Remote Monitoring of Management of Chemotherapy induced Peripheral Neuropathy

化疗所致周围神经病(CIPN)是化疗后常见的致残性副作用。 它经常导致化疗剂量改变、疼痛、跌倒风险和增加医疗费用。病征 尽管存在阿片类药物危机，但报告不足、治疗不足和治疗往往偏离指导方针。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相结合的研究改善了6个月的健康 相关的生活质量和癌症存活率。在化疗期间，我们的研究与CIPN症状报告配对 与护士从业者(NP)的回叫工具导致CIPN症状减少75%。(这种护理模式是 称为家庭症状护理与NP随访(Sch-NP)。该系统在化疗后的疗效观察 当CIPN症状最严重，医生不经常就诊时，仍有待研究。拟议的RCT将 在症状最严重的时期检查SCH-NP治疗，使用标准化指南 基于护理协议，允许基于电话、应用程序和网络的症状报告并确定疗效 使用神经病变的特定结果。这项研究的总体目标是证明一种新的 便于症状报告和主动治疗管理的护理模式，以减少CIPN症状。 具体目的1：确定SCH-NP与常规护理(UC)减少化疗后CIPN的疗效 症状超过12周。我们假设SCH-NP将减少神经病变的CIPN症状 症状总评分6分(NTSS6)。358名新近确诊的CIPN患者将随机接受12周的UC治疗 或者是sch-np护理。这两组人每天都会通过电话、应用程序或网站报告症状。UC组将收到 通过他们的主治医生提供标准护理。在报告中度到重度症状的SCH-NP组中 将触发NP回电，以提供基于证据的程序化治疗，包括药物、自我护理 战略和推荐。将使用NTSS6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在改善CIPN特定生活质量和 残疾。我们假设，与UC相比，SCH-NP护理将改善CIPN特定的生活质量 (EORTC CIPN 20)和通过重复协方差分析测量的减少残疾(CIPN-RODS)。 具体目标3：确定SCH-NP与UC对阿片类药物使用和现有CIPN利用的影响 治疗。我们假设SCH-NP护理将减少阿片类药物的使用，以≥50 Mme/的受试者百分比衡量 一天(高风险)和提高CIPN治疗利用率，包括神经病理性疼痛药物的使用，开处方的时间， 选择正确的治疗方法、足够的滴定、最大药物剂量和CIPN治疗总数。 这项创新的研究利用了一种新的基于技术的模型来绕过CIPN护理中的障碍。这个 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医疗保健机会减少。

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.