Hypnosis for Hot Flashes in Breast Cancer Survivors

描述(由申请人提供)： 背景：潮热对许多乳腺癌幸存者来说是一个严重的问题。事实上，78%的女性化疗接受者和72%的三苯氧胺接受者会出现潮热。据报道，绝大多数乳腺癌幸存者都有严重的潮热。此外，潮热会导致不适、睡眠中断、焦虑和生活质量下降。对于绝经前或绝经后卵巢衰竭和潮热的治疗，对于没有乳腺癌病史的女性来说，一直是雌激素替代疗法。然而，雌激素与乳腺癌风险的增加有关，因此对于乳腺癌幸存者来说通常是避免的。此外，由于这一担忧，许多女性拒绝雌激素。鉴于这些事实，开发新的干预措施来帮助经历潮热的乳腺癌幸存者是当务之急。一种耐受性良好且有效的治疗潮热的心身疗法将是非常有价值的。我们已经确定了催眠的一种创新用途，这可能有助于降低乳腺癌幸存者潮热的频率和严重程度。据我们所知，到目前为止，还没有研究调查催眠对潮热的作用。 目的：我们的远期目标是提高护理质量，减轻乳腺癌患者的痛苦。这项提案的目标是进行一项试点研究，以评估创新使用催眠减少乳腺癌幸存者潮热的效果。这项提案是实现我们长期目标的下一步。该提案的中心假设是，这种干预将导致乳腺癌幸存者潮热的显着减少。 具体目标：我们希望通过追求两个具体目标来检验我们的中心假设，并实现这项先导研究的目标：(1)确定催眠在减少乳腺癌幸存者潮热方面的有效性。我们的工作假设是，催眠干预将导致潮热的频率和严重程度显著降低。(2)确定催眠性与催眠干预成功相关的程度。我们假设，那些测量到的催眠能力较高的个体将通过催眠干预获得更好的结果。 设计、设置和参与者：我们将招募60名有潮热症状的女性乳腺癌幸存者。 参与者将被随机分配到催眠治疗组或不接受治疗的对照组。治疗组的参与者将接受5次单独的潮热催眠治疗。我们将测量干预前后潮热的频率、严重程度和影响。这项研究将在斯科特和怀特诊所和医院(德克萨斯州A&M大学系统医学院的515内科设施和临床教学园区)内进行。 主要观察指标：受试者将完成潮热频率和严重程度的日常对话。此外，参与者将每周记录潮热的影响。主要结果将是潮热的频率和严重程度。我们还将确定催眠性与结果相关的程度。次要结果将是焦虑、抑郁、睡眠和性功能的测量。

DESCRIPTION (provided by applicant): Context: Hot flashes are a significant problem for many breast cancer survivors. In fact, 78% of female chemotherapy recipients and 72% of tamoxifen recipients experience hot flashes. Severe hot flashes are reported by a large majority of breast cancer survivors with hot flashes. Further, hot flashes results in discomfort, disrupted sleep, anxiety, and decreased quality of life. The treatment of ovarian failure and hot flashes occurring either premenopausally or postmenopausally has been estrogen replacement therapy for women with no history of breast cancer. However, estrogens have been associated with increased risk of breast cancer and therefore are often avoided for breast cancer survivors. Also, because of this concern many women reject estrogens. Given these facts it is imperative that new interventions be developed to help breast cancer survivors who experience hot flashes. A well-tolerated and effective mind-body treatment for hot flashes would be of great value. We have identified an innovative use of hypnosis that may be of benefit in reducing the frequency and severity of hot flashes in breast cancer survivors. To our knowledge, no studies to date have investigated the use of hypnosis for hot flashes. Objective: Our/long-range goal is to improve the quality of care and relieve suffering among breast cancer patients. The objective of this proposal, which is the next step in attaining our long-range goal, is to conduct a pilot study to evaluate the effect of an innovative use of hypnosis to reduce hot flashes in breast cancer survivors. The central hypothesis of the proposal is that this intervention will result in a significant reduction in hot flashes in breast cancer survivors. Specific Aims: We expect to test our central hypothesis and achieve the objective of this pilot study by pursuing two specific aims: (1) Determine the efficacy of hypnosis in reducing hot flashes in breast cancer survivors. Our working hypothesis is that the hypnosis intervention will result in significant reductions in the frequency and severity of hot flashes. (2) Determine the extent to which hypnotizability is related to the success of the hypnotherapy intervention. We hypothesize that individuals who are higher in their measured hypnotizability will achieve better results with the hypnosis intervention. Design, Setting, and Participants: We will enroll 60 female breast cancer survivors with hot flashes. Participants will be randomly assigned to either a hypnosis treatment group or no-treatment control. Participants in the treatment group will receive 5 individual sessions of hypnosis for hot flashes. We will measure the frequency, severity and impact of hot flashes pre- and post-intervention. The study will be conducted within Scott and White Clinic and Hospital (a 515 physician facility and clinical teaching campus for the Texas A&M University System College of Medicine). Main Outcome Measures: Participants will complete daily dialries of the frequency and severity of hot flashes. Also, participants will record the impact of hot flashes on a weekly basis. The primary outcome will be frequency and severity of hot flashes. We will also determine the extent to which hypnotizability is related to outcomes. Secondary outcomes will be measures of anxiety, depression, sleep, and sexual functioning.