Presurgery Hypnosis in Breast Cancer: Benefits Analysis

描述（由申请人提供）：在2003年被诊断患有乳腺癌的211,300名妇女中，超过90%的人将接受手术治疗，作为其治疗的一部分。尽管药物管理有所改善，全麻下的外科手术仍然与临床显著的副作用相关，其中主要是疼痛和恶心。这些临床问题在乳腺癌手术治疗后尤其严重，可能需要额外的药物干预，延长康复室的时间，延迟出院，并导致意外的再入院。与其他患者人群的临床研究表明，手术前催眠减少术中并发症，术后症状，并提高恢复。乳房手术患者的初步数据显示，在心理学家的指导下进行短暂的手术前催眠，相对于注意力控制状况，可以显著改善术后恢复。然而，需要正式审查的是专业人员的“现场”干预：在转化为日常临床实践之前，这是一个关键问题。此外，这种干预可能有长期的“副作用”。本研究的目的是确定“活体”和记录术前催眠干预在乳房切除术患者中的相对疗效和成本。研究创新包括调查调节因子和中介因子对差异组效应的影响，以及探索手术后12个月干预的副作用。这项原始研究计划的结果将对临床应用和科学理解都有影响。具体目的是：1)调查“现场”和记录的术前催眠干预对乳腺癌手术妇女的有益影响；2)探讨催眠干预的潜在调节变量对术后不良反应和恢复的影响；3)确定催眠干预的有益效果是否可以通过术前认知期望和情绪困扰的差异来解释（介导）；4)探讨催眠干预对乳腺癌患者及其治疗是否有副作用。为了达到这些目的，125名乳腺癌乳房切除术患者将被随机分为5组。各组在手术日干预（3个级别：“现场”催眠阶段；记录催眠阶段；对照组）和催眠练习期（2个级别：有；没有-对照组豁免）上不同，以确定“现场”、“记录”和练习期手术催眠对减少副作用和促进恢复的相对贡献。该设计允许在随机临床试验中直接比较这些干预措施的临床影响和成本效益。将确定催眠效果的调节因子和调节因子（如可催眠性），以及干预的长期副作用。

DESCRIPTION (provided by applicant): Over 90% of the 211,300 women diagnosed with breast cancer in 2003 will undergo surgery as part of their curative treatment. Despite improvements in pharmacological management, surgical procedures under general anesthesia continue to be associated with clinically significant side effects, chief among which are pain and nausea. These clinical problems are particularly severe following surgical treatment for breast cancer and can require additional pharmacologic intervention, prolong recovery room stay, delay discharge, and lead to unanticipated readmission. Clinical research with other patient populations has indicated that presurgery hypnosis reduces intraoperative complications, postoperative symptoms, and enhances recovery. Preliminary data with breast surgery patients has revealed that a brief presurgery hypnosis with a psychologist can significantly improve post-surgery recovery relative to an attention control condition. Yet to be formally examined is the need for a "live" intervention by a professional: a critical question before translation to everyday clinical practice can be accomplished. Furthermore, the intervention may have long term "side benefits." The study goal is to establish the relative efficacy and cost of "live" and recorded presurgical hypnosis interventions in mastectomy patients. Study innovations include investigation of the effects of moderators and mediators on the differential group effects, as well as an exploration of the side benefits of the intervention for 12 months following surgery. The results of this original research proposal will speak to both clinical application and scientific understanding. The Specific Aims, are to: 1) Investigate the beneficial impact of "live" and recorded presurgical hypnosis interventions in women scheduled for breast cancer surgery; 2) Examine the effects of potential moderating variables of the hypnosis interventions on post-surgery side effects and recovery; 3) Determine whether the beneficial effects of the hypnosis intervention are accounted for (mediated) by differences in presurgery cognitive expectations and emotional distress; and 4) Investigate the possibility that the hypnosis intervention has side benefits for women facing breast cancer and its treatment. To achieve these Aims, 125 breast cancer mastectomy patients will be randomly assigned to 5 Groups. Groups differ on Surgery Day intervention (3 levels: "live" hypnosis session; recorded hypnosis session; control) and Hypnosis Practice Period (2 levels: Yes; No - Controls exempted) to determine the relative contributions of "live," recorded, and practice period presurgery hypnosis to reducing side effects and enhancing recovery. The design allows direct comparisons of both clinical impact and cost effectiveness of these interventions in a randomized clinical trial. Mediators and moderators (e.g., hypnotizability) of hypnosis effects will be determined, as well as long-term side benefits of the intervention.