Improving Biopsy Experiences Study for Women

Study Overview
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Brief Summary
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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.

Official Title
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Improving Biopsy Experiences Study for Women

Conditions
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Imaging Guided Breast Biopsy

Intervention / Treatment
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* Behavioral: Guided Meditation
* Behavioral: Music
* Behavioral: Supportive Dialogue


Participation Criteria
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Eligibility Criteria
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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 Exclusion Criteria: significant hearing impairment

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Guided Meditation<br>Guided meditation is played via headphones during biopsy | Behavioral: Guided Meditation<br> <br> |
| Active Comparator: Music<br>Music is played via headphones during biopsy | Behavioral: Music<br> <br> |
| Placebo Comparator: Supportive Dialogue<br>Supportive dialogue is provided during biopsy by the radiologist performing the procedure | Behavioral: Supportive Dialogue<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Anxiety | 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. | 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. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rates of adherence to recommended follow-up care | 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. | 60 months following biopsy | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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breast biopsy, anxiety