Evaluation of a Biobehavioral Intervention for Hot Flashes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 71
- 试验地点
- 1
- 主要终点
- Hot flash frequency measured by hot flash diary data
研究概览
简要总结
Rationale: Venlafaxine may help relieve hot flashes in women who have had breast cancer. Hypnosis or focused attention may help control hot flashes in postmenopausal women. It is not yet known whether giving venlafaxine together with hypnosis or focused attention is more effective in treating hot flashes.
Purpose: This randomized clinical trial is studying venlafaxine together with hypnosis or focused attention in treating patients with hot flashes.
详细描述
Objectives:
I. To evaluate the effect of hypnosis plus venlafaxine versus focused attention with venlafaxine versus hypnosis plus a placebo versus focused attention plus a placebo for reducing hot flashes.
II. To evaluate the side effects associated with hypnosis with venlafaxine versus focused attention with venlafaxine versus hypnosis plus a placebo versus focused attention plus a placebo for reducing hot flashes.
III. To evaluate the effects of the four treatment arms on mood, sleep, hot flash interference and menopause quality of life.
IV. To explore the role of expectancy and hypnotizability as moderators of the effect of each of the four treatment arms in reducing hot flashes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Arm I
Patients receive oral venlafaxine once or twice daily in weeks 2-8. Patients see a therapist once a week to learn hypnosis in weeks 2-5. Patients continue hypnosis at home in weeks 6-8.
干预措施: venlafaxine (Drug)
Arm I
Patients receive oral venlafaxine once or twice daily in weeks 2-8. Patients see a therapist once a week to learn hypnosis in weeks 2-5. Patients continue hypnosis at home in weeks 6-8.
干预措施: hypnotherapy (Procedure)
Arm II
Patients receive oral venlafaxine once or twice daily in weeks 2-8. Patients see a therapist once a week to learn focused attention in weeks 2-5. Patients continue focused attention at home in weeks 6-8.
干预措施: venlafaxine (Drug)
Arm II
Patients receive oral venlafaxine once or twice daily in weeks 2-8. Patients see a therapist once a week to learn focused attention in weeks 2-5. Patients continue focused attention at home in weeks 6-8.
干预措施: mind-body intervention procedure (Procedure)
Arm III
Patients receive oral placebo once or twice daily in weeks 2-8. Patient see a therapist once a week to learn hypnosis in weeks 2-5. Patients continue hypnosis at home in weeks 6-8.
干预措施: placebo (Drug)
Arm III
Patients receive oral placebo once or twice daily in weeks 2-8. Patient see a therapist once a week to learn hypnosis in weeks 2-5. Patients continue hypnosis at home in weeks 6-8.
干预措施: hypnotherapy (Procedure)
Arm IV
Patients receive oral placebo once or twice daily in weeks 2-8. Patient see a therapist once a week to learn focused attention in weeks 2-5. Patients continue focused attention at home in weeks 6-8.
干预措施: placebo (Drug)
Arm IV
Patients receive oral placebo once or twice daily in weeks 2-8. Patient see a therapist once a week to learn focused attention in weeks 2-5. Patients continue focused attention at home in weeks 6-8.
干预措施: mind-body intervention procedure (Procedure)
结局指标
主要结局
Hot flash frequency measured by hot flash diary data
时间窗: Daily during study, weeks 2-8
Hot flash score measured by hot flash diary data
时间窗: Daily during study, weeks 2-8
Hot flash severity measured by hot flash diary data
时间窗: Daily during study, weeks 2-8
次要结局
- Sleep effects measured by Modified Medical Outcomes Sleep Scale questionnaire(Week 8)
- Mood measured by Profile of Mood States questionnaire(Week 8)
- Evaluate the moderating effect of the expectations for the intervention to be effective and the ability of the person to be hypnotized(Week 5)
- Side effects measured by CTCAE v 3.0 and patient reports(Once a week, weeks 2-8)
- Menopause quality of life measured by MENQOL questionnaire(Week 8)
- Daily interference measured by Hot Flash Related Daily Interference Scale questionnaire(Week 8)