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：潮热是许多乳腺癌幸存者的一个重要问题。事实上，78%的女性化疗接受者和72%的他莫昔芬接受者会出现潮热。严重的潮热是由绝大多数乳腺癌幸存者报告的潮热。此外，潮热导致不适、睡眠中断、焦虑和生活质量下降。对于无乳腺癌病史的女性，绝经前或绝经后发生的卵巢功能衰竭和潮热的治疗一直是雌激素替代疗法。然而，雌激素与乳腺癌风险增加有关，因此乳腺癌幸存者通常避免使用雌激素。此外，由于这种担心，许多妇女拒绝雌激素。鉴于这些事实，迫切需要开发新的干预措施来帮助经历潮热的乳腺癌幸存者。一个耐受性良好和有效的身心治疗潮热将是非常有价值的。我们已经确定了一种创新的催眠方法，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，迄今为止还没有研究调查过催眠对潮热的作用。 目的：我们的长期目标是提高护理质量，减轻乳腺癌患者的痛苦。该提案的目的是实现我们的长期目标的下一步，是进行一项试点研究，以评估催眠的创新使用对减少乳腺癌幸存者潮热的影响。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：我们希望通过以下两个具体目标来验证我们的中心假设并实现本初步研究的目标：（1）确定催眠在减少乳腺癌幸存者潮热中的功效。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着降低。(2)确定催眠能力在多大程度上与催眠治疗干预的成功相关。我们假设，那些被测得的催眠能力较高的人在催眠干预中会取得更好的结果。 设计，设置和参与者：我们将招募60名女性乳腺癌幸存者与潮热。 参与者将被随机分配到催眠治疗组或无治疗对照组。 治疗组的参与者将接受5次单独的催眠治疗潮热。我们将测量干预前后潮热的频率、严重程度和影响。该研究将在Scott和白色诊所和医院（德克萨斯A&M大学系统医学院的515名医生设施和临床教学校园）内进行。 主要结果测量：受试者将完成潮热频率和严重程度的每日日志。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。