Breast CancerCALMNCT03877146
Calming Alternatives Learned During MRI-Guided Breast Biopsy
A study of Breast Cancer and Breast Pain, run by Duke University at 1 site in United States.
Trial summary
The proposed randomized study evaluates whether a controlled breathing intervention could be efficacious for reducing pain in the MRI-guided breast biopsy setting. Support for this intervention stems from experimental and clinical studies on the effects of controlled breathing on pain. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer, Breast Pain, Pain, Acute
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Oct 2018to 20 Jun 2019
- 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women undergoing MRI-guided core needle breast biopsy at the Duke Cancer Institute
- Ability to speak and read in English
- Age ≥ 18 years
- Ability to provide meaningful consent
Who cannot join
- Hearing impairment that is documented in the medical record that would limit the use of the guided intervention or music
- Cognitive impairment that is documented in the medical record or results in being unable to provide meaningful consent
- Undergoing IV-administered sedation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Calming Alternatives Learned During MRI-Guided Breast Biopsy (CALM)
The proposed randomized study evaluates whether a controlled breathing intervention could be efficacious for reducing pain in the MRI-guided breast biopsy setting. Support for this intervention stems from experimental and clinical studies on the effects of controlled breathing on pain. Implementing a controlled breathing intervention during MRI-guided breast biopsy has the potential to provide effective pain management in this outpatient setting. The primary study objectives are to assess the feasibility, acceptability, and efficacy of a novel audio-recorded controlled breathing intervention for reducing breast and body pain in women undergoing MRI-guided breast biopsy. The secondary study objectives are to evaluate the effects of controlled breathing on measures of physiological reactivity (i.e., blood pressure and heart rate), pain catastrophizing, and self-efficacy for pain and anxiety.
- Conditions
- Breast Cancer, Breast Pain, Pain, Acute, Anxiety, Coping Skills, Self Efficacy
- Being tested
- Controlled Breathing Intervention
- Keywords
- Controlled Breathing, MRI-Guided Breast Biopsy, Breast Pain, Body Pain, Anticipatory Pain, Anxiety, Coping Skills, Self Efficacy
- Medical subject headings
- Breast Neoplasms, Mastodynia, Acute Pain, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Controlled Breathing InterventionBehavioural
Participants in the controlled breathing intervention will be provided with headphones to listen to the guided intervention audio file. The intervention will guide participants to breathe at a rate of six breaths per minute (approximately 50% of their normal breathing rate).
| Study group | Role | What they receive |
|---|---|---|
| Usual Care Control Condition | No intervention | As part of usual care, participants will be provided with headphones to listen to music during the biopsy procedure. Music options will include instrumental jazz, classical piano, harp and flute, and world music. |
| Controlled Breathing Intervention | Experimental | Participants in the controlled breathing intervention will be provided with headphones to listen to the guided intervention audio file. Over the course of the 25-60-minute procedure, approximately 50% of the intervention will be spent completing controlled breathing. The other 50% of the intervention will be spent listening to music, which is part of usual care. Music options will include instrumental jazz, classical piano, harp and flute, nature sounds, and world music. Receives: Behavioral: Controlled Breathing Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body pain pre-biopsy: Brief Pain Inventory (BPI) Pain Severity Scale
Body pain pre-biopsy will be will be assessed using four questions from the Brief Pain Inventory (BPI) Pain Severity Scale. Women will be asked to rate 1) worst, 2) least, and 3) average body pain during the past week, as well as 4) current body pain on a scale from 0 (no pain) to 10 (pain as bad as it could be). Consistent with BPI scoring, items will be averaged to create a composite score that had a possible range of 0 to 10 with higher scores indicating greater pain.
Measured: Baseline
Breast pain pre-biopsy: Brief Pain Inventory (BPI) Pain Severity Scale
Breast pain pre-biopsy will be will be assessed using four questions from the Brief Pain Inventory (BPI) Pain Severity Scale. Women will be asked to rate 1) worst, 2) least, and 3) average breast pain during the past week, as well as 4) current breast pain on a scale from 0 (no pain) to 10 (pain as bad as it could be). Consistent with BPI scoring, items will be averaged to create a composite score that had a possible range of 0 to 10 with higher scores indicating greater pain.
