Hot Flashes
Conditions
Keywords
Menopause, Breast Cancer, Hot Flash, Night Sweats
Brief summary
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.
Interventions
BEHAVIORALPaced respiration
Breathing exercise
BEHAVIORALSham comparator: fast shallow breathing
sham breathing exercise
Sponsors
National Institutes of Health (NIH)
National Cancer Institute (NCI)
Indiana University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hot Flash Severity | 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 | 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. |
| Hot Flash Frequency | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Sleep Disturbance | 16 weeks | Self-report using the Pittsburgh Sleep Quality Index which is composed of 19-items to assess sleep quality and disturbances during the past week. Scores range from 0-21 with higher scores indicating poorer sleep quality and more sleep disturbance. |
| Mood Disturbance | 16 weeks | Self-report using the well-validated Profile of Mood States-Short Form questionnaire. Six subscales are computed. Total scores are computed using the formula Depression-Dejection + Tension-Anxiety + Anger-Hostility + Fatigue-Inertia + Confusion-Bewilderment + (24 - Vigor-Activity). Total scores range from 0 to 124 with higher scores indicating higher mood disturbance. |
| Hot Flash Related Daily Interference | 16 weeks | Self-report using well-validated, standardized questionnaire. Subject rated interference on scale items from 0 to 10. Total score range was 0-100 with higher scores indicating greater interference with daily life. |
| Perceived Control Over Hot Flashes | 16 weeks | Self-report using well-validated, standardized questionnaire composed of 15 items with response option ratings of 1-4. Scores were summed with potential range of 15-60. Lower scores indicated less control over hot flashes; higher scores indicate higher perceived control over hot flashes. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Intervention Performance | 2 weeks | Physiological recordings of number of breaths per minute to verify correct performance of paced respiration for this participant group only. Assessment was conducted in a single visit scheduled 2 weeks post-randomization for the paced respiration group. |
| Intervention Adherence | 16 weeks | Number of breathing practice sessions per participant over the 16 week study period. |
Countries
United States
Participant flow
Recruitment details
Recruitment occurred from April 1, 2009 to February 1, 2011. Participants were recruited by mass mailings to community-dwelling women and registry participants. Additionally, recruitment occurred in breast cancer and high-risk clinics in the Midwest.
Participants by arm
| Arm | Count |
|---|---|
| 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. They were also instructed to practice twice per day for 15 minutes as per the small, laboratory-based studies. The second and third tracks contained specially composed, digitally recorded music to help entrain the breath rate and structure the length of practice. | 88 |
| Fast, Shallow Breathing The fast, shallow 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. | 86 |
| 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. | 44 |
| Total | 218 |
Baseline characteristics
| Characteristic | Paced Respiration | Fast, Shallow Breathing | Total | Usual Care |
|---|---|---|---|---|
| Age, Continuous | 53.44 years STANDARD_DEVIATION 6.84 | 51.93 years STANDARD_DEVIATION 6.81 | 52.86 years STANDARD_DEVIATION 6.62 | 53.52 years STANDARD_DEVIATION 5.68 |
| Breast Cancer History Breast Cancer Survivor | 38 Participants | 38 Participants | 96 Participants | 20 Participants |
| Breast Cancer History Menopausal Women with No Cancer History | 50 Participants | 48 Participants | 122 Participants | 24 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants | 0 Participants | 3 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 85 Participants | 86 Participants | 215 Participants | 44 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Hot Flash Bother | 4.52 Scores on a scale STANDARD_DEVIATION 1.72 | 4.78 Scores on a scale STANDARD_DEVIATION 1.72 | 4.66 Scores on a scale STANDARD_DEVIATION 1.64 | 4.69 Scores on a scale STANDARD_DEVIATION 1.32 |
