Breast Cancer, Fatigue, Hot Flashes, Sleep Disorders
Conditions
Keywords
fatigue, sleep disorders, ductal breast carcinoma in situ, lobular breast carcinoma in situ, breast cancer, hot flashes
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALPaced 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.
BEHAVIORALPaced 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.
BEHAVIORALPaced 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.
Sponsors
National Cancer Institute (NCI)
Mayo Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 120 Years
Healthy volunteers
No
Inclusion criteria
DISEASE CHARACTERISTICS: * History of breast cancer including ductal carcinoma in situ or lobular carcinoma in situ \- Treated with surgery and/or adjuvant therapy with a curative intent or patients not preferring to take hormones because of concern for breast cancer * Frequent hot flashes (≥ 14 per week) of sufficient severity to make the patient desire treatment * Presence of hot flashes for ≥ 1 month prior to study entry * Hormone receptor status not specified PATIENT CHARACTERISTICS: * Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 * Pre- or post-menopausal * Must possess a compact disc (CD) player * Able to complete questionnaires alone or with assistance * No active medical conditions preventing compliance with a practice of slow deep breathing including active asthma, chronic obstructive pulmonary disease, or congestive heart failure * No uncontrolled hypertension (defined as systolic blood pressure (BP) ≥ 160 mm Hg and/or diastolic BP ≥ 100 mm Hg on 2 separate visits) PRIOR CONCURRENT THERAPY: * No current (within the past month) practice of yoga or breathing exercises * No other concurrent agents for treating hot flashes (e.g., gabapentin, venlafaxine, paroxetine, citalopram, sertraline, natural products such as soy or sage supplements, flaxseed, or black cohosh) \- Concurrent stable dose antidepressants started within the past 30 days allowed * No concurrent hormonal agents and/or antineoplastic chemotherapy - Tamoxifen, raloxifene, and aromatase inhibitors are allowed if patient has been on a constant dose for ≥ 4 weeks and does not plan to stop the treatment during the course of the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Difference in Hot Flash Score (Frequency and Severity) Between Baseline (Week 1) and Week 9 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline to Week 9 on Blood Pressure Measurement | Baseline and Week 9 | 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. |
| Change From Baseline to Week 9 for POMS Total Score and Subscales | Baseline and 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. |
| 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 | 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. |
| Change From Baseline to Week 9 for PSQI Global Score | Baseline and Week 9 | 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. |
| 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 | 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. |
| Change From Baseline to Week 9 for Symptom Distress Diary | Baseline and 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. |
| 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 | 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. |
| Change From Baseline to Week 9 for BFI Fatigue Scores | Baseline and 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. |
Countries
United States
Participant flow
Recruitment details
One-hundred and five (105) participants were recruited at Mayo Clinic Rochester between 3/08/2007 and 12/8/2009. There were 13 cancelled participants and were excluded from baseline characteristics table.
Pre-assignment details
Participants were evaluated by telephone, or in person, according to the eligibility criteria and educated about the requirements of the study. Eligible and willing women were registered onto the study.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 30 |
| 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. | 31 |
| 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. | 31 |
| Total | 92 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 2 | 1 | 1 |
| Overall Study | Withdrawal by Subject | 7 | 5 | 3 |
Baseline characteristics
| Characteristic | Paced Breathing (15 Min Once Daily, 6 Breaths/Min) | Paced Breathing (15 Min Twice Daily, 6 Breaths/Min) | Paced Breathing (10 Min Once Daily, 14 Breaths/Min) | Total |
|---|---|---|---|---|
| Age, Continuous | 51.3 years STANDARD_DEVIATION 8.4 | 54.4 years STANDARD_DEVIATION 8.1 | 54.5 years STANDARD_DEVIATION 8.7 | 53.4 years STANDARD_DEVIATION 8.5 |
| Age, Customized >=50 years | 15 participants | 23 participants | 22 participants | 60 participants |
| Age, Customized Between 18 and 49 years | 15 participants | 8 participants | 9 participants | 32 participants |
| Average Frequency of Hot Flashes per day >=10 Hot flashes per day | 19 participants | 14 participants | 11 participants | 44 participants |
| Average Frequency of Hot Flashes per day 4-9 Hot flashes per day | 10 participants | 15 participants | 14 participants | 39 participants |
| Average Frequency of Hot Flashes per day <4 Hot flashes per day | 1 participants | 2 participants | 6 participants | 9 participants |
| Breast Cancer History No | 10 participants | 18 participants | 16 participants | 44 participants |
| Breast Cancer History Yes | 20 participants | 13 participants | 15 participants | 48 participants |
| Current tamoxifen, raloxifene, or aromatase inhibitor treatment No | 16 participants | 24 participants | 19 participants | 59 participants |
| Current tamoxifen, raloxifene, or aromatase inhibitor treatment Yes | 14 participants | 7 participants | 12 participants | 33 participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 30 Participants | 31 Participants | 31 Participants | 92 Participants |
| Region of Enrollment United States | 30 participants | 31 participants | 31 participants | 92 participants |
| Sex: Female, Male Female | 30 Participants | 31 Participants | 31 Participants | 92 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 5 / 30 | 7 / 31 | 2 / 31 |
| serious Total, serious adverse events | 0 / 30 | 0 / 31 | 0 / 31 |
Outcome results
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.
