The BEACON Trial: Diagnostic Tools for Breast Lymphedema After Treatment for Breast Cancer
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Tissue Dielectric Constant
研究概览
简要总结
The goal of this observational study is to learn if participants agree to take part in the study, if the methods we are using for the study are feasible for the participants and the researchers, and to study how well two tools (tissue dielectric constant and ultrasound) measure breast edema after breast conserving surgery for breast cancer.
Participants who agree to be in the study will be asked to come in for one appointment of approximately two hours. All data will be collected during this one visit. Participants will be asked to fill out two questionnaires regarding their symptoms, and one questionnaire regarding their surgical scar. The research staff will conduct a clinical examination, measure breast edema using ultrasound and tissue dielectric constant, measure arm volume with the perometer and fluid with the SOZO, and take photographs of both breasts.
详细描述
The goal of this observational study is to learn if the study protocol is feasible, if we can accrue participants easily, and to determine how well two tools (tissue dielectric constant and ultrasound) identify breast edema after breast conserving surgery for breast cancer.
Participants will be asked to attend one appointment in which all data will be collected. This will include questionnaires regarding symptoms, clinical examination, measurement of breast edema using two tools (ultrasound and tissue dielectric constant), measurement with the perometer and SOZO, and clinical photographs.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Tissue Dielectric Constant
时间窗: Baseline
A TDC interbreast ratio ≥ 1.28 in any quadrant will be used as an indicator of breast lymphedema
Breast Ultrasound
时间窗: Baseline
Skin thickness \>1.60 mm in superior and lateral quadrants, \>2.0 mm in the medial and inferior quadrants will be used as an indicator of breast lymphedema.
次要结局
- Patient-Reported Outcome Measures(Baseline)
- Scar Assessment Tool(Baseline)
- Clinical Examination of Lymphedema of the Upper Extremity Clinical Exam Tool(Baseline)
- Clinical Examination - Pitting Edema(Baseline)
- Clinical Examination - Peau d'orange(Baseline)
- Clinical Examination - Erythema(Baseline)
- Clinical Examination - Scar localization(Baseline)
- Clinical Examination - Visual fullness(Baseline)
- Clinical Examination - Tissue thickening(Baseline)
- Clinical Examination - Tissue fibrosis(Baseline)
- Clinical Examination - Tenderness to palpation(Baseline)
- Clinical Examination - Stemmer sign(Baseline)
- Clinical Examination - Skin color changes(Baseline)
研究者
Cheryl Brunelle
Physical Therapy Clinical Specialist, Associate Director, MGH Lymphedema Research Program
Massachusetts General Hospital