Measured: Baseline
Body pain after positioning on the MRI table: Numerical rating scale (NRS)
Body pain after positioning on the MRI table for the biopsy procedure will be will be assessed using a verbally-administered numerical rating scale (NRS) that ranges from 0 (no pain) to 10 (pain as bad as it could be) with higher scores indicating greater pain.
Measured: After positioning on the MRI table, within 1 minute
Breast pain after local anesthetic injection: Numerical rating scale (NRS)
Breast pain after each superficial local anesthetic injection during the biopsy procedure will be will be assessed using a verbally-administered numerical rating scale (NRS) that ranges from 0 (no pain) to 10 (pain as bad as it could be) with higher scores indicating greater pain.
Measured: After each superficial local anesthetic injection, within 1 minute
Breast pain after deeper local anesthetic injection: Numerical rating scale (NRS)
Breast pain after each deeper local anesthetic injection during the biopsy procedure will be will be assessed using a verbally-administered numerical rating scale (NRS) that ranges from 0 (no pain) to 10 (pain as bad as it could be) with higher scores indicating greater pain.
Measured: After each deeper local anesthetic injection, within 1 minute
Body pain after introducer insertion: Numerical rating scale (NRS)
Body pain after the last introducer is inserted will be will be assessed using a verbally-administered numerical rating scale (NRS) that ranges from 0 (no pain) to 10 (pain as bad as it could be) with higher scores indicating greater pain.
Measured: After last introducer insertion, within 1 minute
Breast pain after tissue sampling: Numerical rating scale (NRS)
Breast pain after the last tissue sampling at each biopsy site will be will be assessed using a verbally-administered numerical rating scale (NRS) that ranges from 0 (no pain) to 10 (pain as bad as it could be) with higher scores indicating greater pain.
Measured: After last tissue sampling at each biopsy site, within 1 minute
Body pain after introducer sheath removal: Numerical rating scale (NRS)
Body pain after the last introducer sheath is removed will be will be assessed using a verbally-administered numerical rating scale (NRS) that ranges from 0 (no pain) to 10 (pain as bad as it could be) with higher scores indicating greater pain.
Measured: After last introducer sheath removal, within 1 minute
Body pain post-biopsy: Brief Pain Inventory (BPI) Pain Severity Scale
Body pain post-biopsy will be will be assessed using four questions from the Brief Pain Inventory (BPI) Pain Severity Scale. Women will be asked to rate 1) worst, 2) least, and 3) average body pain during the biopsy procedure, as well as 4) current body pain on a scale from 0 (no pain) to 10 (pain as bad as it could be). Consistent with BPI scoring, items will be averaged to create a composite score that had a possible range of 0 to 10 with higher scores indicating greater pain.
Measured: Post-biopsy, within 1 minute
Breast pain post-biopsy: Brief Pain Inventory (BPI) Pain Severity Scale
Breast pain post-biopsy will be will be assessed using four questions from the Brief Pain Inventory (BPI) Pain Severity Scale. Women will be asked to rate 1) worst, 2) least, and 3) average breast pain during the biopsy procedure, as well as 4) current breast pain on a scale from 0 (no pain) to 10 (pain as bad as it could be). Consistent with BPI scoring, items will be averaged to create a composite score that had a possible range of 0 to 10 with higher scores indicating greater pain.
Measured: Post-biopsy, within 1 minute
Body pain 24 hours post-biopsy: Brief Pain Inventory (BPI) Pain Severity Scale
Body pain 24 hours post-biopsy will be will be assessed using four questions from the Brief Pain Inventory (BPI) Pain Severity Scale. Women will be asked to rate 1) worst, 2) least, and 3) average body pain in the 24 hours post-biopsy, as well as 4) current body pain on a scale from 0 (no pain) to 10 (pain as bad as it could be). Consistent with BPI scoring, items will be averaged to create a composite score that had a possible range of 0 to 10 with higher scores indicating greater pain.
