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

项目摘要/摘要 拟议的K23奖项支持琳达·伊顿医生的职业发展成为一名成功的护士 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和了解 这些干预的生物和心理机制。最初的步骤是建立 有记录的催眠干预(RHI)对慢性疼痛减轻的疗效。 这项K23提案通过为伊顿博士提供(1)团队科学、(2)团队科学方面的培训来支持这一目标。 预测疼痛管理方法反应的生物标记物，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)，以及共同导师玛格丽特·海特肯珀博士(护理)和马克·P·延森博士(康复)，提供 在症状科学、团队科学、生物标记物研究和催眠用于减轻疼痛方面的专业知识。 拟议的研究满足了开发安全和有效的疼痛管理的迫切需要 战略。慢性疼痛影响到美国近1600万癌症幸存者中的三分之一以上。 自我管理干预--如催眠--已证明对许多非癌症慢性疾病有效 疼痛状况，很少有不良影响，可能是一种替代或补充方法 药物疗法。然而，由于其不便和费用(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的治疗。RHI提供了一种 替代分娩方法，有可能减轻已完成活动的癌症幸存者的疼痛 治疗，不再有疾病的证据。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。的科学目标 这项随机对照试验将(1)评估RHI在降低自我报告的疼痛强度方面的效果 (主要结果)、疼痛干扰、焦虑、抑郁、疲劳和睡眠障碍(次要结果) 在4周时比较注意控制条件(音乐录音)；(2)检查是否有心理因素 (催眠暗示、精神吸收、治疗结果预期和对癌症复发的恐惧) 在第0周、第2周和第4周缓和RHI与疼痛强度的关系；(3)比较大脑状态如下 在接受RHI治疗的癌症幸存者在0周时相对于注意力控制情况进行qEEG测量， 2和4；以及(4)探讨大脑状态(theta活动)在0、2、 4.将与参与者进行结构化访谈，以了解与以下方面相关的促进者和障碍 在三个时间点进行QEEG检查。结果将被用来为更大规模的R01提供信息。 这项建议的重点与国家护理研究所的战略规划一致 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.