The Biopsychosocial Burden of Prostate Biopsy
The Biopsychosocial Burden of Prostate Biopsy at the Time of Its Indication, Procedure, and Pathological Report
調査の概要
詳細な説明
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%.
研究の種類
入学 (実際)
連絡先と場所
研究場所
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SP
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Campinas、SP、ブラジル、13083-887
- Hospital das Clínicas Unicamp
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
説明
Inclusion Criteria:
- prostate cancer suspicion (PSA > 4 ng / dL, digital rectal examination)
Exclusion Criteria:
- not agree to participate
研究計画
研究はどのように設計されていますか?
デザインの詳細
この研究は何を測定していますか?
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Erectile Function
時間枠:Change from time of biopsy indication (T0) compared to 20 days after procedure (T1) and 20 days after pathological report result (T2, 40 days)
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International Index of Erectile Function - IIEF-5 index (range 0-25; higher better)
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Change from time of biopsy indication (T0) compared to 20 days after procedure (T1) and 20 days after pathological report result (T2, 40 days)
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Voiding Function
時間枠:Change from time of biopsy indication (T0) compared to 20 days after procedure (T1) and 20 days after pathological report result (T2, 40 days)
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International Prostatic Symptoms Score - IPSS (range 0-35; higher worse)
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Change from time of biopsy indication (T0) compared to 20 days after procedure (T1) and 20 days after pathological report result (T2, 40 days)
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Beck scale
時間枠:Change from time of biopsy indication (T0) compared to 20 days after procedure (T1) and 20 days after pathological report result (T2, 40 days)
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Beck Anxiety Index - BAI (0-63; higher worse)
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Change from time of biopsy indication (T0) compared to 20 days after procedure (T1) and 20 days after pathological report result (T2, 40 days)
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Emotional thermometers
時間枠:Change from time of biopsy indication (T0) compared to 20 days after procedure (T1) and 20 days after pathological report result (T2, 40 days)
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Thermometer score (range 0-10; higher worse)
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Change from time of biopsy indication (T0) compared to 20 days after procedure (T1) and 20 days after pathological report result (T2, 40 days)
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協力者と研究者
出版物と役立つリンク
一般刊行物
- 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.
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
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