Time frame: Week 1 and Week 9
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Paced Breathing (15 Min Once Daily, 6 Breaths/Min) | The Difference in Hot Flash Score (Frequency and Severity) Between Baseline (Week 1) and Week 9 | -6.5 units on a scale | Standard Deviation 5.38 |
| Paced Breathing (15 Min Twice Daily, 6 Breaths/Min) | The Difference in Hot Flash Score (Frequency and Severity) Between Baseline (Week 1) and Week 9 | -7.5 units on a scale | Standard Deviation 8.14 |
| Paced Breathing (10 Min Once Daily, 14 Breaths/Min) | The Difference in Hot Flash Score (Frequency and Severity) Between Baseline (Week 1) and Week 9 | -6.5 units on a scale | Standard Deviation 7.97 |
Comparison: Treatment effectiveness was measured using pairwise comparisons of hot flash score change from baseline in each paced breathing arm.p-value: 0.3679Wilcoxon rank-sum
Comparison: Treatment effectiveness was measured using pairwise comparisons of hot flash score change from baseline in each paced breathing arm.p-value: 0.4715Wilcoxon rank-sum
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.
Time frame: Baseline and Week 9
Population: Includes all participants who completed both baseline and week 9 assessments.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Paced Breathing (15 Min Once Daily, 6 Breaths/Min) | Change From Baseline to Week 9 for BFI Fatigue Scores | Usual Fatigue | 16.3 units on a scale | Standard Deviation 18.6 |
| Paced Breathing (15 Min Once Daily, 6 Breaths/Min) | Change From Baseline to Week 9 for BFI Fatigue Scores | Fatigue Right Now | 8.9 units on a scale | Standard Deviation 25.8 |
| Paced Breathing (15 Min Once Daily, 6 Breaths/Min) | Change From Baseline to Week 9 for BFI Fatigue Scores | Worst Fatigue Last 24 Hours | 12.6 units on a scale | Standard Deviation 32.8 |
| Paced Breathing (15 Min Twice Daily, 6 Breaths/Min) | Change From Baseline to Week 9 for BFI Fatigue Scores | Usual Fatigue | 11.8 units on a scale | Standard Deviation 18.9 |
| Paced Breathing (15 Min Twice Daily, 6 Breaths/Min) | Change From Baseline to Week 9 for BFI Fatigue Scores | Fatigue Right Now | 13.5 units on a scale | Standard Deviation 19.9 |
| Paced Breathing (15 Min Twice Daily, 6 Breaths/Min) | Change From Baseline to Week 9 for BFI Fatigue Scores | Worst Fatigue Last 24 Hours | 18.7 units on a scale | Standard Deviation 23.2 |
| Paced Breathing (10 Min Once Daily, 14 Breaths/Min) | Change From Baseline to Week 9 for BFI Fatigue Scores | Fatigue Right Now | 17.2 units on a scale | Standard Deviation 28.8 |
| Paced Breathing (10 Min Once Daily, 14 Breaths/Min) | Change From Baseline to Week 9 for BFI Fatigue Scores | Worst Fatigue Last 24 Hours | 18.8 units on a scale | Standard Deviation 33.1 |
| Paced Breathing (10 Min Once Daily, 14 Breaths/Min) | Change From Baseline to Week 9 for BFI Fatigue Scores | Usual Fatigue | 12.4 units on a scale | Standard Deviation 25.1 |
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.
