| Primary | The Difference in Hot Flash Score (Frequency and Severity) Between Baseline (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. | | Posted | | Mean | Standard Deviation | units on a scale | | Week 1 and Week 9 | | | | ID | Title | Description |
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| OG000 | 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 compact disc (CD), for 8 weeks. | | OG001 | 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 compact disc (CD), for 8 weeks. | | OG002 | 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 compact disc (CD), for 8 weeks. |
| | | Title | Denominators | Categories |
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| | | Title | Measurements |
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| - OG000-6.5± 5.38
- OG001-7.5± 8.14
- OG002-6.5± 7.97
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| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
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| Treatment effectiveness was measured using pairwise comparisons of hot flash score change from baseline in each paced breathing arm. | Wilcoxon rank-sum | | 0.3679 | | | | | | | 95 | | | | | | | Superiority or Other | | | | Treatment effectiveness was measured using pairwise comparisons of hot flash score change from baseline in each paced breathing arm. |
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| Secondary | Change From Baseline to Week 9 for PSQI Global Score | The Pittsburgh Sleep Quality Index (PSQI) has 19 items and seven component scales: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep-wake disturbances, use of sleep medication, and daytime dysfunction. The scoring algorithm yields seven component scales on 0-3 scales which are summed to produce a global score on a 0-21 scale with higher values representing more severe sleep difficulty. The global score is translated into 0-100 scale with high values representing best quality of life (QOL). The habitual sleep efficiency component and global score was estimated using the worst-case scenarios for the values that were provided for PSQI question 4. Change from baseline to week 9 was calculated by subtracting the baseline scores from the scores at week 9. | Includes all participants who completed both baseline and week 9 assessments. | Posted | | Median | Full Range | units on a scale | | Baseline and Week 9 | | | | ID | Title | Description |
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| OG000 | 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 compact disc (CD), for 8 weeks. | | OG001 | 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 compact disc (CD), for 8 weeks. |
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| Secondary | Change From Baseline to Week 9 on Blood Pressure Measurement | Participants were taught home monitoring of blood pressure and provided with the sphygmomanometer. The measurements data were recorded on the Blood Pressure Measurement log. Change from baseline to week 9 was calculated by subtracting the baseline measurement from the measurement at week 9. | Includes all participants who had both baseline and week 9 blood pressure measurements. | Posted | | Median | Full Range | mmHg | | Baseline and Week 9 | | | | ID | Title | Description |
|---|
| OG000 | 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 compact disc (CD), for 8 weeks. | | OG001 | 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 compact disc (CD), for 8 weeks. | | OG002 | 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 compact disc (CD), for 8 weeks. |
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| Secondary | Change From Baseline to Week 9 for POMS Total Score and Subscales | Profile of Mood States (POMS) measures a variety of mood states including tension/anxiety, depression/dejection, anger/hostility, vigor/activity, fatigue/inertia and confusion/bewilderment. Each subscale consist of 5 items with a 5 points-scale (0=not at all, 1=a little, 2=moderately, 3=quite a bit and 4=extremely). The subscale scores were the sum of all five items. The total score was the sum of all subscale scores. The scores were then transformed into a 100-point scale with higher numbers indicating best quality of life (QOL). Change from baseline to week 9 was calculated by subtracting the baseline scores from the scores at week 9. | Includes all participants who completed both baseline and week 9 assessments. | Posted | | Mean | Standard Deviation | units on a scale | | Baseline and Week 9 | | | | ID | Title | Description |
|---|
| OG000 | 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 compact disc (CD), for 8 weeks. | | OG001 | 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 compact disc (CD), for 8 weeks. | | OG002 |
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| Secondary | 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 | Profile of Mood States (POMS) measures a variety of mood states including tension/anxiety, depression/dejection, anger/hostility, vigor/activity, fatigue/inertia and confusion/bewilderment. Each subscale consist of 5 items with a 5 points-scale (0=not at all, 1=a little, 2=moderately, 3=quite a bit and 4=extremely). The subscale scores were the sum of all five items. The total score was the sum of all subscale scores. The scores were then transformed into a 100-point scale with higher numbers indicating best quality of life (QOL). Change from baseline to week 9 was calculated by subtracting the baseline scores from the scores at week 9. The correlation was estimated using Pearson correlation coefficients. The assessment of the Pearson Correlation Coefficients was the pre-specified Secondary outcome, and not the underlying changes in the POMS scores. | Includes all participants who completed both baseline and week 9 assessments. | Posted | | Number | | Correlation coefficient | | Baseline and Week 9 | | | | ID | Title | Description |
