Trial Outcomes & Findings for Breathe for Hot Flashes Randomized Controlled Trial (NCT NCT00819182)

NCT ID: NCT00819182

Last Updated: 2016-03-24

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 218 participants
• Primary outcome timeframe: 16 weeks
• Results posted on: 2016-03-24

Participant Flow

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.

Participant milestones

Measure	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.	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.	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.
Overall Study STARTED	88	86	44
Overall Study Week 16 Visit	75	78	43
Overall Study COMPLETED	75	78	43
Overall Study NOT COMPLETED	13	8	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Breathe for Hot Flashes Randomized Controlled Trial

Baseline characteristics by cohort

Measure	Paced Respiration n=88 Participants 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.	Fast, Shallow Breathing n=86 Participants 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.	Usual Care n=44 Participants 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.	Total n=218 Participants Total of all reporting groups
Age, Continuous	53.44 years STANDARD_DEVIATION 6.84 • n=5 Participants	51.93 years STANDARD_DEVIATION 6.81 • n=7 Participants	53.52 years STANDARD_DEVIATION 5.68 • n=5 Participants	52.86 years STANDARD_DEVIATION 6.62 • n=4 Participants
Sex: Female, Male Female	88 Participants n=5 Participants	86 Participants n=7 Participants	44 Participants n=5 Participants	218 Participants n=4 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	3 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	3 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	85 Participants n=5 Participants	86 Participants n=7 Participants	44 Participants n=5 Participants	215 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Black or African American	23 Participants n=5 Participants	21 Participants n=7 Participants	12 Participants n=5 Participants	56 Participants n=4 Participants
Race (NIH/OMB) White	61 Participants n=5 Participants	62 Participants n=7 Participants	32 Participants n=5 Participants	155 Participants n=4 Participants
Race (NIH/OMB) More than one race	2 Participants n=5 Participants	3 Participants n=7 Participants	0 Participants n=5 Participants	5 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Region of Enrollment United States	88 participants n=5 Participants	86 participants n=7 Participants	44 participants n=5 Participants	218 participants n=4 Participants
Breast Cancer History Breast Cancer Survivor	38 Participants n=5 Participants	38 Participants n=7 Participants	20 Participants n=5 Participants	96 Participants n=4 Participants
Breast Cancer History Menopausal Women with No Cancer History	50 Participants n=5 Participants	48 Participants n=7 Participants	24 Participants n=5 Participants	122 Participants n=4 Participants
Hot Flash Frequency	7.02 Hot flashes per 24 hr STANDARD_DEVIATION 4.32 • n=5 Participants	6.43 Hot flashes per 24 hr STANDARD_DEVIATION 3.96 • n=7 Participants	7.31 Hot flashes per 24 hr STANDARD_DEVIATION 4.04 • n=5 Participants	6.84 Hot flashes per 24 hr STANDARD_DEVIATION 4.12 • n=4 Participants
Hot Flash Severity	4.50 Scores on a scale STANDARD_DEVIATION 1.60 • n=5 Participants	5.23 Scores on a scale STANDARD_DEVIATION 1.58 • n=7 Participants	5.40 Scores on a scale STANDARD_DEVIATION 1.26 • n=5 Participants	5.17 Scores on a scale STANDARD_DEVIATION 1.53 • n=4 Participants
Hot Flash Bother	4.52 Scores on a scale STANDARD_DEVIATION 1.72 • n=5 Participants	4.78 Scores on a scale STANDARD_DEVIATION 1.72 • n=7 Participants	4.69 Scores on a scale STANDARD_DEVIATION 1.32 • n=5 Participants	4.66 Scores on a scale STANDARD_DEVIATION 1.64 • n=4 Participants
Hot Flash Related Daily Interference	3.99 Scores on a scale STANDARD_DEVIATION 2.35 • n=5 Participants	4.58 Scores on a scale STANDARD_DEVIATION 2.46 • n=7 Participants	4.51 Scores on a scale STANDARD_DEVIATION 2.61 • n=5 Participants	4.32 Scores on a scale STANDARD_DEVIATION 2.43 • n=4 Participants
Perceived Control Over Hot Flashes	37.38 Scores on a scale STANDARD_DEVIATION 4.68 • n=5 Participants	37.48 Scores on a scale STANDARD_DEVIATION 5.10 • n=7 Participants	37.95 Scores on a scale STANDARD_DEVIATION 4.64 • n=5 Participants	37.57 Scores on a scale STANDARD_DEVIATION 4.80 • n=4 Participants
Mood Disturbance	40.08 Scores on a scale STANDARD_DEVIATION 24.77 • n=5 Participants	47.17 Scores on a scale STANDARD_DEVIATION 23.03 • n=7 Participants	39.50 Scores on a scale STANDARD_DEVIATION 24.47 • n=5 Participants	43.03 Scores on a scale STANDARD_DEVIATION 23.86 • n=4 Participants
Sleep Disturbance	7.38 Global sleep quality score STANDARD_DEVIATION 3.23 • n=5 Participants	8.59 Global sleep quality score STANDARD_DEVIATION 3.59 • n=7 Participants	8.14 Global sleep quality score STANDARD_DEVIATION 3.66 • n=5 Participants	7.99 Global sleep quality score STANDARD_DEVIATION 3.50 • n=4 Participants

PRIMARY outcome

Timeframe: 16 weeks

Population: Analysis based on all randomized participants.

