Focal Breast Pain: Does a Normal Ultrasound Provide Reassurance?
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Change in anxiety using modified STAI questionnaire
研究概览
简要总结
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.
详细描述
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 utility in women with non-dense breast tissue. These findings suggest that directed ultrasound might be unnecessary in the work up of focal breast pain for women with non-dense breast tissue.
However, there is anecdotal evidence that a directed ultrasound yielding benign findings following a normal digital mammogram might further reassure women that the cause of focal breast pain is benign. These potential psychological benefits may drive the continued use of ultrasound in the work up of focal breast pain, even though their diagnostic utility is low.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 30 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Change in anxiety using modified STAI questionnaire
时间窗: baseline, day 1
Measure change in anxiety following intervention using modified STAI
次要结局
未报告次要终点