Improving Biopsy Experiences Study for Women

NCT ID: NCT01811043

Last Updated: 2023-10-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

243 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-08-31

Study Completion Date

2017-02-28

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Imaging Guided Breast Biopsy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Guided Meditation

Guided meditation is played via headphones during biopsy

Group Type EXPERIMENTAL

Guided Meditation

Intervention Type BEHAVIORAL

Music

Music is played via headphones during biopsy

Group Type ACTIVE_COMPARATOR

Music

Intervention Type BEHAVIORAL

Supportive Dialogue

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

Group Type PLACEBO_COMPARATOR

Supportive Dialogue

Intervention Type BEHAVIORAL

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Guided Meditation

Intervention Type BEHAVIORAL

Music

Intervention Type BEHAVIORAL

Supportive Dialogue

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

21 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Duke University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Mary Scott Soo, MD

Role: PRINCIPAL_INVESTIGATOR

Duke University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Duke Cancer Institute

Durham, North Carolina, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

Pro00038873

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

The Preoperative Health & Body Study
NCT01516190 ACTIVE_NOT_RECRUITING NA
RCT of CBD for Anxiety in Advanced Breast Cancer
NCT04482244 ACTIVE_NOT_RECRUITING PHASE2