Time frame: Baseline and Week 9
Population: Includes all participants who completed both baseline and week 9 assessments.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Paced Breathing (15 Min Once Daily, 6 Breaths/Min) | Change From Baseline to Week 9 for POMS Total Score and Subscales | Tension-Anxiety Subscale | 0 units on a scale | Standard Deviation 16 |
| Paced Breathing (15 Min Once Daily, 6 Breaths/Min) | Change From Baseline to Week 9 for POMS Total Score and Subscales | Fatigue-Inertia Subscale | 8.6 units on a scale | Standard Deviation 19 |
| Paced Breathing (15 Min Once Daily, 6 Breaths/Min) | Change From Baseline to Week 9 for POMS Total Score and Subscales | Confusion-Bewilderment Subscale | 5.6 units on a scale | Standard Deviation 11.2 |
| Paced Breathing (15 Min Once Daily, 6 Breaths/Min) | Change From Baseline to Week 9 for POMS Total Score and Subscales | POMS Total Score | 4.4 units on a scale | Standard Deviation 9.2 |
| Paced Breathing (15 Min Once Daily, 6 Breaths/Min) | Change From Baseline to Week 9 for POMS Total Score and Subscales | Anger-Hostility Subscale | 2.8 units on a scale | Standard Deviation 14.5 |
| Paced Breathing (15 Min Once Daily, 6 Breaths/Min) | Change From Baseline to Week 9 for POMS Total Score and Subscales | Vigor-Activity Subscale | 8.1 units on a scale | Standard Deviation 17.8 |
| Paced Breathing (15 Min Once Daily, 6 Breaths/Min) | Change From Baseline to Week 9 for POMS Total Score and Subscales | Depression-Dejection Subscale | 1.1 units on a scale | Standard Deviation 9.3 |
| Paced Breathing (15 Min Twice Daily, 6 Breaths/Min) | Change From Baseline to Week 9 for POMS Total Score and Subscales | Confusion-Bewilderment Subscale | 5.2 units on a scale | Standard Deviation 9.7 |
| Paced Breathing (15 Min Twice Daily, 6 Breaths/Min) | Change From Baseline to Week 9 for POMS Total Score and Subscales | POMS Total Score | 5.2 units on a scale | Standard Deviation 9.9 |
| Paced Breathing (15 Min Twice Daily, 6 Breaths/Min) | Change From Baseline to Week 9 for POMS Total Score and Subscales | Tension-Anxiety Subscale | 5 units on a scale | Standard Deviation 13.5 |
| Paced Breathing (15 Min Twice Daily, 6 Breaths/Min) | Change From Baseline to Week 9 for POMS Total Score and Subscales | Depression-Dejection Subscale | 3.9 units on a scale | Standard Deviation 13.2 |
| Paced Breathing (15 Min Twice Daily, 6 Breaths/Min) | Change From Baseline to Week 9 for POMS Total Score and Subscales | Fatigue-Inertia Subscale | 12.4 units on a scale | Standard Deviation 20.1 |
| Paced Breathing (15 Min Twice Daily, 6 Breaths/Min) | Change From Baseline to Week 9 for POMS Total Score and Subscales | Vigor-Activity Subscale | 4.3 units on a scale | Standard Deviation 21.5 |
| Paced Breathing (15 Min Twice Daily, 6 Breaths/Min) | Change From Baseline to Week 9 for POMS Total Score and Subscales | Anger-Hostility Subscale | 0.5 units on a scale | Standard Deviation 11.8 |
| Paced Breathing (10 Min Once Daily, 14 Breaths/Min) | Change From Baseline to Week 9 for POMS Total Score and Subscales | Fatigue-Inertia Subscale | 13.8 units on a scale | Standard Deviation 23.3 |
| Paced Breathing (10 Min Once Daily, 14 Breaths/Min) | Change From Baseline to Week 9 for POMS Total Score and Subscales | Tension-Anxiety Subscale | 3 units on a scale | Standard Deviation 20.7 |
