Remote Monitoring of Management of Chemotherapy induced Peripheral Neuropathy

化疗引起的周围神经病变（CIPN）是一种常见的和致残的化疗副作用。 它经常导致化疗剂量改变，疼痛，跌倒风险和医疗保健费用增加。症状 尽管存在阿片剂危机，但报告不足、治疗不足和治疗往往偏离准则。那里 迫切需要实施有效的证据和共识驱动的CIPN管理。 将化疗相关症状报告工具与护士随访配对的研究改善了6个月的健康状况 相关的生活质量和癌症存活率。在化疗期间，我们的研究将CIPN症状报告与 具有执业护士（NP）回叫的工具导致CIPN症状减少75%。(This护理模式是 称为具有NP随访的家庭症状护理，SCH-NP）。化疗后该系统的疗效 当CIPN症状最严重时，医生的访问很少，仍然是未知的。拟议的RCT将 在症状最严重期间检查SCH-NP治疗，使用标准化指南 基于护理方案，允许基于电话、应用程序和网络的症状报告并确定疗效 使用神经病变特异性结果。本研究的总体目标是证明一种新的 护理模式，促进症状报告和积极的治疗管理，以减少CIPN症状。 具体目标1：确定SCH-NP与常规治疗（UC）相比减少化疗后CIPN的疗效 症状超过12周我们假设SCH-NP将减少神经病变测量的CIPC症状 总症状评分6（NTSS 6）。358例近期确诊的CIPN患者将随机接受12周UC治疗 或SCH-NP护理。这两组人每天都将通过电话、应用程序或网站报告症状。UC集团将获得 通过他们的主治医生进行标准治疗。在报告中度至重度症状的SCH-NP组中， 将触发NP回电，以提供循证方案化治疗，包括药物治疗、自我护理 战略和转介。将使用NTSS 6协方差的重复测量分析来比较组。 具体目标2：确定SCH-NP与UC相比在改善CIPN特异性生活质量方面的疗效， 残疾。我们假设，与UC相比，SCH-NP治疗将改善CIPN特定的生活质量 （EORTC CIPN 20）和减少残疾（CIPN-RODS）通过重复协方差分析测量。 具体目标3：确定SCH-NP与UC对阿片类药物使用和可用CIPN利用的影响 治疗我们假设SCH-NP治疗将减少阿片类药物的使用，以≥ 50 MME/ 天（高风险）和改善CIPN治疗利用率，包括神经性疼痛药物的使用，处方时间， 选择正确的治疗、适当的滴定、最大药物剂量和CIPN治疗的总次数。 这项创新的研究利用一种新的基于技术的模型来绕过CIPN护理中的障碍。的 这项研究的广泛影响和实质性意义来自于该模型为那些在 资源贫乏的地区，在最需要的时候获得医疗保健的机会减少。

Chemotherapy induced peripheral neuropathy (CIPN) is a common and disabling side effect of chemotherapy. It frequently leads to chemotherapy dose alteration, pain, fall risk, and increased health care costs. Symptoms are under reported, under treated and treatment often deviates from guidelines despite the opiate crisis. There is an urgent need for implementation of effective evidence and consensus driven CIPN management. Studies pairing a chemotherapy related symptom reporting tool with nurse follow up improved 6 month health related quality of life and cancer survival. During chemotherapy, our studies pairing a CIPN symptom reporting tool with nurse practitioner (NP) call back resulted in a 75% reduction in CIPN symptoms. (This care model is called Symptom Care at Home with NP follow up, SCH-NP). The efficacy of this system post chemotherapy when CIPN symptoms are worst and doctors visits are infrequent remains unexplored. The proposed RCT will examine SCH-NP treatment during the period of maximal symptoms, utilize a standardized guideline based care protocol, allow for phone, app and web based symptom reporting and determine efficacy using neuropathy specific outcomes. The overall goal of this study is to demonstrate the efficacy of a new care model that facilitates symptom reporting and proactive treatment management to reduce CIPN symptoms. Specific Aim1: Determine the efficacy of SCH-NP vs. usual care (UC) to reduce post chemotherapy CIPN symptoms over 12 weeks. We hypothesize SCH-NP will reduce CIPN symptoms measured on the Neuropathy Total Symptom Score 6 (NTSS6). 358 recently diagnosed CIPN patients will be randomized to 12 weeks of UC or SCH-NP care. Both groups will report symptoms daily via phone, app or website. The UC group will receive standard care through their treating physicians. In the SCH-NP group reporting moderate to severe symptoms will trigger NP call back to provide evidence-based protocolized treatment including medications, self-care strategies and referrals. Repeated measure analysis of the NTSS6 covariance will be used to compare groups. Specific Aim 2: Determine the efficacy of SCH-NP vs. UC in improving CIPN specific quality of life and disability. We hypothesize that compared to UC, SCH-NP care will improve CIPN specific quality of life (EORTC CIPN 20) and reduce disability (CIPN-RODS) measured by repeated covariance analysis. Specific Aim 3: Determine the impact of SCH-NP vs. UC on opiate usage and the utilization of available CIPN therapies. We hypothesize SCH-NP care will reduced opiate use measured by % of subjects on ≥ 50 MME/ day (high risk) and improve CIPN therapy utilization including neuropathic pain med use, time to prescription, selection of the correct therapy, adequate titration, max drug doses, and total number of CIPN treatments. This innovative study utilizes a novel technology based model to circumnavigate roadblocks in CIPN care. The study’s broad impact and substantial significance derive from the model’s ability to deliver care to those in resource poor areas with reduced healthcare access in their time of greatest need.