Breathe-intervention for Hot Flashes, Associated Outcomes, and Interference
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 218
- 试验地点
- 1
- 主要终点
- Hot Flash Frequency
研究概览
简要总结
Background: Paced respiration has been internationally recommended for vasomotor symptom management despite limited empirical evidence.
Objective: To evaluate efficacy of a paced respiration intervention against a sham comparator breathing control and usual care control for vasomotor and other menopausal symptoms.
Design: A 16-week, 3-group, partially blinded, controlled trial with 2:2:1 randomization and stratification by group (breast cancer, no cancer), Midwestern city and surrounding area.
Participants: 218 randomized women (96 breast cancer survivors, 122 menopausal women without cancer) recruited through community mailings and registries.
Interventions: Training, home practice support, and instructions to use the breathing at the time of each hot flash were delivered via compact disc with printed booklet (paced respiration intervention) or digital videodisc with printed booklet (fast shallow breathing control). Usual care control received a letter regarding group assignment.
Main Measures: Hot flash frequency, severity, and bother (primary), hot flash interference in daily life, perceived control over hot flashes, and mood and sleep disturbances (secondary). Intervention performance, adherence, and adverse events were assessed.
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, Outcomes Assessor)
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
- •At least 18 years of age
- •Reporting daily hot flashes and desirous of hot flash treatment
- •Peri- or post menopausal
- •Living within a 60-mile radius of Indianapolis or willing to drive to the center for all study visits
- •Able to read, write, and speak English
- •in good general health
- •In addition:
- •Breast Cancer survivors will have a known diagnosis of non-metastatic disease
- •No history of other cancers
- •Be at least four weeks post-completion of surgery, radiation and chemotherapy
排除标准
- •Known psychiatric disorders or cognitive impairments
- •Participation in our previous pilot study evaluating our control condition
- •Self-reported difficulties with normal everyday breathing
- •Meet criteria at baseline for number of subjective and/or objective hot flashes
研究组 & 干预措施
Paced respiration
The paced respiration intervention group received a compact disc with paper booklet. The booklet reinforced instructions on the first audio track for how to accomplish a target breath rate of 6-8 breaths per minute, practice twice per day for 15 minutes, and apply the breathing at the onset of each hot flash. Women were instructed to do slow, deep, abdominal breathing in through the nose and out through the mouth as per international recommendations (4). They were also instructed to practice twice per day for 15 minutes as per the small, laboratory-based studies (5, 6). The second and third tracks contained specially composed, digitally recorded music to help entrain the breath rate and structure the length of practice.
干预措施: Paced respiration (Behavioral)
Sham comparator: Fast, shallow breathing
The sham comparator group received a digital videodisc with paper booklet. The booklet reinforced voice-over and video demonstration to practice twice per day and apply the fast shallow breathing at the onset of each flash. A previously published report provides additional details and data indicating this program was a suitable attention control.
干预措施: Sham comparator: fast shallow breathing (Behavioral)
Control: Usual Care
The usual care group received an investigator-signed letter explaining they were not selected to receive any study materials during the 16-week follow-up. These participants received paced respiration materials by mail after study completion.
结局指标
主要结局
Hot Flash Frequency
时间窗: 16 weeks
Prospective, real-time electronic diary used by participants for a minimum of 24 hours to a maximum of 7 days. Duration of use was determined by participant choice.
Hot Flash Severity
时间窗: 16 weeks
Self-reported rating using a scale from 0 (not at all severe) to 10 (extremely severe). Calculated as 24 hour averages at 16 week timepoint.
Hot Flash Bother
时间窗: 16 weeks
Self-reported rating using a scale from 0 (not at all bothersome) to 10 (extremely bothersome). Calculated as 24 hour averages at 16 week timepoint.
次要结局
- Hot Flash Related Daily Interference(16 weeks)
- Mood Disturbance(16 weeks)
- Sleep Disturbance(16 weeks)
- Perceived Control Over Hot Flashes(16 weeks)