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

减少阿片类药物的跨学科干预措施解决头颈癌患者的疼痛

• 批准号: 10447805
• 负责人: Sriram Yennu
• 金额: $ 18.56万
• 依托单位: UNIVERSITY OF TX MD ANDERSON CAN CTR
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-07-08 至 2024-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10447805
• 关键词: Address; Alcohol consumption; Anxiety; Area Under Curve; Behavior; Behavioral Mechanisms; Brain; Brain region; Cancer Center; Cancer Patient; Clinical; Custom; Data; Disease; Dose; Electroencephalogram; Ethics; Etiology; Eye; Family; Frequencies; Goals; Gold; Head and Neck Cancer; Health; Hospitals; Human Papillomavirus; Incidence; Intervention; Investigation; Light; Literature; Malignant Neoplasms; Measures; Mediating; Mental Depression; Methodology; Modality; Moods; Opioid; Outcome; Pain; Pain Management Method; Pain intensity; Pain management; Participant; Patients; Pattern; Phase; Physiological Processes; Pilot Projects; Quality of life; Questionnaires; Radiation therapy; Randomized; Randomized Controlled Trials; Research Design; Risk; Risk Behaviors; Risk Factors; Secondary to; Severities; Smoking History; Standardization; Symptoms; Techniques; Testing; Therapeutic; Time; Work; addiction; adherence rate; adverse outcome; base; behavior change; cancer pain; clinically relevant; common symptom; disabling symptom; effective therapy; experience; head and neck cancer patient; high risk; insight; intervention effect; morphine equivalent; neurofeedback; neuroregulation; novel; opioid epidemic; opioid misuse; opioid sparing; opioid therapy; opioid use; pain reduction; pain relief; patient oriented; prescription opioid; psychological distress; psychosocial; standard care; standard of care; treatment arm

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.

项目摘要 背景：对于接受放射治疗（HNC）的头颈癌患者， 由于疾病及其治疗，实质性疼痛可能高达60%至90%。在面对 阿片类药物危机，一直在普遍推动疼痛患者的阿片类药物保守治疗;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 控制方式。我们的初步数据表明，在HNC患者中， 阿片类药物使用（NMOU）和更高频率的积极CAGE（削减，烦恼，内疚和大开眼界） 成绩. NMOU的高风险使患者及其家人受到伤害，但患者仍然需要有效的疼痛 救灾因此，迫切需要找到新的和有效的方法来管理患者的疼痛 有高风险NMOU的HNC患者。该提案将侧重于两项有希望的干预措施， NMOU的不同潜在机制。CHAT（Companies High Alert Team）是一个密集的， 手动化、跨学科和以患者为中心的方法来管理NMOU高风险患者。 神经反馈（NFB）在控制疼痛和伴随的疼痛心理方面显示出希望。 然而，到目前为止，还没有研究NFB的NMOU风险行为的癌症患者接受治疗。 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 与NMOU行为，但谁必须规定阿片类药物来治疗他们的疼痛。 具体目标：1.为了检验本研究可行的假设，如适当的比率所定义， CHAT和NFB组的依从性。2.检查NMOU行为在3结束时的频率 在CHAT、NFB和SOC之后的几个月。我们将检查疼痛严重程度[曲线下面积（AUC）]， 每种治疗的每日阿片类药物使用量[累积吗啡等效日剂量（MEDD）的AUC] 在3个月结束时，HNC患者中的CHAT、NFB或SOC组。4.检查大脑皮层和皮层下 与疼痛相关的大脑区域和我们的干预措施（CHAT，NFB和SOC）以及 EEG模式的变化介导了干预的效果。 研究设计：这是一项2期随机对照试验。将筛选HNC患者 获得NMOU风险的证据，并提供机会参加研究，如果他们筛选阳性。患者 将被随机分配到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）]和累积的每日阿片类药物使用AUC 在CHAT、NFB和SOC后3个月结束时的吗啡等效日剂量（MEDD）。最后， 本提案的探索性目标将产生令人兴奋的新的洞察力的问题，疼痛，NMOU的行为， CHAT和NFB的机制。这项研究可以确定两种新的患者方法来管理NMOU， CHAT和NFB，有可能对美国和全球癌症患者的生活产生积极影响。