| Hot Flash Frequency | 7.02 Hot flashes per 24 hr STANDARD_DEVIATION 4.32 | 6.43 Hot flashes per 24 hr STANDARD_DEVIATION 3.96 | 6.84 Hot flashes per 24 hr STANDARD_DEVIATION 4.12 | 7.31 Hot flashes per 24 hr STANDARD_DEVIATION 4.04 |
| Hot Flash Related Daily Interference | 3.99 Scores on a scale STANDARD_DEVIATION 2.35 | 4.58 Scores on a scale STANDARD_DEVIATION 2.46 | 4.32 Scores on a scale STANDARD_DEVIATION 2.43 | 4.51 Scores on a scale STANDARD_DEVIATION 2.61 |
| Hot Flash Severity | 4.50 Scores on a scale STANDARD_DEVIATION 1.6 | 5.23 Scores on a scale STANDARD_DEVIATION 1.58 | 5.17 Scores on a scale STANDARD_DEVIATION 1.53 | 5.40 Scores on a scale STANDARD_DEVIATION 1.26 |
| Mood Disturbance | 40.08 Scores on a scale STANDARD_DEVIATION 24.77 | 47.17 Scores on a scale STANDARD_DEVIATION 23.03 | 43.03 Scores on a scale STANDARD_DEVIATION 23.86 | 39.50 Scores on a scale STANDARD_DEVIATION 24.47 |
| Perceived Control Over Hot Flashes | 37.38 Scores on a scale STANDARD_DEVIATION 4.68 | 37.48 Scores on a scale STANDARD_DEVIATION 5.1 | 37.57 Scores on a scale STANDARD_DEVIATION 4.8 | 37.95 Scores on a scale STANDARD_DEVIATION 4.64 |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 0 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 0 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 23 Participants | 21 Participants | 56 Participants | 12 Participants |
| Race (NIH/OMB) More than one race | 2 Participants | 3 Participants | 5 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 | 61 Participants | 62 Participants | 155 Participants | 32 Participants |
| Region of Enrollment United States | 88 participants | 86 participants | 218 participants | 44 participants |
| Sex: Female, Male Female | 88 Participants | 86 Participants | 218 Participants | 44 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Sleep Disturbance | 7.38 Global sleep quality score STANDARD_DEVIATION 3.23 | 8.59 Global sleep quality score STANDARD_DEVIATION 3.59 | 7.99 Global sleep quality score STANDARD_DEVIATION 3.5 | 8.14 Global sleep quality score STANDARD_DEVIATION 3.66 |
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 | 0 / 88 | 0 / 86 | 0 / 44 |
| serious Total, serious adverse events | 0 / 88 | 0 / 86 | 0 / 44 |
Outcome results
Primary
Hot Flash Bother
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.
Time frame: 16 weeks
Population: Analysis based on all randomized participants.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Paced Respiration | Hot Flash Bother | 3.89 Scores on a scale | Standard Deviation 1.93 |
| Fast, Shallow Breathing | Hot Flash Bother | 4.22 Scores on a scale | Standard Deviation 2.19 |
| Usual Care | Hot Flash Bother | 4.76 Scores on a scale | Standard Deviation 1.73 |
Primary
Hot Flash Frequency
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.
Time frame: 16 weeks
Population: Analysis based on all randomized participants.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Paced Respiration | Hot Flash Frequency | 3.48 Hot flashes per 24 hr | Standard Deviation 3.45 |
| Fast, Shallow Breathing | Hot Flash Frequency | 3.95 Hot flashes per 24 hr | Standard Deviation 4.19 |
| Usual Care | Hot Flash Frequency | 4.76 Hot flashes per 24 hr | Standard Deviation 3.54 |
Primary
Hot Flash Severity
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.
Time frame: 16 weeks
Population: Analysis based on all randomized participants.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Paced Respiration | Hot Flash Severity | 4.33 Scores on a scale | Standard Deviation 2.06 |
| Fast, Shallow Breathing | Hot Flash Severity | 4.65 Scores on a scale | Standard Deviation 2.07 |
| Usual Care | Hot Flash Severity | 5.20 Scores on a scale | Standard Deviation 1.89 |
Secondary
Hot Flash Related Daily Interference
Self-report using well-validated, standardized questionnaire. Subject rated interference on scale items from 0 to 10. Total score range was 0-100 with higher scores indicating greater interference with daily life.
