A Feasibility Study Evaluating the Impact Flexitouch Plus With Connectivity Has on Compliance in Patients With Breast Cancer-Related Lymphedema (BCRL)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 29
- 试验地点
- 6
- 主要终点
- Compliance Measured as the Average Number of Treatments Per Week
研究概览
简要总结
The objective of this study is to demonstrate the feasibility of using the Flexitouch Plus with Cellular Connectivity (FT-CC) to monitor device use data to determine if reminders to patients impact compliance, and to identify the impact device compliance has on arm girth, quality of life (QOL), and symptom assessment.
详细描述
This is a multi-center, on label, prospective, randomized, two-arm feasibility study that plans to enroll 30 female subjects in the United States. In an effort to reduce potential exposure to COVID-19, all study assessments are intended to be performed in a contactless manner (i.e., telephone, video conference, etc). If a subject passes the initial screening requirements via medical history and expresses interest in the study an informed consent form will be provided to them. Once consent has been obtained they will undergo a baseline visit where they will be randomized to one of two treatment groups: PASSIVE FT-CC (text messages reminders will not be sent to subjects) and ACTIVE FT-CC (text messages reminders will be sent if subject does not use the device for 2 consecutive days). Randomization was incorporated into the study to determine if ACTIVE FT-CC affects device use. A total of 2 follow-up visits will be conducted over a 60-day period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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
- •Female 18 years of age or older
- •Diagnosis of unilateral breast cancer-related lymphedema
- •Willing and able to give informed consent (remotely or in person)
- •Willing and able to comply with the study protocol requirements and all study-related visit requirements, including the ability to participate remotely
- •Willing and able to receive text messages from sponsor
排除标准
- •In-home use of PCD within previous 3 months
- •Phase-one CDT within previous 1 month or planned phase-one CDT during study participation Phase-one CDT defined as professionally administered MLD and/or multi-layer short stretch compressive bandaging.
- •Inability to be fit for PCD garments
- •Heart failure (acute pulmonary edema, decompensated acute heart failure)
- •Acute venous disease (acute thrombophlebitis, acute deep venous thrombosis, acute pulmonary embolism)
- •Active skin or limb infection/inflammatory disease (acute cellulitis, other uncontrolled skin or untreated inflammatory skin disease) on the arms or trunk
- •Currently receiving treatment for cancer with curative intent.
- •Any circumstance where increased lymphatic or venous return is undesirable
- •Currently pregnant or trying to become pregnant
- •Known inability to receive cell phone connection where FT-CC therapy will be administered
结局指标
主要结局
Compliance Measured as the Average Number of Treatments Per Week
时间窗: 60 Days
Compare the rate of compliance in patients treated with PASSIVE FT-CC and ACTIVE FT-CC.
次要结局
- Compliance With Device Use.(Through 60 days after device training)
- Quality of Life Assessment Via LYMQOL ARM(Changes through 60 days after device training)
- Quality of Life Assessment Via SF-36 Physical Functioning Domain Score(Changes through 60 days after device training)
- Quality of Life Assessment Via LSIDS-A Score(Changes through 60 days after device training)