Imaging Guided Breast BiopsyIBESTNCT01811043
Improving Biopsy Experiences Study for Women
A study testing Guided Meditation, Music and Supportive Dialogue in people with Imaging Guided Breast Biopsy, run by Duke University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 years and older, women only
- Conditions the study is for
- Imaging Guided Breast Biopsy
- What is being tested?
- Guided Meditation, Music and Supportive Dialogue
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 243 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2012to Feb 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- significant hearing impairment
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- Guided Meditation, Music, Supportive Dialogue
- Keywords
- breast biopsy, anxiety
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Guided MeditationBehavioural
MusicBehavioural
Supportive DialogueBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Guided Meditation | Experimental | Guided meditation is played via headphones during biopsy Receives: Behavioral: Guided Meditation |
| Music | Active comparator | Music is played via headphones during biopsy Receives: Behavioral: Music |
| Supportive Dialogue | Placebo comparator | Supportive dialogue is provided during biopsy by the radiologist performing the procedure Receives: Behavioral: Supportive Dialogue |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: 60 months following biopsy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2013 (estimated)
- Study startAug 2012
- Primary completionFeb 2017
- Study completionFeb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Imaging Guided Breast BiopsyStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 243 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mary Scott Soo, MD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01811043
- Sponsor's protocol ID
- Pro00038873
- Acronym
- IBEST
- Status last verified
- Nov 2017
- First submitted
- 11 Mar 2013
- Last updated
- 27 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Biopsy Experiences Study for Women
- ClinicalTrials.gov ID
- NCT01811043
- Acronym / sponsor ID
- IBEST / Pro00038873
- Conditions
- Imaging Guided Breast Biopsy
- Keywords
- breast biopsy, anxiety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 243 participants (estimated)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- Aug 2012
- Primary completion
- Feb 2017 (actual)
- Study completion
- Feb 2017 (actual)
- First posted
- 14 Mar 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Guided Meditation | Experimental | Behavioral: Guided MeditationGuided meditation is played via headphones during biopsy |
| Music | Active comparator | Behavioral: MusicMusic is played via headphones during biopsy |
| Supportive Dialogue | Placebo comparator | Behavioral: Supportive DialogueSupportive dialogue is provided during biopsy by the radiologist performing the procedure |
Who may qualify
- Ages
- 21 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (1 listed)
- significant hearing impairment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Guided Meditation | Behavioural | Guided Meditation |
| Music | Behavioural | Music |
| Supportive Dialogue | Behavioural | Supportive Dialogue |
Primary outcome
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.
1 secondary outcome
Rates of adherence to recommended follow-up care
Time frame: 60 months following biopsy
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mary Scott Soo, MD principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Guided Meditation, Music and Supportive Dialogue in people with Imaging Guided Breast Biopsy, run by Duke University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2023.