Improving Biopsy Experiences Study for Women

Not Applicable

Completed

• Conditions: Imaging Guided Breast Biopsy
• Interventions: Behavioral: Supportive Dialogue; Behavioral: Guided Meditation; Behavioral: Music

• Registration Number: NCT01811043
• Lead Sponsor: Duke University

Brief Summary

The goal of this study is to examine whether a guided meditation intervention will reduce anxiety and distress as compared to a music intervention or radiologist supportive dialogue in women undergoing imaging-guided core needle breast biopsies. Both the guided meditation and music interventions are administered through use of headphones during routine outpatient imaging-guided core needle breast biopsies. Women in the guided meditation and music conditions will be given a CD with instructions for home practice. Women complete follow-up questionnaires in the 12 months after biopsy. Receipt of recommended follow-up care is examined for 60 months.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-08
• Study First Submitted: 2013-03-11
• Study First Submitted QC: 2013-03-12
• Study First Posted: 2013-03-14
• Primary Completion: 2017-02
• Study Completion: 2017-02
• Status Verified: 2017-11
• Last Update Submitted: 2023-10-26
• Last Update Posted: 2023-10-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 243

Inclusion Criteria

• 21 years old or older
• Undergoing imaging guided core needle biopsy
• Mammography or ultrasound Breast Imaging - Reporting and Data System(BI-RADS) final assessment category 3,4a-c, or 5
• Able to speak and read English
• Able to provide meaningful consent

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Exclusion Criteria

• significant hearing impairment

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Supportive Dialogue	Supportive Dialogue	Supportive dialogue is provided during biopsy by the radiologist performing the procedure
Guided Meditation	Guided Meditation	Guided meditation is played via headphones during biopsy
Music	Music	Music is played via headphones during biopsy

Primary Outcome Measures

Name	Time	Method
Change in Anxiety	Change in anxiety from baseline (i.e., pre biopsy) assessment to post biopsy assessment will be examined. Participants will be followed for the duration of the biopsy, with an expected average of 1.5 hours between assessments.	Anxiety is measured using the State Anxiety Scale of the State Trait Anxiety Inventory. Women complete this self-report measure at baseline (i.e., immediately prior to biopsy in the biopsy clinic) and immediately post-biopsy. Change in anxiety will be measured as change from baseline to post biopsy (i.e., post biopsy anxiety - baseline anxiety.) The expected duration from baseline to post biopsy assessment is expected to be an average of 1.5 hours.

Secondary Outcome Measures

Name	Time	Method
Rates of adherence to recommended follow-up care	60 months following biopsy	Adherence to recommended mammography and clinical breast exam will be assessed for 60 months following biopsy. Adherence (i.e., repeated on schedule mammograms; repeated on schedule clinical breast exams) at 60 months post biopsy will be compared across study arms.

Trial Locations

Locations (1)

Duke Cancer Institute; 🇺🇸 Durham, North Carolina, United States