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 : March 11, 2021
|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 :||March 31, 2022|
|Estimated Study Completion Date :||March 31, 2022|
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:||Michael Taylor-Cho, MD||Duke University|
|Principal Investigator:||Lars Grimm, MD||Duke University|