Paced Breathing for Hot Flashes: A Randomized Phase II Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 105
- 试验地点
- 2
- 主要终点
- The Difference in Hot Flash Score (Frequency and Severity) Between Baseline (Week 1) and Week 9
研究概览
简要总结
RATIONALE: Paced breathing may be an effective way to reduce the number and severity of hot flashes in women who have survived breast cancer.
PURPOSE: This randomized phase II trial is comparing three different programs of paced breathing to see how well they work in treating hot flashes in women.
详细描述
OBJECTIVES:
- To assess feasibility and obtain initial estimates of efficacy of three different programs of paced breathing (15 minutes once a day at 6 breaths/minute vs 15 minutes twice a day at 6 breaths/minute vs 10 minutes once a day at 14 breaths/minute) on the frequency and severity of hot flashes in breast cancer survivors or patients not preferring to take hormones because of concern for breast cancer.
- To assess feasibility and obtain initial estimates of efficacy of three different programs of paced breathing on mood states, fatigue, sleep quality, and blood pressure measurement in breast cancer survivors or patients not preferring to take hormones because of concern for breast cancer.
OUTLINE: Patients are stratified by age (18-49 vs ≥ 50), frequency of hot flashes per day (< 4 vs 4-9 vs ≥ 10), and current tamoxifen, raloxifene, or aromatase inhibitor treatment (yes vs no). Patients are randomized to 1 of 3 treatment arms.
- Arm I: Patients practice paced breathing for 15 minutes once daily, 6 breaths/min, 5-7 days weekly, following an instructional compact disc (CD), for 8 weeks.
- Arm II: Patients practice paced breathing for 15 minutes twice daily, 6 breaths/min, 5-7 days weekly, following an instructional CD, for 8 weeks.
- Arm III: Patients practice paced breathing for 10 minutes once daily, 14 breaths /min, 5-7 days weekly, following an instructional CD, for 8 weeks.
All patients complete daily hot flash diaries, keep a blood pressure log, and complete the following questionnaires: Symptom Experience Diary, Profile of Mood States, Brief Fatigue Inventory, and Pittsburgh Sleep Quality Index.
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
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 120 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Paced breathing (15 min once daily, 6 breaths/min)
Patients practice paced breathing for 15 minutes once daily, 6 breaths/min, 5-7 days weekly, following an instructional CD, for 8 weeks.
干预措施: Paced breathing (15 min once daily, 6 breaths/min) (Behavioral)
Paced breathing (15 min twice daily, 6 breaths/min)
Patients practice paced breathing for 15 minutes twice daily, 6 breaths/min, 5-7 days weekly, following an instructional CD, for 8 weeks.
干预措施: Paced breathing (15 min twice daily, 6 breaths/min) (Behavioral)
Paced breathing (10 min once daily, 14 breaths/min)
Patients practice paced breathing for 10 minutes once daily, 14 breaths /min, 5-7 days weekly, following an instructional CD, for 8 weeks.
干预措施: Paced breathing (10 min once daily, 14 breaths/min) (Behavioral)
结局指标
主要结局
The Difference in Hot Flash Score (Frequency and Severity) Between Baseline (Week 1) and Week 9
时间窗: Week 1 and Week 9
Hot flash severity were graded from 1 to 4, as they range from mild, moderate, severe, or very severe. A hot flash score is defined by multiplying the daily frequency with the average hot flash severity. These scores are aggregated into average weekly hot flash activity scores for each patient.
次要结局
- Change From Baseline to Week 9 on Blood Pressure Measurement(Baseline and Week 9)
- Change From Baseline to Week 9 for POMS Total Score and Subscales(Baseline and Week 9)
- Pearson Correlation Coefficients for Changes in Hot Flash Scores From Baseline to Week 9 With Changes in POMS Total Score and Subscales From Baseline to Week 9(Baseline and Week 9)
- Change From Baseline to Week 9 for PSQI Global Score(Baseline and Week 9)
- Change From Baseline to Week 9 for BFI Fatigue Scores(Baseline and Week 9)
- Change From Baseline to Week 9 for Symptom Distress Diary(Baseline and Week 9)
- Pearson Correlation Coefficients for Changes in Hot Flash Scores From Baseline to Week 9 With Changes in BFI Fatigue From Baseline to Week 9(Baseline and Week 9)
- Pearson Correlation Coefficients for Changes in Hot Flash Scores From Baseline to Week 9 With Changes in Symptom Experience Diary From Baseline to Week 9(Baseline and Week 9)