Efficacy and Mechanistic Testing of a Self-Management Intervention for Managing Chronic Pain with Cancer Survivors

项目概要/摘要 拟议的K23奖支持琳达伊顿博士成为一名成功的护士的职业发展 能够领导多学科团队推进症状科学的科学家。她的长期目标是 通过开发有效的症状自我管理方法改善患者结局，并了解 这些干预的生物学和心理学机制。第一步是建立 记录催眠干预（RHI）减轻慢性疼痛的有效性。 本K23提案通过为Eaton博士提供（1）团队科学，（2） 预测对疼痛管理方法的反应的生物标志物，以及（3）进一步的研究技能，包括 调解人-主持人分析，以评估干预措施。伊顿博士的主要导师Ardith Doorenbos博士 （护理）和共同导师，玛格丽特Heitkemper博士（护理），博士马克P.詹森（康复），提供 在症状科学，团队科学，生物标志物研究和使用催眠减轻疼痛方面的专业知识。 拟议的研究解决了开发安全有效的疼痛管理的迫切需要 战略布局慢性疼痛影响了美国近1600万癌症幸存者中的三分之一以上。 自我管理干预-如催眠-已被证明对许多非癌症慢性 疼痛状况，很少有不良影响，可能是一种替代或补充的方法， 药物治疗.然而，由于其不方便和成本（例如，需要多次预约 有经验的临床医生），催眠很少用于慢性疼痛管理。RHI提供了一个 一种可能减轻已完成活动的癌症幸存者疼痛的替代给药方法 治疗，不再有疾病的迹象。需要确定这种干预的机制 因此，它可以精确地应用于癌症幸存者的慢性疼痛管理。的科学目的 这项随机对照试验将（1）评估RHI在减轻自我报告的疼痛强度方面的功效 （主要结局），疼痛干扰、焦虑、抑郁、疲劳和睡眠障碍（次要结局） 在4周时与注意力控制条件（音乐记录）相比;（2）检查是否有心理因素 （催眠的可接受性、精神吸收、治疗结果预期和对癌症复发的恐惧） 在第0、2和4周调节RHI和疼痛强度之间的关系;（3）将大脑状态与 在第0周接受RHI的癌症幸存者中通过qEEG测量相对于注意力控制条件， 2和4;和（4）探索在第0，2， 和4.将对参与者进行结构化访谈，以了解与以下方面相关的促进因素和障碍： 在三个时间点进行qEEG。研究结果将用于为更大规模的R 01提供信息。 这一建议的重点与国家护理研究所的战略计划一致 推进症状科学，支持下一代护理科学家的职业发展。

PROJECT SUMMARY/ABSTRACT The proposed K23 award supports the career development of Dr. Linda Eaton into a successful nurse scientist capable of leading multidisciplinary teams in advancing symptom science. Her long-term goal is to improve patient outcomes by developing effective symptom self-management approaches and to understand the biological and psychological mechanisms for these interventions. The initial step is to establish the efficacy of a recorded hypnosis intervention (RHI) for chronic pain reduction. This K23 proposal supports this goal by providing Dr. Eaton with training in (1) team science, (2) biomarkers that predict response to pain management approaches, and (3) further research skills, including mediator-moderator analysis, to evaluate interventions. Dr. Eaton’s primary mentor, Dr. Ardith Doorenbos (nursing), and co-mentors, Dr. Margaret Heitkemper (nursing), and Dr. Mark P. Jensen (rehabilitation), provide expertise in symptom science, team science, biomarker research, and use of hypnosis for pain reduction. The proposed research addresses a critical need to develop safe and effective pain management strategies. Chronic pain affects more than a third of the nearly 16 million cancer survivors in the U.S. Symptom self-management interventions – such as hypnosis – have demonstrated efficacy for many non-cancer chronic pain conditions, seldom have adverse effects, and may be an alternative or complementary approach to pharmacotherapy. However, because of its inconvenience and cost (e.g., the need for multiple appointments with an experienced clinician), hypnosis is rarely used for chronic pain management. The RHI offers an alternative delivery method with the potential to reduce pain with cancer survivors who have completed active treatment and no longer have evidence of disease. The mechanisms of this intervention need to be identified so it can be applied with precision for chronic pain management among cancer survivors. The scientific aims of this randomized control trial will (1) evaluate the efficacy of the RHI in reducing self-reported pain intensity (primary outcome), pain interference, anxiety, depression, fatigue and sleep disturbance (secondary outcomes) at 4 weeks compared to the attention control condition (music recording); (2) examine if psychological factors (hypnotic suggestibility, mental absorption, treatment outcome expectancy, and fear of cancer recurrence) moderate the relationship between RHI and pain intensity at weeks 0, 2, and 4; (3) compare brain states as measured by qEEG in cancer survivors receiving the RHI relative to the attention control condition at weeks 0, 2, and 4; and (4) explore the mediation effects of brain states (theta activity) on pain intensity at weeks 0, 2, and 4. Structured interviews will be conducted with participants to understand facilitators and barriers related to undergoing qEEG at three time points. Findings will be used to inform a larger scale R01. The focus of this proposal is consistent with the strategic plan of the National Institute of Nursing Research to advance symptom science and support the career development of the next generation of nurse scientists.