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.

Outcome measures

Measure	Paced Respiration n=88 Participants 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.	Fast, Shallow Breathing n=86 Participants 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.	Usual Care n=44 Participants 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.
Hot Flash Frequency	3.48 Hot flashes per 24 hr Standard Deviation 3.45	3.95 Hot flashes per 24 hr Standard Deviation 4.19	4.76 Hot flashes per 24 hr Standard Deviation 3.54

PRIMARY outcome

Timeframe: 16 weeks

Population: Analysis based on all randomized participants.

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.

Outcome measures

Measure	Paced Respiration n=88 Participants 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.	Fast, Shallow Breathing n=86 Participants 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.	Usual Care n=44 Participants 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.
Hot Flash Severity	4.33 Scores on a scale Standard Deviation 2.06	4.65 Scores on a scale Standard Deviation 2.07	5.20 Scores on a scale Standard Deviation 1.89

PRIMARY outcome

Timeframe: 16 weeks

Population: Analysis based on all randomized participants.

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.

Outcome measures

Measure	Paced Respiration n=88 Participants 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.	Fast, Shallow Breathing n=86 Participants 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.	Usual Care n=44 Participants 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.
Hot Flash Bother	3.89 Scores on a scale Standard Deviation 1.93	4.22 Scores on a scale Standard Deviation 2.19	4.76 Scores on a scale Standard Deviation 1.73

SECONDARY outcome

Timeframe: 16 weeks

Population: Analysis based on all randomized participants.

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.

Outcome measures

Measure	Paced Respiration n=88 Participants 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.	Fast, Shallow Breathing n=86 Participants 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.	Usual Care n=44 Participants 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.
Hot Flash Related Daily Interference	2.75 Scores on a scale Standard Deviation 2.19	3.41 Scores on a scale Standard Deviation 2.54	3.93 Scores on a scale Standard Deviation 2.15

SECONDARY outcome

Timeframe: 16 weeks

Population: Analysis based on all randomized participants.

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.

Outcome measures

Measure	Paced Respiration n=88 Participants 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.	Fast, Shallow Breathing n=86 Participants 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.	Usual Care n=44 Participants 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.
Perceived Control Over Hot Flashes	42.67 Scores on a scale Standard Deviation 4.51	42.69 Scores on a scale Standard Deviation 5.69	39.60 Scores on a scale Standard Deviation 4.73

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Paced Respiration n=88 Participants 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.	Fast, Shallow Breathing n=86 Participants 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.	Usual Care n=44 Participants 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.
Mood Disturbance	38.26 Scores on a scale Standard Deviation 25.79	40.13 Scores on a scale Standard Deviation 20.32	43.48 Scores on a scale Standard Deviation 30.37

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Paced Respiration n=88 Participants 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.	Fast, Shallow Breathing n=86 Participants 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.	Usual Care n=44 Participants 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.
Sleep Disturbance	6.81 Global Sleep Disturbance Score Standard Deviation 3.37	7.66 Global Sleep Disturbance Score Standard Deviation 3.15	8.23 Global Sleep Disturbance Score Standard Deviation 3.82

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

Outcome measures

Measure	Paced Respiration n=88 Participants 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.	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.	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.
Intervention Performance	7.35 Breaths Per Minute Standard Deviation 2.45	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: 16 weeks

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.

Outcome measures

Measure	Paced Respiration n=88 Participants 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.	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.	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.
Intervention Performance	6.97 Breaths Per Minute Standard Deviation 1.92	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: 16 weeks

Number of breathing practice sessions per participant over the 16 week study period.

Outcome measures

Measure	Paced Respiration n=88 Participants 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.	Fast, Shallow Breathing n=86 Participants 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.	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.
Intervention Adherence	109.83 Total practice sessions in 16 weeks Standard Deviation 67.76	133.93 Total practice sessions in 16 weeks Standard Deviation 78.27	—

Adverse Events

Paced Respiration

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Fast, Shallow Breathing

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Usual Care

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Janet S Carpenter, PhD, RN, FAAN

Indiana University

Phone: 317-278-6093

Email: carpentj@iupui.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place