| Paced Breathing (10 Min Once Daily, 14 Breaths/Min) | Change From Baseline to Week 9 for POMS Total Score and Subscales | Anger-Hostility Subscale | 1.5 units on a scale | Standard Deviation 18.8 |
| Paced Breathing (10 Min Once Daily, 14 Breaths/Min) | Change From Baseline to Week 9 for POMS Total Score and Subscales | Vigor-Activity Subscale | 4.6 units on a scale | Standard Deviation 17.2 |
| Paced Breathing (10 Min Once Daily, 14 Breaths/Min) | Change From Baseline to Week 9 for POMS Total Score and Subscales | Confusion-Bewilderment Subscale | 0.9 units on a scale | Standard Deviation 8 |
| Paced Breathing (10 Min Once Daily, 14 Breaths/Min) | Change From Baseline to Week 9 for POMS Total Score and Subscales | Depression-Dejection Subscale | -0.6 units on a scale | Standard Deviation 16.6 |
| Paced Breathing (10 Min Once Daily, 14 Breaths/Min) | Change From Baseline to Week 9 for POMS Total Score and Subscales | POMS Total Score | 3.9 units on a scale | Standard Deviation 13.1 |
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.
Time frame: Baseline and Week 9
Population: Includes all participants who completed both baseline and week 9 assessments.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Paced Breathing (15 Min Once Daily, 6 Breaths/Min) | Change From Baseline to Week 9 for PSQI Global Score | 4.8 units on a scale |
| Paced Breathing (15 Min Twice Daily, 6 Breaths/Min) | Change From Baseline to Week 9 for PSQI Global Score | 4.8 units on a scale |
| Paced Breathing (10 Min Once Daily, 14 Breaths/Min) | Change From Baseline to Week 9 for PSQI Global Score | 7.1 units on a scale |
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.
Time frame: Baseline and Week 9
Population: Includes all participants who completed both baseline and week 9 assessments.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Paced Breathing (15 Min Once Daily, 6 Breaths/Min) | Change From Baseline to Week 9 for Symptom Distress Diary | Nervousness | 4.4 units on a scale | Standard Deviation 22.3 |
| Paced Breathing (15 Min Once Daily, 6 Breaths/Min) | Change From Baseline to Week 9 for Symptom Distress Diary | Trouble Sleeping | 18.3 units on a scale | Standard Deviation 30.2 |
| Paced Breathing (15 Min Once Daily, 6 Breaths/Min) | Change From Baseline to Week 9 for Symptom Distress Diary | Fatigue | 15.3 units on a scale | Standard Deviation 30.3 |
| Paced Breathing (15 Min Once Daily, 6 Breaths/Min) | Change From Baseline to Week 9 for Symptom Distress Diary | Negative Mood | 6.1 units on a scale | Standard Deviation 18.5 |
| Paced Breathing (15 Min Once Daily, 6 Breaths/Min) | Change From Baseline to Week 9 for Symptom Distress Diary | Abnormal Sweating | 20.0 units on a scale | Standard Deviation 41.8 |
| Paced Breathing (15 Min Twice Daily, 6 Breaths/Min) | Change From Baseline to Week 9 for Symptom Distress Diary | Abnormal Sweating | 24.6 units on a scale | Standard Deviation 30.2 |
| Paced Breathing (15 Min Twice Daily, 6 Breaths/Min) | Change From Baseline to Week 9 for Symptom Distress Diary | Fatigue | 20.8 units on a scale | Standard Deviation 21 |
| Paced Breathing (15 Min Twice Daily, 6 Breaths/Min) | Change From Baseline to Week 9 for Symptom Distress Diary | Trouble Sleeping | 21.7 units on a scale | Standard Deviation 28.2 |
| Paced Breathing (15 Min Twice Daily, 6 Breaths/Min) | Change From Baseline to Week 9 for Symptom Distress Diary | Nervousness | 4.2 units on a scale | Standard Deviation 17.4 |