Measured: 24 hours post-biopsy
Breast pain 24 hours post-biopsy: Brief Pain Inventory (BPI) Pain Severity Scale
Breast pain 24 hours post-biopsy will be will be assessed using four questions from the Brief Pain Inventory (BPI) Pain Severity Scale. Women will be asked to rate 1) worst, 2) least, and 3) average breast pain in the 24 hours post-biopsy, as well as 4) current breast pain on a scale from 0 (no pain) to 10 (pain as bad as it could be). Consistent with BPI scoring, items will be averaged to create a composite score that had a possible range of 0 to 10 with higher scores indicating greater pain.
Measured: 24 hours post-biopsy
Secondary outcomes (25)
Number of pre-biopsy body pain sites: Body map
To indicate the number of pre-biopsy body pain sites, participants will complete a full body map, indicating the locations of body pain.
Measured: Baseline
Number of pre-biopsy breast pain sites: Breast map
To indicate the number of pre-biopsy breast pain sites, participants will complete a breast map (showing the chest, shoulders, and upper arms), indicating the locations of breast pain.
Measured: Baseline
Anticipated body pain: Anticipatory body pain scale
Prior to biopsy, one question will be asked to assess anticipated body pain (i.e., "How much body pain do you think you will experience during the biopsy today?") on a scale from 0 (no pain) to 10 (pain as bad as it could be) with higher scores indicating greater anticipated pain.
Measured: Baseline
Anticipated breast pain: Anticipatory breast pain scale
Prior to biopsy, one question will be asked to assess anticipated breast pain (i.e., "How much breast pain do you think you will experience during the biopsy today?") on a scale from 0 (no pain) to 10 (pain as bad as it could be) with higher scores indicating greater anticipated pain.
Measured: Baseline
Anxiety pre-biopsy: State Anxiety Scale of the State-Trait Anxiety Inventory (STAI)
The State Anxiety Scale of the State-Trait Anxiety Inventory (STAI) will assess the degree of anxiety pre-biopsy. Participants will rate each of the 20 items on a 5-point Likert scale, ranging from 1 (not at all) through 4 (very much). Items will be summed, creating a total score (possible range: 20-80).
Measured: Baseline
Likelihood of cancer pre-biopsy: Likelihood of cancer scale
Likelihood of cancer will be assessed pre-biopsy using a 1 single-item scale. Participants will be asked to indicate what they were told regarding the likelihood of cancer from their recommending radiologist on a scale from 0 (not applicable - they did not discuss this with me) to 5 (high likelihood of cancer) with higher scores indicating a greater likelihood of cancer.
Measured: Baseline
Pain coping strategies pre-biopsy: Coping Strategies Questionnaire (CSQ)
To assess the use of pain coping strategies pre-biopsy, participants will complete the 14-item Coping Strategies Questionnaire (CSQ). Participants will rate how frequently they use seven pain coping strategies (two items per scale) on a scale ranging from 0 (not at all) to 6 (a lot). Items will be averaged, giving a total score on each scale ranging from 0 to 6 with higher scores indicating greater use of pain coping strategies.
Measured: Baseline
Self-efficacy for pain and anxiety pre-biopsy: Self-efficacy for pain and anxiety scale
To assess self-efficacy for managing pain and anxiety pre-biopsy, participants will complete a 4-item scale. Items will be rated on a 10-point scale from 1 (not certain) to 10 (very certain). Items will be averaged to create a composite score, ranging from 0 to 10 with higher scores indicating greater self-efficacy.
Measured: Baseline
Blood pressure pre-biopsy
Blood pressure (systolic/diastolic) pre-biopsy will be measured using an MRI-compatible blood pressure cuff.
Measured: Baseline
Pulse pre-biopsy
Heart rate pre-biopsy will be measured using an MRI-compatible pulse oximeter.
Measured: Baseline
Blood pressure after positioning on the MRI table
Blood pressure (systolic/diastolic) after positioning on the MRI table will be measured using an MRI-compatible blood pressure cuff.
Measured: After positioning on the MRI table, within 1 minute
Pulse after positioning on the MRI table
Heart rate after positioning on the MRI table will be measured using an MRI-compatible pulse oximeter.
Measured: After positioning on the MRI table, within 1 minute
Blood pressure after introducer insertion
Blood pressure (systolic/diastolic) after the last introducer is inserted will be measured using an MRI-compatible blood pressure cuff.
