NCT00094133Unknown不适用
Hypnosis for Hot Flashes in Breast Cancer Survivors
Scott and White Hospital & Clinic2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2006年4月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Hot flash control by Hot Flash Daily Diary in week 6
研究概览
简要总结
RATIONALE: Hypnosis may be effective in decreasing hot flashes in breast cancer survivors.
PURPOSE: This randomized clinical trial is studying how well hypnosis works in treating hot flashes in breast cancer survivors.
详细描述
OBJECTIVES:
- Determine the efficacy of hypnosis in controlling hot flashes in women who are breast cancer survivors.
- Determine the extent to which hypnotizability is related to the success of the hypnotherapy intervention.
OUTLINE: This is a randomized, controlled study. Patients are stratified according to age, gender, race, and educational background. All patients complete a Hot Flash Daily Diary to record frequency and severity of hot flashes for 1 week. Patients are then randomized to 1 of 2 treatment arms.
- Arm I (hypnotherapy): Patients undergo hypnotherapy once a week for 5 weeks. Patients complete the Hot Flash-Related Daily Interference Scale, the Hospital Depression and Anxiety Sub-scale, the CES Depression Scale, and the MOS-Sleep and Sexual Function Scales in week 5 after the last hypnotherapy intervention. Patients also complete another Hot Flash Daily Diary for 1 week in week 6 and are administered the Stanford Hypnotic Clinical Scale in week 7.
- Arm II (control): Patients receive no contact for 4 weeks. Patients complete the questionnaires as in arm I in week 5. Patients also complete another Hot Flash Daily Diary for 1 week in week 6 and are administered the Stanford Hypnotic Clinical Scale in week 7.
PROJECTED ACCRUAL: A total of 60 patients will be accrued for this study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 主要目的
- Supportive Care
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •History of primary breast cancer
- •No evidence of detectable disease
- •At least 14 hot flashes per week for ≥ 1 month by self-reporting
- •Hormone receptor status not specified
- •PATIENT CHARACTERISTICS:
- •Life expectancy > 6 months
- •Menopausal status not specified
- •Outpatient status
- •No medical or psychiatric condition that would preclude study participation
- •PRIOR CONCURRENT THERAPY:
- •Concurrent antihormonal agents for breast cancer (e.g., tamoxifen or raloxifene) allowed provided the patient has been on them for ≥ 1 month
- •No other concurrent hormonal therapy
- •No other putative therapies for hot flashes ≥ 1 month prior to study entry
- •Concurrent vitamin E allowed
- •No other concurrent treatment for hot flashes
- •No concurrent cytotoxic chemotherapy
- •Not concurrently using hypnosis for any reason
排除标准
- 未提供
结局指标
主要结局
Hot flash control by Hot Flash Daily Diary in week 6
次要结局
未报告次要终点
研究者
研究点 (2)
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