Presurgery Hypnosis in Breast Cancer: Benefits Analysis

描述(申请人提供)：在2003年被诊断为乳腺癌的211,300名妇女中，超过90%的人将接受手术作为其治疗的一部分。尽管药物管理有所改进，但全身麻醉下的外科手术仍然与临床上显著的副作用有关，其中最主要的是疼痛和恶心。这些临床问题在乳腺癌手术治疗后尤为严重，可能需要额外的药物干预，延长恢复室停留时间，推迟出院，并导致意外的再入院。对其他患者群体的临床研究表明，术前催眠可以减少术中并发症，减少术后症状，并促进康复。乳房手术患者的初步数据显示，与注意力控制条件相比，与心理学家一起进行短暂的术前催眠可以显著改善术后的恢复。然而，还需要正式审查的是，是否需要由专业人士进行“现场”干预：在将其转化为日常临床实践之前，一个关键问题可以完成。此外，干预可能会带来长期的“附带好处”。这项研究的目标是确定“活的”和有记录的术前催眠干预在乳房切除术患者中的相对有效性和成本。研究创新包括调查调节剂和调节剂对不同群体效应的影响，以及对手术后12个月干预的副作用进行探索。这一原始研究提案的结果将对临床应用和科学理解都有帮助。研究的具体目的是：1)调查“现场”催眠干预措施对计划接受乳腺癌手术的妇女的有益影响；2)检查催眠干预措施的潜在调节变量对乳腺癌手术后副作用及康复的影响；3)确定催眠干预措施的益处是否由术前认知期望和情绪困扰的差异来解释(调节)；4)调查催眠干预措施对面临乳腺癌及其治疗的妇女有副作用的可能性。为达到上述目的，125例乳腺癌根治术患者随机分为5组。两组在手术日干预(3级：“实时”催眠阶段；记录催眠阶段；对照组)和催眠练习时段(2级：是；无对照-豁免)上存在差异，以确定“实时”、记录和练习阶段的术前催眠在减少副作用和促进康复方面的相对贡献。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解者和调节者(例如，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.