Expectancy and Chemotherapy-Induced Nausea

预期和化疗引起的恶心

• 批准号: 8849376
• 负责人: JOSEPH A ROSCOE
• 金额: $ 56.91万
• 依托单位: UNIVERSITY OF ROCHESTER
• 依托单位国家: 美国
• 财政年份: 2012
• 资助国家: 美国
• 起止时间: 2012-09-01 至 2016-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8849376
• 关键词: Accounting; Acupressure; Age; Antiemetics; Breast Cancer Patient; Cancer Patient; Caregivers; Chemotherapy-Oncologic Procedure; Clinical; Communication; Control Groups; Development; Devices; Double-Blind Method; Doxorubicin; Effectiveness; Emotional; Expectancy; Family; Friends; Fright; Gender; Health Professional; Hospitals; Intervention; Methods; Motion Sickness; Multicenter Studies; Music; Nausea; Outcome; Patient-Centered Care; Patients; Pharmaceutical Preparations; Pilot Projects; Placebo Effect; Play; Predictive Factor; Predisposition; Pregnancy; Process; Psyche structure; Randomized; Randomized Controlled Trials; Regimen; Relaxation; Research; Risk Factors; Role; Site; Source; Suggestion; Testing; Time; Treatment outcome; Work; arm; base; chemotherapeutic agent; chemotherapy; cost; design; expectation; experience; patient expectation; response; therapy design; treatment planning

Nausea remains a significant clinical problem despite the use of the best available antiemetic medications. Several studies have shown that expectations of developing nausea are a significant determinant of whether patients actually develop treatment-induced nausea. For example, we found that breast cancer patients (N = 194) about to begin their first chemotherapy regimen containing doxorubicin who believed that they were "very likely" to experience severe nausea were five times more likely to experience severe nausea than those who believed that they were "very unlikely" to do so. In addition, studies have shown that expectations of efficacy are largely responsible for the placebo effect and for many of the benefits derived from some CAM therapies. For example, in a multicenter study (N = 465) examining acupressure wristbands for control of chemotherapy-induced nausea, we found that patients who expected the bands to be effective in nausea control experienced significantly less nausea than patients who did not expect them to be effective. As a test of whether the effectiveness of acupressure bands in reducing nausea could be enhanced by boosting patients' expectations of the bands' efficacy, we conducted a double-blind, randomized R21 pilot study examining the efficacy of acupressure bands with and without expectancy-enhancing supplementary materials in breast cancer patients beginning chemotherapy. Patients were stratified by expected nausea (high, low). Patients in the active condition received a handout with expectancy-enhancing materials and a 12-minute relaxation CD that included a 30-second "suggestion" concerning the acupressure bands' effectiveness. Patients in the control group received a handout that had only neutral materials concerning the bands' likely effectiveness and a relaxation CD that was identical to the active one except additional music was substituted for the 30-second suggestion concerning the bands' effectiveness. For the 26 patients expecting nausea, peak nausea on the 1-7 scale was an average of 1.2 points less in the patients randomized to the active condition of expectancy enhancing supplementary materials compared to the control condition with neutral supplementary materials; this represents a large effect size of 0.78 (Cohen's D). The present study seeks to confirm and extend these findings in a multi-site, 3-arm, randomized, controlled study of 216 breast cancer patients beginning chemotherapy who expect to have nausea. All patients will receive a standardized antiemetic regimen. Arm 1: Neutral handout; Arm 2: Neutral handout + control relaxation MP3 + acupressure bands; Arm 3: Active handout + active relaxation MP3 + acupressure bands. We hypothesize that acupressure bands provided with efficacy-enhancing materials will be more effective in controlling chemotherapy-induced nausea than acupressure bands provided with neutral materials. We build upon a successful R21 study that was designed to refine methods and provide an effect size estimate for this application.

尽管使用了最佳可用抗过敏药物，但恶心仍然是一个重大的临床问题。几项研究表明，患恶心的期望是患者是否真正发展为治疗引起的恶心的重要决定因素。例如，我们发现乳腺癌患者（n = 194）即将开始他们的第一种化疗方案，其中含有阿霉素的患者，他们认为他们“非常有可能”经历严重恶心的恶心五倍，比那些相信那些相信那些认为的恶心的可能性要高五倍。他们“不太可能”这样做。此外，研究表明，对安慰剂效应的期望和对某些CAM疗法的许多益处在很大程度上是造成的。例如，在一项多中心研究（n = 465）中，检查能力用于控制化疗引起的恶心的呼能腕带，我们发现那些期望这些乐队在恶心控制中有效的患者比没有期望他们会成为他们的恶心患者的恶心要少得多。有效的。为了测试穴带在减少恶心的有效性是否可以通过提高患者对乐队的疗效的期望来增强，我们进行了一项双盲，随机的R21飞行员研究，研究了有和没有预期增强性增强型的振荡带的功效乳腺癌患者的补充材料开始化疗。患者通过预期的恶心（高，低）分层。处于活跃状态的患者接受了带有预期材料的讲义和12分钟的松弛CD，其中包括有关穴带的有效性的30秒“建议”。对照组的患者收到的讲义仅具有有关乐队可能有效性的中性材料和与主动音乐相同的松弛CD，除了其他音乐外，还代替了有关频段有效性的30秒建议。对于预期恶心的26例患者，与具有中性补充材料的对照条件相比，随机分配到预期增强补充材料的主动状态的患者中，患者的峰值恶心平均减少了1.2点；这表示大小为0.78（Cohen's D）。本研究旨在在216名乳腺癌患者开始预期恶心的乳腺癌患者中确认和扩展这些发现。所有患者都将接受标准化的抗抗病治疗方案。手臂1：中性讲义；手臂2：中性讲义 +控制松弛mp3 +穴带；手臂3：主动讲义 +主动放松mp3 +穴带。我们假设提供了具有功效增强材料的穴带在控制化学疗法引起的恶心方面比提供中性材料的穴带更有效。我们基于一项成功的R21研究，该研究旨在完善方法并为此应用提供效果尺寸估计。