Breathe for Hot Flashes Randomized Controlled Trial

Study Overview
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Brief Summary
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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.

Official Title
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Breathe-intervention for Hot Flashes, Associated Outcomes, and Interference

Conditions
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Hot Flashes

Intervention / Treatment
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* Behavioral: Paced respiration
* Behavioral: Sham comparator: fast shallow breathing


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Paced respiration<br>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. | Behavioral: Paced respiration<br>* Breathing exercise<br>|
| Sham Comparator: Sham comparator: Fast, shallow breathing<br>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. | Behavioral: Sham comparator: fast shallow breathing<br>* sham breathing exercise<br>|
| No Intervention: Control: Usual Care<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 16 weeks | 
| 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. | 16 weeks | 
| 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. | 16 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 16 weeks | 
| 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. | 16 weeks | 
| 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. | 16 weeks | 
| 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. | 16 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Menopause, Breast Cancer, Hot Flash, Night Sweats