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Focal Breast Pain: Does a Normal Ultrasound Provide Reassurance?

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02810236
Recruitment Status : Suspended (The study is suspended due to the pandemic)
First Posted : June 22, 2016
Last Update Posted : August 27, 2020
Sponsor:
Information provided by (Responsible Party):
Duke University

Brief Summary:
The investigator hypothesizes that a benign directed ultrasound, when performed after a normal digital mammogram, will provide women with focal breast pain additional reassurance that the etiology of their symptom is benign. 160 women over the age of thirty with focal breast pain who present to the Breast Imaging Clinic for evaluation between 3/1/2016 - 7/1/2018 will be selected and randomized to three groups using a block randomization technique. All study participants will complete a survey assessing psychosocial factors, then receive a digital mammogram. Patients with a negative mammogram will continue on with the study and will either have a conversation about their negative mammogram with a radiologist or receive a directed ultrasound. A second survey will be conducted assessing psychosocial factors. All study participants who did not receive an ultrasound will receive an ultrasound so that all study participants are provided with the standard of care for focal breast pain. The results of the survey will be compared and appropriate statistical analyses such as an Analysis of Variance (ANOVA) test will be conducted to determine any statistically significant differences between the three randomized groups. The risks/safety issues of this study are believed to be minimal.

Condition or disease Intervention/treatment Phase
Breast Diseases Mastodynia Anxiety Procedure: Ultrasound Behavioral: Discussion Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Diagnostic
Official Title: Focal Breast Pain: Does a Normal Ultrasound Provide Reassurance?
Actual Study Start Date : February 13, 2018
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: No ultrasound
No ultrasound recommended. Discussion with radiologist.
Behavioral: Discussion
Radiologist will discuss with the patient the findings on mammogram.

Active Comparator: Ultrasound
Ultrasound recommended.
Procedure: Ultrasound
Ultrasound will be performed.




Primary Outcome Measures :
  1. Change in anxiety using modified STAI questionnaire [ Time Frame: baseline, day 1 ]
    Measure change in anxiety following intervention using modified STAI



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   30 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • women
  • over the age of 30
  • primary focal breast pain, i.e. pain localizable by the patient to within one breast quadrant without other associated symptoms.

Exclusion Criteria:

  • diffuse, radiating, or axillary pain
  • associated palpable findings at the site of pain
  • skin changes (erythema, thickening)
  • nipple changes (discharge, retraction)
  • currently pregnant or breast-feeding
  • history of recent trauma or infection of the affected breast
  • history of ipsilateral breast cancer will be excluded.

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): NCT02810236


Locations
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United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
Sponsors and Collaborators
Duke University
Investigators
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Principal Investigator: Karen Johnson, MD Duke University
Principal Investigator: Lars Grimm, MD Duke University
Publications:
Jokich P, Newell MS, Bailey L, et al. ACR Appropriateness Criteria® breast pain. Available at http://www.acr.org/~/media/ACR/Documents/AppCriteria/Diagnostic/ BreastPain.pdf. American College of Radiology. Accessed June 20, 2015.
Harvey JA, Mahoney MC, Newell MS, et al. ACR Appropriateness Criteria® palpable breast masses. Available at http://www.acr.org/~/media/ACR/Documents/AppCriteria/Diagnostic/PalpableBreastMasses.pdf. American College of Radiology. Accessed June 20, 2015.
Spielberger CD. Manual for the State-Trait Anxiety Inventory (Form Y). Palo Alto, CA: Mind Garden; 1983.

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Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT02810236    
Other Study ID Numbers: Pro00070445
First Posted: June 22, 2016    Key Record Dates
Last Update Posted: August 27, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Duke University:
Focal breast pain
Directed Ultrasound
Reassurance
Anxiety
Additional relevant MeSH terms:
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Breast Diseases
Mastodynia
Skin Diseases
Pain
Neurologic Manifestations