Opioid-Sparing Interdisciplinary Interventions Addressing Pain in Head and Neck Cancer Patients

项目总结 背景：对于接受放射治疗(HNC)的头颈部癌症患者， 由于疾病和治疗的原因，严重的疼痛可能高达60%到90%。在面对 在阿片类药物危机期间，人们普遍推动对疼痛患者进行非阿片类药物治疗；然而，这 对于大多数经历疼痛的HNC患者来说，这不是一个可行的选择，因为仍然缺乏替代疼痛 控制模式。我们的初步数据表明，在HNC患者中，非内科疾病的风险更高 阿片类药物使用(NMOU)和更高频率的积极笼子(减少、恼火、内疚和大开眼界) 得分。NMOU的高风险使患者及其家人受到伤害，但患者仍需要有效的疼痛 如释重负。因此，迫切需要找到新的和有效的方法来管理患者的疼痛 有NMOU高风险的HNC。这项提案将重点关注两种有希望的干预措施， NMOU的不同潜在机制。Chat(同情式高度警戒小组)是一种密集的、 管理NMOU高危患者的自动化、跨学科和以患者为中心的方法。 神经反馈(NFB)在控制疼痛以及伴随而来的疼痛的心理社会方面显示出了良好的前景。 然而，到目前为止，还没有关于NFB对接受治疗的癌症患者的NMOU危险行为的研究。 目标：这项工作的长期目标是制定有效的策略来管理癌症患者。 有NMOU行为，但必须给谁开阿片类药物来治疗他们的疼痛。 具体目标：1.检验这项研究将是可行的假设，定义为适当的比率 在Chat和NFB组中坚持使用。2.检查3月末NMOU行为的频率 在聊天、NFB和SOC之后的几个月。3.我们将检查疼痛严重程度[曲线下面积(AUC)]和 每次治疗的每日阿片类药物使用量[吗啡等效日累积剂量的AUC] 3个月末HNC患者的ARMS(CHAT、NFB或SOC)。4.检查大脑皮层和皮质下 与疼痛和我们的干预措施(ChAT、NFB和SOC)相关的大脑区域以及 脑电模式的变化调节了干预的效果。 研究设计：这将是一项第二阶段的随机对照试验。HNC患者将接受筛查 寻找NMOU风险的证据，如果筛查呈阳性，则提供参与研究的机会。病人 将随机分配到Chat、NFB或SOC。我们将评估NMOU的可行性、频率变化 行为、疼痛严重程度的变化[曲线下面积(AUC)]和每日阿片类药物使用的累积AUC 在CHAT、NFB和SOC后3个月末给予吗啡等效日剂量(Medd)。最后， 这项提案的探索性目标将为疼痛问题、NMOU行为和 ChAT和NFB的作用机制。这项研究可以确定NMOU管理的两种新的患者方法， Chat和NFB，有可能对美国和世界各地癌症患者的生活产生积极影响。

PROJECT SUMMARY BACKGROUND: For patients with head and neck cancer receiving radiation therapy (HNC), the frequency of substantial pain may be as high as 60 to 90% due to both the disease and its treatment. In the face of the opioid crisis, there has been a universal push for opioid-sparing treatments in patients with pain; however, this is not a viable option for most HNC patients experiencing pain, as there remains a lack of alternative pain control modalities. Our preliminary data suggest that in HNC patients, there is a higher risk of non-medical opioid use (NMOU) and a higher frequency of positive CAGE (Cut Down, Annoyed, Guilty, and Eye opener) scores. The high NMOU risk exposes patients and their families to harm, but patients still need effective pain relief. There is, therefore, a critical need to find new and effective methods for management of pain in patients with HNC who have a high risk of NMOU. This proposal will focus on two promising interventions targeting different underlying mechanisms of NMOU. CHAT (Compassionate High Alert Team) is an intensive, manualized, interdisciplinary, and patient-centered approach to manage patients with a high risk of NMOU. Neurofeedback (NFB) has shown promise in controlling pain and concomitant psychosocial aspects of pain. However, to date there are no studies of NFB for NMOU risk behaviors in cancer patients receiving treatment. OBJECTIVES: The long-term objective of this work is to devise effective strategies to manage cancer patients with NMOU behaviors, but who must be prescribed an opioid to treat their pain. SPECIFIC AIMS: 1. To test the hypothesis that this study will be feasible, as defined by adequate rates of adherence in the CHAT and NFB groups. 2. To examine the frequency of NMOU behaviors at the end of 3 months after CHAT, NFB, and SOC. 3. We will examine the pain severity [area under the curve (AUC)] and daily opioid use [AUC of the cumulative morphine equivalent daily dose (MEDD)] for each of the treatment arms (CHAT, NFB, or SOC) in HNC patients at the end of 3 months. 4. To examine the cortical and subcortical regions of the brain associated with pain and our interventions (CHAT, NFB, and SOC) and the extent to which changes in EEG patterns mediate the effects of the intervention. RESEARCH DESIGN: This will be a Phase 2 randomized controlled trial. Patients with HNC will be screened for evidence of NMOU risk and offered the opportunity to participate in the study if they screen positive. Patients will be randomized to either CHAT, NFB, or SOC. We will assess the feasibility, change in frequency of NMOU behaviors, change in pain severity [area under the curve (AUC)] and daily opioid use AUC of the cumulative morphine equivalent daily dose (MEDD) at the end of 3 months after CHAT, NFB, and SOC. Finally, the exploratory aim in this proposal will generate exciting new insight into the problem of pain, NMOU behavior, and mechanisms of CHAT and NFB. This study could identify two novel patient approaches to NMOU management, CHAT and NFB, with the potential to positively impact the lives of cancer patients across the U.S. and worldwide.