Bioelectrical Impedance for Self-Monitoring of Breast Cancer Related Lymphedema

生物电阻抗用于乳腺癌相关淋巴水肿的自我监测

• 批准号: 8114641
• 负责人: Sheila H Ridner
• 金额: $ 23.36万
• 依托单位: VANDERBILT UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2011
• 资助国家: 美国
• 起止时间: 2011-04-01 至 2013-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8114641
• 关键词: Affect; Aftercare; Antibiotics; Area; Bandage; Biolectric Impedance; Blood Glucose; Breast Cancer Treatment; Cancer Survivor; Caring; Cellulitis; Chronic; Chronic Disease; Data; Devices; Diabetes Mellitus; Feeling; Frequencies; Future; Goals; Hand; Health; Health Care Costs; Home environment; Individual; Infection; Institutes; Intervention Studies; Laboratories; Late Effects; Life; Life Experience; Limb structure; Lymphedema; Manual Lymphatic Drainage; Measurement; Measures; Medical; Medical History; Methods; Monitor; National Cancer Institute; National Institute of Nursing Research; Normal Range; Outcome; Output; Participant; Patients; Phase; Pilot Projects; Productivity; Protocols documentation; Quality of life; Randomized Clinical Trials; Reading; Reporting; Research; Resistance; Risk; Self Care; Self Care outcome; Self Efficacy; Self Management; Self-Administered; Sentinel Lymph Node; Skin; Skin Care; Staging; Swelling; Symptoms; Testing; Therapeutic; Thick; Time; United States Food and Drug Administration; Visual; Work; arm; base; cancer therapy; care seeking; diabetic; economic outcome; electric impedance; experience; follow-up; health economics; healthy volunteer; improved; malignant breast neoplasm; pressure; protocol development; standard care; symptom management; treatment duration

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.

描述(申请人提供)：乳腺癌治疗相关的淋巴水肿(肿胀)是一种不可治愈的慢性疾病，有相当大比例的乳腺癌幸存者经历过。它有许多相关症状，对生活质量(QOL)产生负面影响，并增加医疗费用。与糖尿病等其他慢性病一样，需要终生自我护理。不到一半的乳腺癌幸存者按照指导完成了自我护理。缺乏自我护理的感知结果，以及感觉无法管理这种情况是促成因素。没有客观的测量机制可以很容易地用于自我监测手臂体积，这是一种关键的自我护理结果。淋巴水肿者被迫依靠增加体积的视觉识别来知道他们的自我护理是否有效，以及何时寻求治疗。及时认识到不断恶化的肿胀被认为会导致更好的患者预后；然而，在注意到可观察到的变化之前，体积就会大幅增加，这一机会窗口往往被错过。许多淋巴水肿者只有在肿胀的肢体出现感染时才寻求治疗。不能定期客观地监测手臂的体积可能会导致不适、较差的生活质量和增加的医疗费用。国家癌症研究所的目标是提高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改善生活质量的关键领域。为了与这些研究所的目标保持一致，这项应用的广泛、长期目标是开发一种监测手臂淋巴水肿的方法，这种方法可以在家里使用，以改善淋巴水肿的自我管理和患者的预后。为了实现这一点，我们将进行一项分两个阶段的平移试点研究，以探索手持生物电阻抗装置作为手臂体积自我测量方法的使用。在之前的研究中，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。第一阶段旨在开发一种生物电阻抗自我测量方案。第二阶段旨在比较乳腺癌幸存者和乳腺癌幸存者之间的自我护理活动以及健康和经济结果。健康志愿者和有淋巴水肿症的人将进入第一阶段(方案制定)。这将在实验室和家庭环境中进行。该方案将在第二阶段(两组随机临床试验)患有淋巴水肿的乳腺癌幸存者中进行现场测试。其中一组将在家中进行为期三个月的阻抗自我测量，每周记录自我护理活动，并在退出研究30天后完成随访评估。另一组将反映第一组，但阻抗测量除外，并将在同一时间点完成所有评估。将从所有参与者那里收集人口统计和病史数据。在第二阶段，将收集基线和每月评估。这项研究的结果将被用来确定生物电阻抗作为一种自我测量方法是否值得进一步研究。 公共卫生相关性：乳腺癌幸存者在治疗后经常出现永久性手臂肿胀，自我护理对于在一定程度上控制肿胀至关重要。需要一种测量手臂的方法来评估有效的自我护理并辨别何时就医。这项研究将测试一种自我测量装置。