Improving Biopsy Experiences Study for Women

NCT01811043 | Completed

• 1 other identifier: Pro00038873
• Study Type: interventional
• Target: 243
• Locations: 1 country
• Sites: 1

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.

Conditions

Imaging Guided Breast Biopsy

Keywords

breast biopsy; anxiety

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Rates of adherence to recommended follow-up care

  60 months following biopsy

Study Arms (3)

Guided Meditation

EXPERIMENTAL

Guided meditation is played via headphones during biopsy

Behavioral: Guided Meditation

Music

ACTIVE COMPARATOR

Music is played via headphones during biopsy

Behavioral: Music

Supportive Dialogue

PLACEBO COMPARATOR

Supportive dialogue is provided during biopsy by the radiologist performing the procedure

Behavioral: Supportive Dialogue

Interventions

Guided Meditation BEHAVIORAL

Guided Meditation

Music BEHAVIORAL

Music

Supportive Dialogue BEHAVIORAL

Supportive Dialogue

Eligibility Criteria

• Age: 21 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• significant hearing impairment

Sponsors & Collaborators

• Duke University: lead

Study Sites (1)

Duke Cancer Institute

Durham, North Carolina, 27710, United States

Location

MeSH Terms

Conditions

Anxiety Disorders

Interventions

Music Therapy

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

Sensory Art Therapies; Complementary Therapies; Therapeutics; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Mary Scott Soo, MD

  Duke University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 11, 2013
• First Posted: March 14, 2013
• Study Start: August 1, 2012
• Primary Completion: February 1, 2017
• Study Completion: February 1, 2017
• Last Updated: October 27, 2023

Record last verified: 2017-11

Locations

US (1)