Reference Type DERIVED

PMID: 31057971 (View on PubMed)

Other Identifiers

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Prostate Biopsy Burden

Identifier Type: -

Identifier Source: org_study_id