Measured: After last introducer insertion, within 1 minute
Pulse after after introducer insertion
Heart rate after the last introducer is inserted will be measured using an MRI-compatible pulse oximeter.
Measured: After last introducer insertion, within 1 minute
Blood pressure after introducer sheath removal
Blood pressure (systolic/diastolic) after the last introducer sheath is removed will be measured using an MRI-compatible blood pressure cuff.
Measured: After last introducer sheath removal, within 1 minute
Pulse after introducer sheath removal
Heart rate after the last introducer sheath is removed will be measured using an MRI-compatible pulse oximeter.
Measured: After last introducer sheath removal, within 1 minute
Anxiety post-biopsy: State Anxiety Scale of the State-Trait Anxiety Inventory (STAI)
The State Anxiety Scale of the State-Trait Anxiety Inventory (STAI) will assess the degree of anxiety post-biopsy. Participants will rate each of the 20 items on a 5-point Likert scale, ranging from 1 (not at all) through 4 (very much). Items will be summed, creating a total score (possible range: 20-80).
Measured: Post-biopsy, within 1 hour
Likelihood of cancer post-biopsy: Likelihood of cancer scale
Likelihood of cancer will be assessed post-biopsy using a single-item scale. Participants will be asked to indicate what they were told regarding the likelihood of cancer from the radiologist performing the biopsy on a scale from 0 (not applicable - they did not discuss this with me) to 5 (high likelihood of cancer).
Measured: Post-biopsy, within 1 hour
Distraction from pain during biopsy: Attention to pain scale
Using a 2-item self-report measure, participants will rate 1) the amount of attention they paid to the pain during biopsy and 2) the extent to which they were able to distract themselves from the pain during biopsy on an 11-point scale, ranging from 0 (not at all) to 10 (very much). An ''attention to pain" score (range -10 to +10) will be calculated by subtracting the ability to distract from pain from the amount of attention to pain. The higher the score, the more attention paid to pain.
Measured: Post-biopsy, within 1 hour
Distraction from pain during biopsy: Time spent thinking about pain scale
Participants will also be asked to rate how much time they spent thinking about pain during the biopsy procedure on an 11-point scale, ranging from 0 (none of the time) to 10 (all of the time).
Measured: Post-biopsy, within 1 hour
Relaxation during biopsy: Relaxation numerical rating scale (NRS)
Participants will be asked to indicate how relaxed they were during the biopsy procedure on a scale, ranging from 0 (not relaxed) to 10 (extremely relaxed).
Measured: Post-biopsy, within 1 hour
Relaxation during biopsy: Tension Subscale of the Profile of Mood State Short-Form
Participants will also be provided with a list of six adjectives (i.e., tense, on-edge, uneasy, restless, nervous, and anxious) from the Tension Subscale of the Profile of Mood State Short-Form and be asked to rate each of the adjectives on a 5-point Likert scale, ranging from 0 (not at all) to 4 (extremely).
Measured: Post-biopsy, within 1 hour
Pain coping strategies post-biopsy: Coping Strategies Questionnaire (CSQ)
To assess the use of pain coping strategies during the biopsy procedure, participants will complete the 14-item Coping Strategies Questionnaire (CSQ). Participants will rate how frequently they used seven pain coping strategies (two items per scale) during the procedure on a scale ranging from 0 (not at all) to 6 (a lot). Items will be averaged, giving a total score on each scale ranging from 0 to 6 with higher scores indicating greater use of pain coping strategies.
Measured: Post-biopsy, within 1 hour
Self-efficacy for pain and anxiety during biopsy: Self-efficacy for pain and anxiety scale
To assess self-efficacy for managing pain and anxiety during the biopsy procedure, participants will complete a 4-item scale. Items will be rated on a 10-point scale from 0 (not certain) to 10 (very certain). Items will be averaged to create a composite score, ranging from 0 to 10 with higher scores indicating greater self-efficacy.
