Bioelectrical Impedance for Self-Monitoring of Breast Cancer Related Lymphedema

描述（由申请人提供）：乳腺癌治疗相关性水肿（肿胀）是一种不可治愈的慢性疾病，有相当比例的乳腺癌幸存者会经历这种疾病。它有许多相关症状，对生活质量（QOL）产生负面影响，并增加医疗保健费用。与糖尿病等其他慢性疾病一样，需要终身自我护理。不到一半的乳腺癌幸存者按照指示完成自我护理。缺乏自我护理的感知结果和感觉无法管理的条件是促成因素。没有客观的测量机制存在，可以很容易地用于自我监测手臂的体积，一个关键的自我保健的结果。那些患有水肿的人被迫依靠不断增加的视觉识别来了解他们的自我护理是否有效以及何时寻求治疗。认为及时识别肿胀恶化可获得更好的患者结局;然而，在观察到可观察到的变化之前，体积会大幅增加，并且经常错过这一机会窗口。许多患有水肿的人只有在肿胀的肢体发生感染时才寻求护理。无法定期客观监测手臂体积可能会导致不适、QOL较差和医疗保健费用增加。美国国家癌症研究所旨在改善癌症幸存者的生活质量。国家护理研究所指出，自我管理和症状管理是提高生活质量的关键领域。与这些研究所的目标一致，本申请的广泛、长期目标是开发一种用于监测手臂水肿的方法，该方法可以在家中使用，以改善水肿自我管理和患者结局。为了实现这一点，我们将进行一个两阶段，平移试点研究，探索使用手持生物电阻抗设备作为手臂体积自我测量方法。在以前的研究中，参与者一再表示希望在家里使用这些设备来监测他们的手臂，“就像糖尿病患者监测他们的血糖一样。“第一阶段的目标是开发一个生物电阻抗自我测量协议。第2阶段旨在比较遵循自我监测方案的患有水肿的乳腺癌幸存者与未遵循方案的患有水肿的乳腺癌幸存者之间的自我护理活动以及健康和经济结局。健康志愿者和水肿个体将进入I期（方案制定）。这将在实验室和家庭环境中进行。该方案将在2期（两组随机临床试验）中由患有水肿的乳腺癌幸存者进行现场测试。一组将在家中用阻抗自我测量三个月，每周记录自我护理活动，并在退出研究后30天完成随访评估。除阻抗测量外，另一组将与第1组相同，并将在相同时间点完成所有评估。将收集所有受试者的人口统计学和病史数据。在第2阶段，将收集基线和每月评估。这项研究的结果将用于确定生物电阻抗是否值得进一步研究作为一种自我测量方法。 公共卫生相关性：乳腺癌幸存者在治疗后经常遭受永久性的手臂肿胀，自我护理对于控制肿胀至关重要。需要一种进行手臂测量的方法来评估有效的自我护理和辨别何时寻求医疗。本研究将测试自我测量装置。

DESCRIPTION (provided by applicant): Breast cancer treatment-related lymphedema (swelling) is an incurable, chronic condition experienced by a significant percentage of breast cancer survivors. It has many associated symptoms, negatively impacts quality of life (QOL), and increases health care costs. As with other chronic diseases such as diabetes, life-long self- care is required. Less than half of breast cancer survivors complete self-care as directed. Lack of perceived results from self-care and feeling unable to manage the condition are contributing factors. No objective measurement mechanism exists that can easily be used to self-monitor arm volume, a key self-care outcome. Those with lymphedema are forced to rely on visual recognition of increasing volume to know if their self-care is effective and when to seek treatment. Timely recognition of worsening swelling is believed to result in better patient outcomes; however, substantial volume increases occur before observable changes are noted and this window of opportunity is often missed. Many with lymphedema seek care only when they have developed infection in the swollen limb. The inability to objectively monitor arm volume on a regular basis likely results in discomfort, poorer QOL, and increased health care costs. The National Cancer Institute aims to improve QOL for cancer survivors. The National Institute of Nursing Research states that self-management and symptom management are key areas in the improvement of QOL. In keeping with these Institutes' aims, the broad, long- term objective of this application is to develop a method for monitoring arm lymphedema that can be used at home to improve lymphedema self-management and patient outcomes. To accomplish this, we will conduct a two-phase, translational pilot study to explore the use of a hand-held bioelectrical impedance device as an arm volume self-measurement method. Participants in previous studies have repeatedly expressed the desire to use these devices at home to monitor their arms "like diabetics monitor their blood sugar." Phase 1 aims to develop a bioelectrical impedance self-measurement protocol. Phase 2 aims to compare self-care activities and health and economic outcomes between breast cancer survivors with lymphedema following the self- monitoring protocol and breast cancer survivors with lymphedema not on protocol. Healthy volunteers and individuals with lymphedema will be in Phase 1 (protocol development). This will take place in laboratory and home settings. The protocol will be field-tested by breast cancer survivors with lymphedema in Phase 2 (a two group randomized clinical trial). One group will self-measure with impedance at home for three months, weekly record self-care activities, and will complete follow-up assessments 30 days after exit from the study. The other group will mirror Group 1 except for impedance measurements and will complete all assessments at the same time points. Demographic and medical history data will be collected from all participants. In Phase 2, baseline and monthly assessments will be collected. Findings from this study will be used to determine if bioelectrical impedance warrants further research as a self-measurement method. PUBLIC HEALTH RELEVANCE: Breast cancer survivors often suffer permanent swelling in arms post-treatment, and self-care is crucial to keep swelling somewhat under control. A means to perform arm measurement is needed to evaluate effective self- care and discern when to seek medical treatment. This research will test a self-measurement device.