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Empathy and Standard Diagnostic Procedures in an Outpatient Breast Clinic Might Not be Enough

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ClinicalTrials.gov Identifier: NCT02796612
Recruitment Status : Completed
First Posted : June 13, 2016
Last Update Posted : November 12, 2018
Sponsor:
Information provided by (Responsible Party):
University Hospital, Basel, Switzerland

Brief Summary:
The project investigates prospectively whether anxiety in the context of breast biopsy can be reduced by the planed intervention (take-home brochure and structured and standardized information given by a psychologically trained physician who performs the biopsy).

Condition or disease Intervention/treatment Phase
Anxiety Other: no intervention Behavioral: delivery of a take-home brochure Behavioral: patient care by a psychologically trained physician Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 250 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Empathy and Standard Diagnostic Procedures in an Outpatient Breast Clinic Might Not be Enough
Actual Study Start Date : April 2014
Actual Primary Completion Date : October 5, 2018
Actual Study Completion Date : October 5, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

Arm Intervention/treatment
Active Comparator: No intervention
Patients receive the current standard of care and are asked to answer the questionnaires mentioned below.
Other: no intervention
Patients do not receive any interventions but are treated according to current standard of care.

Experimental: Intervention group

Patients receive the current standard of care and are asked to answer the questionnaires mentioned below.

Additionally, delivery of a take-home brochure to the patients during the first visit is planned. The biopsy is explained to the patient and performed by a psychological trained physician. Patient care by a psychologically trained physician is performed in the sense that patients are informed about their biopsy result by a specifically trained physician.

Other: no intervention
Patients do not receive any interventions but are treated according to current standard of care.

Behavioral: delivery of a take-home brochure
Content of brochure is dealing with symptoms, as well as mammographic and ultrasound findings, which need further investigation, will be addressed. The procedure of the breast biopsy itself will be explained in detail. The time in which the histological diagnosis can be expected will be indicated and follow up in case of a benign histology and the necessary therapy in case of breast cancer will be addressed.

Behavioral: patient care by a psychologically trained physician
The physicians who perform the biopsies will be instructed by means of a psychological training how to give structured and standardized information in order not only to inform comprehensively, but also to meet the patients' emotional needs.




Primary Outcome Measures :
  1. Reduction of level of anxiety compared between arm 'no intervention' and arm 'intervention' as measured via questionnaires [ Time Frame: up to 19 months ]

Secondary Outcome Measures :
  1. level of anxiety in the intervention group during and after biopsy measured via questionnaires [ Time Frame: up to 19 months ]
  2. correlation of the level of anxiety and the histological diagnosis of breast cancer measured via questionnaires [ Time Frame: up to 19 months ]
  3. perception of pain during and after biopsy measured via pain score [ Time Frame: up to 19 months ]
  4. influence of waiting time between biopsy and histological diagnosis on the level of anxiety measured via questionnaires [ Time Frame: up to 19 months ]
  5. correlation of patient's perception of pain and anxiety and physician's impression of patient's perception measured by questionnaires [ Time Frame: up to 19 months ]
  6. patient's satisfaction with additional information concerning biopsy measured by Visual Analog Scale [ Time Frame: up to 19 months ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • women who speak and understand German
  • women who will need a skin biopsy, core biopsy or a vacuum assisted biopsy.

Exclusion Criteria:

  • women receiving a fine needle Aspiration
  • women receiving an examination of a pathologic nipple secretion
  • women receiving an abscess evacuation
  • women who do not speak and understand German

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02796612


Locations
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Switzerland
University Hospital of Basel
Basel, Basel-Stadt, Switzerland, 4031
Claraspital
Basel, Basel-Stadt, Switzerland
GZO Wetzikon
Wetzikon, Zürich, Switzerland
Sponsors and Collaborators
University Hospital, Basel, Switzerland
Investigators
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Principal Investigator: Rosanna Zanetti, PD Dr. MD Claraspital Basel

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Responsible Party: University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier: NCT02796612     History of Changes
Other Study ID Numbers: EK261/12
First Posted: June 13, 2016    Key Record Dates
Last Update Posted: November 12, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by University Hospital, Basel, Switzerland:
anxiety
breast cancer, suspected
breast biopsy
empathy
standardized and structured information
anxiety reduction