Measured: Post-biopsy, within 1 hour
Anxiety 24 hours post-biopsy: State Anxiety Scale of the State-Trait Anxiety Inventory (STAI)
The State Anxiety Scale of the State-Trait Anxiety Inventory (STAI) will assess the degree of anxiety 24 hours post-biopsy. Participants will rate each of the 20 items on a 5-point Likert scale, ranging from 1 (not at all) through 4 (very much). Items will be summed, creating a total score (possible range: 20-80).
Measured: 24 hours post-biopsy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2019
- Study start16 Oct 2018
- Primary completion20 Jun 2019
- Study completion20 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rebecca Shelby, Ph.D., Principal investigator, Duke Psychiatry and Behavioral Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03877146
- Sponsor's protocol ID
- Pro00100029
- Acronym
- CALM
- Status last verified
- Nov 2018
- First submitted
- 26 Feb 2019
- Last updated
- 25 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Calming Alternatives Learned During MRI-Guided Breast Biopsy (CALM)
- ClinicalTrials.gov ID
- NCT03877146
- Acronym / sponsor ID
- CALM / Pro00100029
- Conditions
- Breast Cancer, Breast Pain, Pain, Acute, Anxiety, Coping Skills, Self Efficacy
- Keywords
- Controlled Breathing, MRI-Guided Breast Biopsy, Breast Pain, Body Pain, Anticipatory Pain, Anxiety, Coping Skills, Self Efficacy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- 16 Oct 2018 (actual)
- Primary completion
- 20 Jun 2019 (actual)
- Study completion
- 20 Jun 2019 (actual)
- First posted
- 15 Mar 2019 (actual)
- 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 proposed randomized study evaluates whether a controlled breathing intervention could be efficacious for reducing pain in the MRI-guided breast biopsy setting. Support for this intervention stems from experimental and clinical studies on the effects of controlled breathing on pain. Implementing a controlled breathing intervention during MRI-guided breast biopsy has the potential to provide effective pain management in this outpatient setting. The primary study objectives are to assess the feasibility, acceptability, and efficacy of a novel audio-recorded controlled breathing intervention for reducing breast and body pain in women undergoing MRI-guided breast biopsy. The secondary study objectives are to evaluate the effects of controlled breathing on measures of physiological reactivity (i.e., blood pressure and heart rate), pain catastrophizing, and self-efficacy for pain and anxiety.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual Care Control Condition | No intervention | –As part of usual care, participants will be provided with headphones to listen to music during the biopsy procedure. Music options will include instrumental jazz, classical piano, harp and flute, and world music. |
| Controlled Breathing Intervention | Experimental | Behavioral: Controlled Breathing InterventionParticipants in the controlled breathing intervention will be provided with headphones to listen to the guided intervention audio file. Over the course of the 25-60-minute procedure, approximately 50% of the intervention will be spent completing controlled breathing. The other 50% of the intervention will be spent listening to music, which is part of usual care. Music options will include instrumental jazz, classical piano, harp and flute, nature sounds, and world music. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Women undergoing MRI-guided core needle breast biopsy at the Duke Cancer Institute
- Ability to speak and read in English
- Age ≥ 18 years
- Ability to provide meaningful consent
Key exclusion criteria (3 listed)
- Hearing impairment that is documented in the medical record that would limit the use of the guided intervention or music
- Cognitive impairment that is documented in the medical record or results in being unable to provide meaningful consent
- Undergoing IV-administered sedation
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 |
|---|---|---|
| Controlled Breathing InterventionParticipants in the controlled breathing intervention will be provided with headphones to listen to the guided intervention audio file. The intervention will guide participants to breathe at a rate of six breaths per minute (approximately 50% of their normal breathing rate). | Behavioural | Controlled Breathing Intervention |
Primary outcome
Body pain pre-biopsy: Brief Pain Inventory (BPI) Pain Severity Scale
Time frame: Baseline
Body pain pre-biopsy will be will be assessed using four questions from the Brief Pain Inventory (BPI) Pain Severity Scale. Women will be asked to rate 1) worst, 2) least, and 3) average body pain during the past week, as well as 4) current body pain on a scale from 0 (no pain) to 10 (pain as bad as it could be). Consistent with BPI scoring, items will be averaged to create a composite score that had a possible range of 0 to 10 with higher scores indicating greater pain.
