Clinical Trial: Focal Breast Pain: Does a Normal Ultrasound Provide Reassurance?

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

Official Title: Focal Breast Pain: Does a Normal Ultrasound Provide Reassurance?

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.

Detailed Summary:

Protocol Title: Focal Breast Pain: Does a normal ultrasound provide reassurance?

Purpose of the Study: 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.

Background & Significance: Breast pain is one of the most common symptoms for which women seek medical care. While up to 80% of women experience breast pain at some point in their lives, most commonly breast pain results from a benign etiology such as trauma, infection, pregnancy, lactation, or simple cysts. In contrast, breast cancer is only reported in up to 7% of women presenting with focal breast pain. Despite the uncommon association between breast cancer and focal breast pain, a diagnostic imaging workup is often requested. Current American College of Radiology (ACR) Appropriateness Criteria guidelines rate the use of mammography and ultrasound for the evaluation of non-cyclical, focal, unilateral or bilateral breast pain in patients 30 years and older as "may be appropriate." Traditionally both mammography and ultrasound are performed in women over the age of 30, who present with noncyclical, focal breast pain as imaging can often exclude a treatable benign cause of pain and/or provide reassurance.

The investigator recently completed a retrospective study evaluating the utility of digital mammography and directed ultrasound in women with focal breast pain. It was observed that performing directed ultrasound following digital mammography was potentially beneficial in women with mammographically dense breast tissue. In contrast, the investigator demonstrated that directed ultrasound in conjunction with digital mammography was of low
Sponsor: Duke University

Current Primary Outcome: Change in anxiety using modified STAI questionnaire [ Time Frame: baseline, day 1 ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Duke University

Dates:
Date Received: May 23, 2016
Date Started: July 2017
Date Completion: June 2018
Last Updated: April 21, 2017
Last Verified: April 2017