Time frame: 16 weeks
Population: Analysis based on all randomized participants.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Paced Respiration | Hot Flash Related Daily Interference | 2.75 Scores on a scale | Standard Deviation 2.19 |
| Fast, Shallow Breathing | Hot Flash Related Daily Interference | 3.41 Scores on a scale | Standard Deviation 2.54 |
| Usual Care | Hot Flash Related Daily Interference | 3.93 Scores on a scale | Standard Deviation 2.15 |
Secondary
Mood Disturbance
Self-report using the well-validated Profile of Mood States-Short Form questionnaire. Six subscales are computed. Total scores are computed using the formula Depression-Dejection + Tension-Anxiety + Anger-Hostility + Fatigue-Inertia + Confusion-Bewilderment + (24 - Vigor-Activity). Total scores range from 0 to 124 with higher scores indicating higher mood disturbance.
Time frame: 16 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Paced Respiration | Mood Disturbance | 38.26 Scores on a scale | Standard Deviation 25.79 |
| Fast, Shallow Breathing | Mood Disturbance | 40.13 Scores on a scale | Standard Deviation 20.32 |
| Usual Care | Mood Disturbance | 43.48 Scores on a scale | Standard Deviation 30.37 |
Secondary
Perceived Control Over Hot Flashes
Self-report using well-validated, standardized questionnaire composed of 15 items with response option ratings of 1-4. Scores were summed with potential range of 15-60. Lower scores indicated less control over hot flashes; higher scores indicate higher perceived control over hot flashes.
Time frame: 16 weeks
Population: Analysis based on all randomized participants.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Paced Respiration | Perceived Control Over Hot Flashes | 42.67 Scores on a scale | Standard Deviation 4.51 |
| Fast, Shallow Breathing | Perceived Control Over Hot Flashes | 42.69 Scores on a scale | Standard Deviation 5.69 |
| Usual Care | Perceived Control Over Hot Flashes | 39.60 Scores on a scale | Standard Deviation 4.73 |
Secondary
Sleep Disturbance
Self-report using the Pittsburgh Sleep Quality Index which is composed of 19-items to assess sleep quality and disturbances during the past week. Scores range from 0-21 with higher scores indicating poorer sleep quality and more sleep disturbance.
Time frame: 16 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Paced Respiration | Sleep Disturbance | 6.81 Global Sleep Disturbance Score | Standard Deviation 3.37 |
| Fast, Shallow Breathing | Sleep Disturbance | 7.66 Global Sleep Disturbance Score | Standard Deviation 3.15 |
| Usual Care | Sleep Disturbance | 8.23 Global Sleep Disturbance Score | Standard Deviation 3.82 |
Other Pre-specified
Intervention Adherence
Number of breathing practice sessions per participant over the 16 week study period.
Time frame: 16 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Paced Respiration | Intervention Adherence | 109.83 Total practice sessions in 16 weeks | Standard Deviation 67.76 |
| Fast, Shallow Breathing | Intervention Adherence | 133.93 Total practice sessions in 16 weeks | Standard Deviation 78.27 |
Other Pre-specified
Intervention Performance
Physiological recordings of number of breaths per minute to verify correct performance of paced respiration for this participant group only. Assessment was conducted in a single visit scheduled 2 weeks post-randomization for the paced respiration group.
Time frame: 2 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Paced Respiration | Intervention Performance | 7.35 Breaths Per Minute | Standard Deviation 2.45 |
Other Pre-specified
Intervention Performance
Physiological recordings of number of breaths per minute to verify correct performance of paced respiration for this participant group only. Assessment was conducted at the week 16 post-randomization timepoint.
Time frame: 16 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Paced Respiration | Intervention Performance | 6.97 Breaths Per Minute | Standard Deviation 1.92 |