Breast pain pre-biopsy: Brief Pain Inventory (BPI) Pain Severity Scale
Time frame: Baseline
Breast pain pre-biopsy will be will be assessed using four questions from the Brief Pain Inventory (BPI) Pain Severity Scale. Women will be asked to rate 1) worst, 2) least, and 3) average breast pain during the past week, as well as 4) current breast pain on a scale from 0 (no pain) to 10 (pain as bad as it could be). Consistent with BPI scoring, items will be averaged to create a composite score that had a possible range of 0 to 10 with higher scores indicating greater pain.
Body pain after positioning on the MRI table: Numerical rating scale (NRS)
Time frame: After positioning on the MRI table, within 1 minute
Body pain after positioning on the MRI table for the biopsy procedure will be will be assessed using a verbally-administered numerical rating scale (NRS) that ranges from 0 (no pain) to 10 (pain as bad as it could be) with higher scores indicating greater pain.
Breast pain after local anesthetic injection: Numerical rating scale (NRS)
Time frame: After each superficial local anesthetic injection, within 1 minute
Breast pain after each superficial local anesthetic injection during the biopsy procedure will be will be assessed using a verbally-administered numerical rating scale (NRS) that ranges from 0 (no pain) to 10 (pain as bad as it could be) with higher scores indicating greater pain.
Breast pain after deeper local anesthetic injection: Numerical rating scale (NRS)
Time frame: After each deeper local anesthetic injection, within 1 minute
Breast pain after each deeper local anesthetic injection during the biopsy procedure will be will be assessed using a verbally-administered numerical rating scale (NRS) that ranges from 0 (no pain) to 10 (pain as bad as it could be) with higher scores indicating greater pain.
Body pain after introducer insertion: Numerical rating scale (NRS)
Time frame: After last introducer insertion, within 1 minute
Body pain after the last introducer is inserted will be will be assessed using a verbally-administered numerical rating scale (NRS) that ranges from 0 (no pain) to 10 (pain as bad as it could be) with higher scores indicating greater pain.
Breast pain after tissue sampling: Numerical rating scale (NRS)
Time frame: After last tissue sampling at each biopsy site, within 1 minute
Breast pain after the last tissue sampling at each biopsy site will be will be assessed using a verbally-administered numerical rating scale (NRS) that ranges from 0 (no pain) to 10 (pain as bad as it could be) with higher scores indicating greater pain.
Body pain after introducer sheath removal: Numerical rating scale (NRS)
Time frame: After last introducer sheath removal, within 1 minute
Body pain after the last introducer sheath is removed will be will be assessed using a verbally-administered numerical rating scale (NRS) that ranges from 0 (no pain) to 10 (pain as bad as it could be) with higher scores indicating greater pain.
Body pain post-biopsy: Brief Pain Inventory (BPI) Pain Severity Scale
Time frame: Post-biopsy, within 1 minute
Body pain post-biopsy will be will be assessed using four questions from the Brief Pain Inventory (BPI) Pain Severity Scale. Women will be asked to rate 1) worst, 2) least, and 3) average body pain during the biopsy procedure, as well as 4) current body pain on a scale from 0 (no pain) to 10 (pain as bad as it could be). Consistent with BPI scoring, items will be averaged to create a composite score that had a possible range of 0 to 10 with higher scores indicating greater pain.
Breast pain post-biopsy: Brief Pain Inventory (BPI) Pain Severity Scale
Time frame: Post-biopsy, within 1 minute
Breast pain post-biopsy will be will be assessed using four questions from the Brief Pain Inventory (BPI) Pain Severity Scale. Women will be asked to rate 1) worst, 2) least, and 3) average breast pain during the biopsy procedure, as well as 4) current breast pain on a scale from 0 (no pain) to 10 (pain as bad as it could be). Consistent with BPI scoring, items will be averaged to create a composite score that had a possible range of 0 to 10 with higher scores indicating greater pain.