|---|
| OG000 | 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 compact disc (CD), for 8 weeks. | | OG001 | Paced Breathing (15 Min Twice Daily, 6 Breaths/Min) | |
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| Secondary | Change From Baseline to Week 9 for BFI Fatigue Scores | Brief Fatigue Inventory (BFI) consist of 3 items that assess the severity of fatigue and 6 items that assess the impact of fatigue on daily functioning in a 10-points scale with 0 as no fatigue or does not interfere with daily functioning and 10 as bad fatigue or completely interferes. The scores for the six items were summed up to form a total interference score. The linear analogue scale of fatigue was a 10-points scale with 0 as no fatigue and 10 as bad fatigue. All scores were then transformed into 0 to 100 scale, with 100 as less fatigue/less interference. Change from baseline to week 9 was calculated by subtracting the baseline scores from the scores at week 9. | Includes all participants who completed both baseline and week 9 assessments. | Posted | | Mean | Standard Deviation | units on a scale | | Baseline and Week 9 | | | | ID | Title | Description |
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| OG000 | 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 compact disc (CD), for 8 weeks. | | OG001 | 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 compact disc (CD), for 8 weeks. | | OG002 |
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| Secondary | Pearson Correlation Coefficients for Changes in Hot Flash Scores From Baseline to Week 9 With Changes in BFI Fatigue From Baseline to Week 9 | Brief Fatigue Inventory (BFI) consist of 3 items that assess the severity of fatigue and 6 items that assess the impact of fatigue on daily functioning in a 10-points scale with 0 as no fatigue or does not interfere with daily functioning and 10 as bad fatigue or completely interferes. The scores for the six items were summed up to form a total interference score. The linear analogue scale of fatigue was a 10-points scale with 0 as no fatigue and 10 as bad fatigue. All scores were then transformed into 0 to 100 scale, with 100 as less fatigue/less interference. Change from baseline to week 9 was calculated by subtracting the baseline scores from the scores at week 9. The correlation was estimated using Pearson correlation coefficients. The assessment of the Pearson Correlation Coefficients was the pre-specified Secondary outcome, and not the underlying changes in the BFI fatigue items scores. | Includes all participants who completed both baseline and week 9 assessments. | Posted | | Number | | Correlation coefficient | | Baseline and Week 9 | | | | ID | Title | Description |
|---|
| OG000 | 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 compact disc (CD), for 8 weeks. | | OG001 | Paced Breathing (15 Min Twice Daily, 6 Breaths/Min) | |
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| Secondary | Change From Baseline to Week 9 for Symptom Distress Diary | Symptom Experience Diary is a self-report diary of expected side effects from controlled breathing on 10-points scale with 10 represents symptoms all the time. Individual item scores were then transformed into 0 to 100 scale, with 100 indicates best quality of life (QOL). Change from baseline to week 9 was calculated by subtracting the baseline scores from the scores at week 9. | Includes all participants who completed both baseline and week 9 assessments. | Posted | | Mean | Standard Deviation | units on a scale | | Baseline and Week 9 | | | | ID | Title | Description |
|---|
| OG000 | 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 compact disc (CD), for 8 weeks. | | OG001 | 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 compact disc (CD), for 8 weeks. | | OG002 | 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 compact disc (CD), for 8 weeks. |
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| Secondary | 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 | Symptom Experience Diary is a self-report diary of expected side effects from controlled breathing on 10-points scale with 10 represents symptoms all the time. Individual item scores were then transformed into 0 to 100 scale, with 100 indicates best quality of life (QOL). Change from baseline to week 9 was calculated by subtracting the baseline scores from the scores at week 9. The correlation was estimated using Pearson correlation coefficients. The assessment of the Pearson Correlation Coefficients was the pre-specified Secondary outcome, and not the underlying changes in the Symptom Experience Diary item scores. | Includes all participants who completed both baseline and week 9 assessments. | Posted | | Number | | Correlation coefficient | | Baseline and Week 9 | | | | ID | Title | Description |
|---|
| OG000 | 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 compact disc (CD), for 8 weeks. | | OG001 | 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 compact disc (CD), for 8 weeks. | |
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