Remote Monitoring of Management of Chemotherapy induced Peripheral Neuropathy

化疗引起的周围神经病变管理的远程监控

• 批准号: 10658846
• 负责人: Noah Allan Kolb
• 金额: $ 50.06万
• 依托单位: UNIVERSITY OF VERMONT & ST AGRIC COLLEGE
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-05-06 至 2027-04-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10658846
• 关键词: Accidents; Aftercare; Algorithms; Callback; Cancer Survivor; Caring; Chemotherapy-induced peripheral neuropathy; Consensus; Consumption; Data; Dependence; Diagnosis; Dose; Emerging Technologies; European Organization for Research and Treatment of Cancer; FDA approved; Fright; Gait; Goals; Guidelines; Hand; Health Care Costs; Health Services Accessibility; Health system; Home; Hybrids; Individual; Internet; Intervention; Knowledge; Life; Malignant Neoplasms; Measures; Mediation; Modality; Modeling; Monitor; Morbidity - disease rate; Neuropathy; Nurse Practitioners; Nurses; Office Visits; Online Systems; Opioid; Outcome; Pain; Participant; Patients; Pharmaceutical Preparations; Physicians; Preventive treatment; Prospective Studies; Protocols documentation; Publishing; Quality of life; Randomized; Recommendation; Reporting; Resource-limited setting; Risk; Running; Rural; Self Care; Sensory; Signs and Symptoms; Substance abuse problem; Symptoms; System; Technology; Telemedicine; Telephone; Time; Titrations; Visit; Withholding Treatment; active method; cancer survival; chemotherapy; comparison control; disability; efficacy evaluation; evidence base; fall risk; follow-up; foot; health care availability; health related quality of life; high risk; improved; innovation; mobile application; neurotoxic; new technology; novel; opioid epidemic; opioid mortality; opioid use; painful neuropathy; personalized care; prescription opioid; prevent; prospective; remote monitoring; response; secondary outcome; side effect; standard care; standardize guidelines; symptom management; symptomatic improvement; telephone based; tool; treatment as usual; treatment duration; web site

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.

化疗引起的周围神经病变（CIPN）是化疗常见的致残性副作用。