| Paced Breathing (15 Min Twice Daily, 6 Breaths/Min) | Change From Baseline to Week 9 for Symptom Distress Diary | Negative Mood | 12.1 units on a scale | Standard Deviation 24 |
| Paced Breathing (10 Min Once Daily, 14 Breaths/Min) | Change From Baseline to Week 9 for Symptom Distress Diary | Negative Mood | 7.8 units on a scale | Standard Deviation 24.4 |
| Paced Breathing (10 Min Once Daily, 14 Breaths/Min) | Change From Baseline to Week 9 for Symptom Distress Diary | Nervousness | 6.3 units on a scale | Standard Deviation 27.9 |
| Paced Breathing (10 Min Once Daily, 14 Breaths/Min) | Change From Baseline to Week 9 for Symptom Distress Diary | Fatigue | 17.2 units on a scale | Standard Deviation 32.2 |
| Paced Breathing (10 Min Once Daily, 14 Breaths/Min) | Change From Baseline to Week 9 for Symptom Distress Diary | Trouble Sleeping | 11.9 units on a scale | Standard Deviation 28 |
| Paced Breathing (10 Min Once Daily, 14 Breaths/Min) | Change From Baseline to Week 9 for Symptom Distress Diary | Abnormal Sweating | 29.2 units on a scale | Standard Deviation 41.1 |
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.
Time frame: Baseline and Week 9
Population: Includes all participants who had both baseline and week 9 blood pressure measurements.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Paced Breathing (15 Min Once Daily, 6 Breaths/Min) | Change From Baseline to Week 9 on Blood Pressure Measurement | Diastolic Blood Pressure Evening | -2.1 mmHg |
| Paced Breathing (15 Min Once Daily, 6 Breaths/Min) | Change From Baseline to Week 9 on Blood Pressure Measurement | Diastolic Blood Pressure Morning | -4.1 mmHg |
| Paced Breathing (15 Min Once Daily, 6 Breaths/Min) | Change From Baseline to Week 9 on Blood Pressure Measurement | Systolic Blood Pressure Morning | 1.0 mmHg |
| Paced Breathing (15 Min Once Daily, 6 Breaths/Min) | Change From Baseline to Week 9 on Blood Pressure Measurement | Systolic Blood Pressure Evening | -0.6 mmHg |
| Paced Breathing (15 Min Twice Daily, 6 Breaths/Min) | Change From Baseline to Week 9 on Blood Pressure Measurement | Systolic Blood Pressure Evening | -3.4 mmHg |
| Paced Breathing (15 Min Twice Daily, 6 Breaths/Min) | Change From Baseline to Week 9 on Blood Pressure Measurement | Systolic Blood Pressure Morning | 0.1 mmHg |
| Paced Breathing (15 Min Twice Daily, 6 Breaths/Min) | Change From Baseline to Week 9 on Blood Pressure Measurement | Diastolic Blood Pressure Morning | -1.9 mmHg |
| Paced Breathing (15 Min Twice Daily, 6 Breaths/Min) | Change From Baseline to Week 9 on Blood Pressure Measurement | Diastolic Blood Pressure Evening | -1.7 mmHg |
| Paced Breathing (10 Min Once Daily, 14 Breaths/Min) | Change From Baseline to Week 9 on Blood Pressure Measurement | Diastolic Blood Pressure Morning | -1.6 mmHg |
| Paced Breathing (10 Min Once Daily, 14 Breaths/Min) | Change From Baseline to Week 9 on Blood Pressure Measurement | Diastolic Blood Pressure Evening | 0.5 mmHg |
| Paced Breathing (10 Min Once Daily, 14 Breaths/Min) | Change From Baseline to Week 9 on Blood Pressure Measurement | Systolic Blood Pressure Morning | -0.4 mmHg |
| Paced Breathing (10 Min Once Daily, 14 Breaths/Min) | Change From Baseline to Week 9 on Blood Pressure Measurement | Systolic Blood Pressure Evening | 2.2 mmHg |
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.
