Trial document





This trial has been registered retrospectively.
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  DRKS00022361

Trial Description

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Title

Prospective randomized analysis of psychological distress in men before, during, and after MR-fusion prostate biopsy depending on preoperative guidance

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

Patients complete questionnaires assessing psychological harms and distress before, during, and after MR-fusion prostate biopsy.

Men attending the Department of Urology and the Department of Diagnostic and Interventional Radiology of the University Hospital Bonn for transrectal MR-fusion prostate biopsy will be provided with additional instructions and information concerning the MR-fusion biopsy procedure after MR-Imaging.
Thereby, patients are randomized in two groups: One group will be informed with a factual leaflet free of emotional influences stating the likelihood of the presence of prostate cancer based on the PI-RADS assessment. The second group will be informed by a more sensitive and empathic description. Moreover, physical and psychological abilities to cope with anxiety and pain during prostate biopsy are proposed to the patients of this group.
Measurements of anxiety, pain, perceived stress and self-efficacy will take place at certain times: Time 0 (before medical consultation on prostate biopsy), Time 1 (directly before prostate biopsy), Time 2 (directly after prostate biopsy).

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Brief Summary in Scientific Language

Men attending the Department of Urology and the Department of Diagnostic and Interventional Radiology of the University Hospital Bonn for transrectal MR-fusion prostate biopsy will be provided with additional instructions and information concerning the MR-fusion biopsy procedure after MR-Imaging. Thereby, patients are randomized in two groups: One group will be informed with a factual leaflet free of emotional influences; the second group will be informed by a more sensitive and empathic description. Randomization will be done by a simple prescribed randomization list.

Patients will be asked to complete self-reported standardized questionnaires on perceived stress (Perceived Stress Scale (PSS)), general self-efficacy (General Self Efficacy Scale (GSES), pain (Brief Pain Inventory (BPI)) and anxiety (State Trait Anxiety Inventory (STAI)). Moreover, self-created questionnaires on expected and experienced pain during MR-fusion prostate biopsy and on the impact of the additional information given by the leaflet, will be used at certain times.
Measurements take place at the following times:
Time 0 (before medical consultation on prostate biopsy):
- PSS
- GSES
- Adapted BPI
- STAI (all 40 items)
- Expected Pain Questionnaire
- T0-Questionnaire regarding the additional information given on MR-fusion biopsy
Time 1 (directly before prostate biopsy):
- Adapted BPI
- STAI (20 items on anxiety state)
- Expected Pain Questionnaire
- T1-Questionnaire regarding the additional information given on MR-fusion biopsy
Time 2 (directly after prostate biopsy)
- Adapted BPI
- STAI (20 items on anxiety state)
- Experienced Pain Questionnaire
- T2-Questionnaire regarding the additional information given on MR-fusion biopsy

Safety: We are not expecting unwanted, harmful events.

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Do you plan to share individual participant data with other researchers?

No

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Description IPD sharing plan:

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Organizational Data

  •   DRKS00022361
  •   2020/10/28
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  •   yes
  •   Approved
  •   307/20, Ethik-Kommission der Medizinischen Fakultät der Rheinischen Friedrich-Wilhelms-Universität Bonn
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Secondary IDs

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Health Condition or Problem studied

  •   C61 -  Malignant neoplasm of prostate
  •   F41.3 -  Other mixed anxiety disorders
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Interventions/Observational Groups

  •   Educational sheet with short and factual language and information content
  •   Information sheet with detailed and sensitive language usage and information content
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Open (masking not used)
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  •   Other
  •   Other
  •   Other
  •   N/A
  •   N/A
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Primary Outcome

Percentage of patients suffering from perioperative mild, moderate and severe pain and anxiety depending on the preoperative given information

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Secondary Outcome

• Percentage of patients with low self efficacy suffering from perioperative mild, moderate and severe pain and anxiety
• Percentage of patients with high perceived stress suffering from perioperative mild, moderate and severe pain and anxiety

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2020/09/20
  •   180
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Male
  •   45   Years
  •   85   Years
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Additional Inclusion Criteria

Subjects will only be included in the study if they meet all of the following criteria:
General inclusion criteria:
• Subjects: male, aged 45-85
• Clinical suspicion of prostate cancer and MR-fusion biopsy recommended to subject.
• Subject is able to follow the study instructions and likely to comply with all necessary study visits (compliance).
• Subject has given written consent to participate in the study.

Indication-specific inclusion criteria: none

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Exclusion Criteria

Subjects will not be included in the study if any of the following criteria applies:
General Exclusion Criteria:
• Subject without legal capacity who is unable to understand the nature, scope, significance and consequences of this clinical trial
•Subjects with a physical or psychiatric condition which at the investigator’s discretion may put the subject at risk, may confound the trial results, or may interfere with the subject’s participation in this clinical trial
• Known or persistent abuse of medication, drugs or alcohol
• Contraindications for magnetic resonance imaging

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Addresses

  • start of 1:1-Block address primary-sponsor
    • Universitätsklinikum Bonn Klinik und Kinderklinik für Urologie
    • Mr.  Dr. med.  Philipp  Krausewitz 
    • Venusberg-Campus 1
    • 53127  Bonn
    • Germany
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    • Universitätsklinikum Bonn Klinik und Kinderklinik für Urologie
    • Mr.  Dr. med.  Philipp  Krausewitz 
    • Venusberg-Campus 1
    • 53127  Bonn
    • Germany
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    • Universitätsklinikum Bonn Klinik und Kinderklinik für Urologie
    • Mr.  Dr. med.  Philipp  Krausewitz 
    • Venusberg-Campus 1
    • 53127  Bonn
    • Germany
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Sources of Monetary or Material Support

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    • Universitätsklinikum Bonn Klinik und Kinderklinik für Urologie
    • Mr.  Dr. med.  Philipp  Krausewitz 
    • Venusberg-Campus 1
    • 53127  Bonn
    • Germany
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.