Hypnosis for Hot Flashes in Breast Cancer Survivors

催眠治疗乳腺癌幸存者潮热

• 批准号: 7107475
• 负责人: Gary R Elkins
• 金额: $ 2.46万
• 依托单位: SCOTT AND WHITE MEMORIAL HOSPITAL
• 依托单位国家: 美国
• 财政年份: 2004
• 资助国家: 美国
• 起止时间: 2004-04-02 至 2007-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7107475
• 关键词: alternative medicine; anxiety; behavioral /social science research tag; breast neoplasms; clinical research; depression; female; hot flash; human subject; human therapy evaluation; hypnosis; libido; long term survivor; patient oriented research; psychotherapy; quality of life; sleep; women' s health

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.

描述（由申请人提供）： 背景：对于许多乳腺癌幸存者来说，潮热是一个重要的问题。实际上，有78％的女性化学疗法接受者和72％的他莫昔芬接受者经历了潮热。据报道，许多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。对没有乳腺癌史的女性，对卵巢衰竭和绝经后发生的卵巢衰竭和潮热是雌激素替代疗法。但是，雌激素与乳腺癌的风险增加有关，因此通常避免乳腺癌幸存者。另外，由于这种关注，许多妇女拒绝雌激素。鉴于这些事实，必须采取新的干预措施来帮助经历潮热的乳腺癌幸存者。对潮热的耐受性良好且有效的心身治疗将具有很大的价值。我们已经确定了催眠的创新使用，这可能在降低乳腺癌幸存者中潮热的频率和严重程度方面有益。据我们所知，迄今为止尚无研究调查催眠对潮热的使用。 目的：我们/远程目标是提高乳腺癌患者的护理质量和缓解痛苦。该提案的目的是实现我们的远程目标的下一步，是进行一项试点研究，以评估催眠的创新使用以减少乳腺癌幸存者中的炎热闪光的影响。该提案的中心假设是，这种干预措施将显着降低乳腺癌幸存者的炎热。 具体目的：我们希望通过追求两个具体目的来检验我们的中心假设，并实现这项试验研究的目标：（1）确定催眠在减少乳腺癌幸存者中炎热闪光方面的功效。我们的工作假设是，催眠干预将导致热闪光的频率和严重程度显着降低。 （2）确定催眠率与催眠疗法干预成功有关的程度。我们假设在催眠干预措施下，催眠性较高的个体将获得更好的结果。 设计，设置和参与者：我们将招募60个具有潮热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无治疗控制。 治疗组的参与者将获得5个单独的催眠疗法，以进行潮热。我们将测量干预前和干预后热潮的频率，严重性和影响。该研究将在斯科特和白人诊所和医院内进行（德克萨斯A＆M大学医学院的515个医师设施和临床教学校园）。 主要结果指标：参与者将每天完成有关潮热的频率和严重性的拨号。此外，参与者将每周记录潮热的影响。主要结果将是热潮的频率和严重性。我们还将确定催眠率与结局有关的程度。次要结果将是焦虑，抑郁，睡眠和性功能的度量。