Focal Breast Pain: Does a Normal Ultrasound Provide Reassurance?
|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
|Condition or disease||Intervention/treatment||Phase|
|Breast Diseases Mastodynia Anxiety||Procedure: Ultrasound Behavioral: Discussion||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||160 participants|
|Intervention Model:||Parallel Assignment|
|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|
Active Comparator: No ultrasound
No ultrasound recommended. Discussion with radiologist.
Radiologist will discuss with the patient the findings on mammogram.
Active Comparator: Ultrasound
Ultrasound will be performed.
- Change in anxiety using modified STAI questionnaire [ Time Frame: baseline, day 1 ]Measure change in anxiety following intervention using modified STAI
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
|United States, North Carolina|
|Duke University Medical Center|
|Durham, North Carolina, United States, 27710|
|Principal Investigator:||Karen Johnson, MD||Duke University|
|Principal Investigator:||Lars Grimm, MD||Duke University|