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Improving Biopsy Experiences Study for Women (IBEST)

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ClinicalTrials.gov Identifier: NCT01811043
Recruitment Status : Completed
First Posted : March 14, 2013
Last Update Posted : December 5, 2017
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Imaging Guided Breast Biopsy Behavioral: Guided Meditation Behavioral: Music Behavioral: Supportive Dialogue Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 243 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Improving Biopsy Experiences Study for Women
Study Start Date : August 2012
Actual Primary Completion Date : February 2017
Actual Study Completion Date : February 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety Biopsy

Arm Intervention/treatment
Experimental: Guided Meditation
Guided meditation is played via headphones during biopsy
Behavioral: Guided Meditation
Active Comparator: Music
Music is played via headphones during biopsy
Behavioral: Music
Placebo Comparator: Supportive Dialogue
Supportive dialogue is provided during biopsy by the radiologist performing the procedure
Behavioral: Supportive Dialogue



Primary Outcome Measures :
  1. Change in Anxiety [ Time Frame: 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 :
  1. Rates of adherence to recommended follow-up care [ Time Frame: 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

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): NCT01811043


Locations
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United States, North Carolina
Duke Cancer Institute
Durham, North Carolina, United States, 27710
Sponsors and Collaborators
Duke University
Investigators
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Principal Investigator: Mary Scott Soo, MD Duke University

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Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT01811043     History of Changes
Other Study ID Numbers: Pro00038873
First Posted: March 14, 2013    Key Record Dates
Last Update Posted: December 5, 2017
Last Verified: November 2017
Keywords provided by Duke University:
breast biopsy
anxiety