Time frame: Baseline and Week 9
Population: Includes all participants who completed both baseline and week 9 assessments.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Paced Breathing (15 Min Once Daily, 6 Breaths/Min) | Pearson Correlation Coefficients for Changes in Hot Flash Scores From Baseline to Week 9 With Changes in BFI Fatigue From Baseline to Week 9 | Usual Fatigue | 0.13 Correlation coefficient |
| Paced Breathing (15 Min Once Daily, 6 Breaths/Min) | Pearson Correlation Coefficients for Changes in Hot Flash Scores From Baseline to Week 9 With Changes in BFI Fatigue From Baseline to Week 9 | Fatigue Right Now | -0.25 Correlation coefficient |
| Paced Breathing (15 Min Once Daily, 6 Breaths/Min) | Pearson Correlation Coefficients for Changes in Hot Flash Scores From Baseline to Week 9 With Changes in BFI Fatigue From Baseline to Week 9 | Worst Fatigue Last 24 hours | 0.11 Correlation coefficient |
| Paced Breathing (15 Min Twice Daily, 6 Breaths/Min) | Pearson Correlation Coefficients for Changes in Hot Flash Scores From Baseline to Week 9 With Changes in BFI Fatigue From Baseline to Week 9 | Usual Fatigue | 0.06 Correlation coefficient |
| Paced Breathing (15 Min Twice Daily, 6 Breaths/Min) | Pearson Correlation Coefficients for Changes in Hot Flash Scores From Baseline to Week 9 With Changes in BFI Fatigue From Baseline to Week 9 | Fatigue Right Now | -0.20 Correlation coefficient |
| Paced Breathing (15 Min Twice Daily, 6 Breaths/Min) | Pearson Correlation Coefficients for Changes in Hot Flash Scores From Baseline to Week 9 With Changes in BFI Fatigue From Baseline to Week 9 | Worst Fatigue Last 24 hours | -0.36 Correlation coefficient |
| Paced Breathing (10 Min Once Daily, 14 Breaths/Min) | Pearson Correlation Coefficients for Changes in Hot Flash Scores From Baseline to Week 9 With Changes in BFI Fatigue From Baseline to Week 9 | Fatigue Right Now | -0.18 Correlation coefficient |
| Paced Breathing (10 Min Once Daily, 14 Breaths/Min) | Pearson Correlation Coefficients for Changes in Hot Flash Scores From Baseline to Week 9 With Changes in BFI Fatigue From Baseline to Week 9 | Worst Fatigue Last 24 hours | -0.11 Correlation coefficient |
| Paced Breathing (10 Min Once Daily, 14 Breaths/Min) | Pearson Correlation Coefficients for Changes in Hot Flash Scores From Baseline to Week 9 With Changes in BFI Fatigue From Baseline to Week 9 | Usual Fatigue | -0.12 Correlation coefficient |
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.
Time frame: Baseline and Week 9
Population: Includes all participants who completed both baseline and week 9 assessments.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Paced Breathing (15 Min Once Daily, 6 Breaths/Min) | 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 | Tension-Anxiety Subscale | -0.18 Correlation coefficient |
| Paced Breathing (15 Min Once Daily, 6 Breaths/Min) | 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 | Fatigue-Inertia Subscale | 0.32 Correlation coefficient |
| Paced Breathing (15 Min Once Daily, 6 Breaths/Min) | 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 | Confusion-Bewilderment Subscale | 0.21 Correlation coefficient |
| Paced Breathing (15 Min Once Daily, 6 Breaths/Min) | 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 | POMS Total Score | -0.05 Correlation coefficient |
| Paced Breathing (15 Min Once Daily, 6 Breaths/Min) | 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 | Anger-Hostility Subscale | -0.25 Correlation coefficient |
| Paced Breathing (15 Min Once Daily, 6 Breaths/Min) | 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 | Vigor-Activity Subscale | -0.22 Correlation coefficient |
| Paced Breathing (15 Min Once Daily, 6 Breaths/Min) | 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 | Depression-Dejection Subscale | -0.05 Correlation coefficient |
| Paced Breathing (15 Min Twice Daily, 6 Breaths/Min) | 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 | Confusion-Bewilderment Subscale | -0.33 Correlation coefficient |
| Paced Breathing (15 Min Twice Daily, 6 Breaths/Min) | 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 | POMS Total Score | -0.32 Correlation coefficient |
| Paced Breathing (15 Min Twice Daily, 6 Breaths/Min) | 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 | Tension-Anxiety Subscale | -0.36 Correlation coefficient |
