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

NCT02796612 | Completed DMC

• 1 other identifier: EK261/12
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 3

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).

Conditions

Anxiety

Keywords

anxiety; breast cancer, suspected; breast biopsy; empathy; standardized and structured information; anxiety reduction

Outcome Measures

Primary Outcomes (1)

• Reduction of level of anxiety compared between arm 'no intervention' and arm 'intervention' as measured via questionnaires

  up to 19 months

Secondary Outcomes (6)

• level of anxiety in the intervention group during and after biopsy measured via questionnaires

  up to 19 months

• correlation of the level of anxiety and the histological diagnosis of breast cancer measured via questionnaires

  up to 19 months

• perception of pain during and after biopsy measured via pain score

  up to 19 months

• influence of waiting time between biopsy and histological diagnosis on the level of anxiety measured via questionnaires

  up to 19 months

• correlation of patient's perception of pain and anxiety and physician's impression of patient's perception measured by questionnaires

  up to 19 months

Study Arms (2)

No intervention

ACTIVE COMPARATOR

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

Other: no intervention

Intervention group

EXPERIMENTAL

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; Behavioral: delivery of a take-home brochure; Behavioral: patient care by a psychologically trained physician

Interventions

no intervention OTHER

Patients do not receive any interventions but are treated according to current standard of care.

Intervention group; No intervention

delivery of a take-home brochure BEHAVIORAL

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.

Intervention group

patient care by a psychologically trained physician BEHAVIORAL

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.

Intervention group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Basel, Switzerland: lead

Study Sites (3)

University Hospital of Basel

Basel, Canton of Basel-City, 4031, Switzerland

Location

Claraspital

Basel, Canton of Basel-City, Switzerland

Location

GZO Wetzikon

Wetzikon, Canton of Zurich, Switzerland

Location

Related Publications (1)

• Machacek M, Urech C, Tschudin S, Werlen L, Schoenenberger CA, Zanetti-Dallenbach R. Impact of a brochure and empathetic physician communication on patients' perception of breast biopsies. Arch Gynecol Obstet. 2023 Nov;308(5):1611-1620. doi: 10.1007/s00404-023-07058-w. Epub 2023 May 20.

  PMID: 37209201 DERIVED

MeSH Terms

Conditions

Anxiety Disorders; Breast Neoplasms

Condition Hierarchy (Ancestors)

Mental Disorders; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Rosanna Zanetti, PD Dr. MD

  Claraspital Basel

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 17, 2015
• First Posted: June 13, 2016
• Study Start: April 1, 2014
• Primary Completion: October 5, 2018
• Study Completion: October 5, 2018
• Last Updated: November 13, 2018

Record last verified: 2018-11

Locations

CH (3)