Body pain 24 hours post-biopsy: Brief Pain Inventory (BPI) Pain Severity Scale
Time frame: 24 hours post-biopsy
Body pain 24 hours post-biopsy will be will be assessed using four questions from the Brief Pain Inventory (BPI) Pain Severity Scale. Women will be asked to rate 1) worst, 2) least, and 3) average body pain in the 24 hours post-biopsy, as well as 4) current body pain on a scale from 0 (no pain) to 10 (pain as bad as it could be). Consistent with BPI scoring, items will be averaged to create a composite score that had a possible range of 0 to 10 with higher scores indicating greater pain.
Breast pain 24 hours post-biopsy: Brief Pain Inventory (BPI) Pain Severity Scale
Time frame: 24 hours post-biopsy
Breast pain 24 hours post-biopsy will be will be assessed using four questions from the Brief Pain Inventory (BPI) Pain Severity Scale. Women will be asked to rate 1) worst, 2) least, and 3) average breast pain in the 24 hours post-biopsy, as well as 4) current breast pain on a scale from 0 (no pain) to 10 (pain as bad as it could be). Consistent with BPI scoring, items will be averaged to create a composite score that had a possible range of 0 to 10 with higher scores indicating greater pain.
25 secondary outcomes
Number of pre-biopsy body pain sites: Body map
Time frame: Baseline
Number of pre-biopsy breast pain sites: Breast map
Time frame: Baseline
Anticipated body pain: Anticipatory body pain scale
Time frame: Baseline
Anticipated breast pain: Anticipatory breast pain scale
Time frame: Baseline
Anxiety pre-biopsy: State Anxiety Scale of the State-Trait Anxiety Inventory (STAI)
Time frame: Baseline
Likelihood of cancer pre-biopsy: Likelihood of cancer scale
Time frame: Baseline
Pain coping strategies pre-biopsy: Coping Strategies Questionnaire (CSQ)
Time frame: Baseline
Self-efficacy for pain and anxiety pre-biopsy: Self-efficacy for pain and anxiety scale
Time frame: Baseline
Blood pressure pre-biopsy
Time frame: Baseline
Pulse pre-biopsy
Time frame: Baseline
Blood pressure after positioning on the MRI table
Time frame: After positioning on the MRI table, within 1 minute
Pulse after positioning on the MRI table
Time frame: After positioning on the MRI table, within 1 minute
Blood pressure after introducer insertion
Time frame: After last introducer insertion, within 1 minute
Pulse after after introducer insertion
Time frame: After last introducer insertion, within 1 minute
Blood pressure after introducer sheath removal
Time frame: After last introducer sheath removal, within 1 minute
Pulse after introducer sheath removal
Time frame: After last introducer sheath removal, within 1 minute
Anxiety post-biopsy: State Anxiety Scale of the State-Trait Anxiety Inventory (STAI)
Time frame: Post-biopsy, within 1 hour
Likelihood of cancer post-biopsy: Likelihood of cancer scale
Time frame: Post-biopsy, within 1 hour
Distraction from pain during biopsy: Attention to pain scale
Time frame: Post-biopsy, within 1 hour
Distraction from pain during biopsy: Time spent thinking about pain scale
Time frame: Post-biopsy, within 1 hour
Relaxation during biopsy: Relaxation numerical rating scale (NRS)
Time frame: Post-biopsy, within 1 hour
Relaxation during biopsy: Tension Subscale of the Profile of Mood State Short-Form
Time frame: Post-biopsy, within 1 hour
Pain coping strategies post-biopsy: Coping Strategies Questionnaire (CSQ)
Time frame: Post-biopsy, within 1 hour
Self-efficacy for pain and anxiety during biopsy: Self-efficacy for pain and anxiety scale
Time frame: Post-biopsy, within 1 hour
Anxiety 24 hours post-biopsy: State Anxiety Scale of the State-Trait Anxiety Inventory (STAI)
Time frame: 24 hours post-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 25 Sep 2020.
- Individual participant dataSharing planned: No
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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.
Rebecca Shelby, Ph.D. principal investigator
Duke Psychiatry and Behavioral Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Breast Cancer and Breast Pain, 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 4 inclusion and 3 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 25 Sep 2020. 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. 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?
Body pain pre-biopsy: Brief Pain Inventory (BPI) Pain Severity Scale (time frame: Baseline). The study lists 12 primary outcomes in all. 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 25 Sep 2020.