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

基本信息

批准号：
10285671
负责人：
Sriram Yennu
金额：
$ 22.72万
依托单位：
UNIVERSITY OF TX MD ANDERSON CAN CTR
依托单位国家：
美国
项目类别：
财政年份：
2021
资助国家：
美国
起止时间：
2021-07-08 至 2023-06-30
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/10285671
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

项目摘要

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.

项目概要背景：对于接受放射治疗（HNC）的头颈癌患者来说，接受放射治疗的频率由于疾病及其治疗，剧烈疼痛可能高达 60% 至 90%。面对阿片类药物危机，人们普遍推动对疼痛患者进行少阿片类药物治疗；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方式。我们的初步数据表明，HNC 患者发生非医疗疾病的风险较高阿片类药物使用 (NMOU) 和较高频率的阳性 CAGE（减少、恼怒、内疚和大开眼界）分数。高NMOU风险使患者及其家人受到伤害，但患者仍需要有效的疼痛宽慰。因此，迫切需要寻找新的有效方法来治疗患者的疼痛患有 NMOU 风险高的 HNC。该提案将重点关注两项有希望的干预措施 NMOU 的不同底层机制。 CHAT（富有同情心的高度戒备小组）是一个密集、手动、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社会心理方面显示出了希望。然而，迄今为止，还没有针对接受治疗的癌症患者的 NMOU 危险行为进行 NFB 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具有 NMOU 行为，但必须服用阿片类药物来治疗疼痛。具体目标： 1. 检验本研究可行的假设，正如足够的比率所定义的那样遵守 CHAT 和 NFB 小组。 2.检查3月底NMOU行为的频率 CHAT、NFB 和 SOC 几个月后。 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[累计吗啡每日当量剂量 (MEDD) 的 AUC] 3 个月结束时对 HNC 患者进行治疗（CHAT、NFB 或 SOC）。 4. 检查皮质和皮质下与疼痛相关的大脑区域和我们的干预措施（CHAT、NFB 和 SOC）以及影响程度脑电图模式的变化调节干预的效果。研究设计：这将是一项 2 期随机对照试验。 HNC 患者将接受筛查寻找 NMOU 风险的证据，并在筛查呈阳性的情况下提供参与研究的机会。患者将被随机分配到 CHAT、NFB 或 SOC。我们将评估 NMOU 的可行性和频率变化行为、疼痛严重程度的变化 [曲线下面积 (AUC)] 和每日阿片类药物累计使用 AUC CHAT、NFB 和 SOC 后 3 个月末的吗啡当量每日剂量 (MEDD)。最后，该提案中的探索性目标将为疼痛、NMOU 行为和疼痛问题产生令人兴奋的新见解。 CHAT 和 NFB 机制。这项研究可以确定两种新的 NMOU 患者管理方法， CHAT 和 NFB 有可能对美国和全世界癌症患者的生活产生积极影响。