| Paced Breathing (15 Min Twice Daily, 6 Breaths/Min) | 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 | Depression-Dejection Subscale | -0.35 Correlation coefficient |
| Paced Breathing (15 Min Twice Daily, 6 Breaths/Min) | 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 | Fatigue-Inertia Subscale | -0.20 Correlation coefficient |
| Paced Breathing (15 Min Twice Daily, 6 Breaths/Min) | 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 | Vigor-Activity Subscale | 0.04 Correlation coefficient |
| Paced Breathing (15 Min Twice Daily, 6 Breaths/Min) | 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 | Anger-Hostility Subscale | -0.25 Correlation coefficient |
| Paced Breathing (10 Min Once Daily, 14 Breaths/Min) | 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 | Fatigue-Inertia Subscale | 0.26 Correlation coefficient |
| Paced Breathing (10 Min Once Daily, 14 Breaths/Min) | 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 | Tension-Anxiety Subscale | 0.19 Correlation coefficient |
| Paced Breathing (10 Min Once Daily, 14 Breaths/Min) | 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 | Anger-Hostility Subscale | 0.21 Correlation coefficient |
| Paced Breathing (10 Min Once Daily, 14 Breaths/Min) | 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 | Vigor-Activity Subscale | 0.01 Correlation coefficient |
| Paced Breathing (10 Min Once Daily, 14 Breaths/Min) | 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 | Confusion-Bewilderment Subscale | 0.37 Correlation coefficient |
| Paced Breathing (10 Min Once Daily, 14 Breaths/Min) | 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 | Depression-Dejection Subscale | 0.35 Correlation coefficient |
| Paced Breathing (10 Min Once Daily, 14 Breaths/Min) | 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 | POMS Total Score | 0.29 Correlation coefficient |
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.
Time frame: Baseline and Week 9
Population: Includes all participants who completed both baseline and week 9 assessments.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Paced Breathing (15 Min Once Daily, 6 Breaths/Min) | 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 | Nervousness | -0.30 Correlation coefficient |
| Paced Breathing (15 Min Once Daily, 6 Breaths/Min) | 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 | Trouble Sleeping | -0.56 Correlation coefficient |
| Paced Breathing (15 Min Once Daily, 6 Breaths/Min) | 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 | Fatigue | -0.24 Correlation coefficient |
| Paced Breathing (15 Min Once Daily, 6 Breaths/Min) | 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 | Abnormal Sweating | -0.43 Correlation coefficient |
| Paced Breathing (15 Min Once Daily, 6 Breaths/Min) | 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 | Negative Mood | -0.19 Correlation coefficient |
| Paced Breathing (15 Min Twice Daily, 6 Breaths/Min) | 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 | Trouble Sleeping | -0.15 Correlation coefficient |
| Paced Breathing (15 Min Twice Daily, 6 Breaths/Min) | 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 | Fatigue | 0.04 Correlation coefficient |
| Paced Breathing (15 Min Twice Daily, 6 Breaths/Min) | 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 | Abnormal Sweating | -0.30 Correlation coefficient |
| Paced Breathing (15 Min Twice Daily, 6 Breaths/Min) | 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 | Nervousness | -0.43 Correlation coefficient |
| Paced Breathing (15 Min Twice Daily, 6 Breaths/Min) | 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 | Negative Mood | 0.05 Correlation coefficient |
| Paced Breathing (10 Min Once Daily, 14 Breaths/Min) | 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 | Negative Mood | 0.21 Correlation coefficient |
| Paced Breathing (10 Min Once Daily, 14 Breaths/Min) | 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 | Nervousness | 0.15 Correlation coefficient |
| Paced Breathing (10 Min Once Daily, 14 Breaths/Min) | 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 | Fatigue | 0.26 Correlation coefficient |
| Paced Breathing (10 Min Once Daily, 14 Breaths/Min) | 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 | Trouble Sleeping | -0.28 Correlation coefficient |
| Paced Breathing (10 Min Once Daily, 14 Breaths/Min) | 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 | Abnormal Sweating | -0.20 Correlation coefficient |