Prediction and Prevention of Persistent Post-Mastectomy Pain

乳房切除术后持续疼痛的预测和预防

• 批准号: 8821992
• 负责人: KRISTIN SCHREIBER
• 金额: $ 19.59万
• 依托单位: BRIGHAM AND WOMEN'S HOSPITAL
• 依托单位国家: 美国
• 财政年份: 2015
• 资助国家: 美国
• 起止时间: 2015-01-15 至 2018-12-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8821992
• 关键词: Achievement; Affect; Animal Model; Anxiety; Biometry; Cancer Center; Characteristics; Chronic; Clinical; Clinical Trials; Data; Detection; Development; Doctor of Philosophy; Effectiveness of Interventions; Enrollment; Future; Health Personnel; High Risk Woman; Individual; Individual Differences; Intervention; Intervention Trial; Investigation; Ketamine; Mastectomy; Medical; Mental Depression; Mentored Patient-Oriented Research Career Development Award; Mentors; Mentorship; Modeling; Nature; Nociception; Noise; Operative Surgical Procedures; Pain; Pain Threshold; Patient risk; Patients; Perioperative; Persons; Pharmaceutical Preparations; Pharmacy (field); Physiology; Placebos; Play; Postoperative Pain; Pre-Clinical Model; Preemptive Analgesia; Prevention; Preventive; Process; Process Measure; Prospective Studies; Psychology; Psychophysics; Psychosocial Factor; Radiation therapy; Research Infrastructure; Research Personnel; Retrospective Studies; Risk; Risk Factors; Role; Sensory; Signal Transduction; Sleep disturbances; Societies; Solutions; Stimulus; Syndrome; Testing; Therapeutic Trials; Training; Translations; Treatment Factor; Woman; Work; aging population; base; career; career development; chemotherapy; chronic pain; cohort; cost; design; high risk; improved; indexing; malignant breast neoplasm; novel; pre-clinical; pressure; prevent; psychologic; psychosocial; public health relevance; screening; skills; statistics; success; surgical pain; therapeutic effectiveness; tool

DESCRIPTION (provided by applicant): Chronic pain is devastating both to individuals and society. In an aging population, surgery is an increasing cause of chronic pain, with rates of persistent post-operative pain ranging from 10-65%. In particular, Persistent Post-Mastectomy Pain (PPMP) occurs in roughly one third of women who have had mastectomy. The occurrence of PPMP does not seem to be strongly determined by the type of surgery, chemotherapy, and radiation treatment, suggesting that individual person-specific factors may play a more important role. In fact, recent studies by the candidate indicate that individual differences in pain sensitiity (psychophysics) are more closely associated with PPMP than surgical/medical variables. Specifically, sensory testing revealed that women who developed PPMP had lower pressure pain thresholds and greater temporal summation of pain stimuli than women who did not develop this chronic pain condition. Moreover, psychosocial factors such as anxiety, depression, catastrophizing, and somatization were more prominent in women with PPMP. These preliminary, retrospective studies suggest that individual psychophysical and psychosocial characteristics could be important risk factors for PPMP. Accordingly, the first Aim of this study is to comprehensively and prospectively study women having mastectomy surgery, to determine the relationship between pre-operative psychophysical and psychosocial factors and the development of PPMP. The second Aim is to develop a prediction model for PPMP using the data collected in Aim 1, thus allowing a preoperative calculation of a "PPMP risk score" for any patient facing mastectomy. This will then be validated in a separate group of patients (study 2). Study will be this risk score will be used to enrich an interventional trial with a greater proporton of women at high risk of PPMP, with Aim 3 to investigate whether this enrichment allows more efficient and sensitive determination of a preventative drug's effect than in an unscreened group. These studies will lay the groundwork to efficiently test novel pharmaceutics only in the high risk patients who need them. The candidate in this application, Dr. Kristin Schreiber is a PhD-trained Neuroscientist and Anesthesiologist at a leading academic, high-volume breast cancer center. The proposed studies would inform healthcare providers about the underlying mechanisms contributing to chronic pain after surgery, thus allowing more targeted, preventive treatment in patients who are high risk for persisting post-operative pain. Her career development mentors are experts in surgical, medical, psychological, and preoperative assessment, preclinical modeling, and biostatistics. The candidate's strong scientific background, taken together with the proposed formal training in advanced statistics and diverse mentorship, in a center that has a strong tradition and infrastructure for clinical trials, will enure the successful achievement of her scientific and career objectives to prevent PPMP and lay the groundwork for prevention of other persistent post-surgical pain syndromes.

描述（由申请人提供）：慢性疼痛对个人和社会都是毁灭性的。在老龄化人口中，手术越来越成为慢性疼痛的原因，术后持续疼痛的发生率在 10-65% 之间。特别是，大约三分之一接受乳房切除术的女性会出现持续性乳房切除术后疼痛 (PPMP)。 PPMP 的发生似乎并没有很大程度上取决于手术、化疗和放射治疗的类型，这表明个体因素可能发挥更重要的作用。事实上，候选人最近的研究表明，与手术/医疗变量相比，疼痛敏感性（心理物理学）的个体差异与 PPMP 的关系更为密切。具体来说，感觉测试显示，与未患这种慢性疼痛的女性相比，患有 PPMP 的女性压力痛阈值较低，疼痛刺激的时间总和更大。此外，焦虑、抑郁、灾难化和躯体化等心理社会因素在患有 PPMP 的女性中更为突出。这些初步回顾性研究表明，个人心理物理和心理社会特征可能是 PPMP 的重要危险因素。因此，本研究的首要目的是全面、前瞻性地研究接受乳房切除手术的女性，以确定术前心理物理和心理社会因素与 PPMP 发生之间的关系。第二个目标是使用目标 1 中收集的数据开发 PPMP 预测模型，从而允许对任何面临乳房切除术的患者进行术前计算“PPMP 风险评分”。然后将在另一组患者中验证这一点（研究 2）。研究将使用该风险评分来丰富一项干预性试验，该试验涉及更大比例的 PPMP 高风险女性，目标 3 是调查这种丰富是否能够比未经筛选的组更有效、更灵敏地确定预防药物的效果。这些研究将为仅在需要新药物的高风险患者中有效测试新药物奠定基础。本申请中的候选人克里斯汀·施赖伯 (Kristin Schreiber) 博士是一位接受过博士学位的神经科学家和麻醉师，供职于一家领先的学术性大容量乳腺癌中心。拟议的研究将告知医疗保健提供者有关手术后慢性疼痛的潜在机制，从而为术后持续疼痛高风险的患者提供更有针对性的预防性治疗。她的职业发展导师是外科、医学、心理和术前评估、临床前建模和生物统计学方面的专家。候选人强大的科学背景，加上拟议的高级统计正式培训和多样化的指导，在一个拥有强大临床试验传统和基础设施的中心，将确保她成功实现预防 PPMP 的科学和职业目标，并为预防其他持续性术后疼痛综合征奠定基础。