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| ID | Type | Description | Link |
|---|---|---|---|
| R01CA132927 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
| National Cancer Institute (NCI) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Paced respiration | Experimental | 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. |
|
| Sham comparator: Fast, shallow breathing | Sham Comparator | 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. |
|
| Control: Usual Care | No Intervention | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Paced respiration | Behavioral | Breathing exercise |
| |
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 2 weeks |
| Intervention Performance |
Inclusion Criteria:
In addition:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Janet S Carpenter, PhD, RN | Indiana University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Indiana University School of Nursing | Indianapolis | Indiana | 46202 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22936289 | Result | Carpenter JS, Burns DS, Wu J, Otte JL, Schneider B, Ryker K, Tallman E, Yu M. Paced respiration for vasomotor and other menopausal symptoms: a randomized, controlled trial. J Gen Intern Med. 2013 Feb;28(2):193-200. doi: 10.1007/s11606-012-2202-6. |
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De-identified data available upon request.
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| FG002 | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Analysis based on all randomized participants. | Posted | Mean | Standard Deviation | Hot flashes per 24 hr | 16 weeks |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Janet S Carpenter, PhD, RN, FAAN | Indiana University | 317-278-6093 | carpentj@iupui.edu |
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| ID | Term |
|---|---|
| D019584 | Hot Flashes |
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| Sham comparator: fast shallow breathing |
| Behavioral |
sham breathing exercise |
|
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 |
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. |
| 16 weeks |
| Intervention Adherence | Number of breathing practice sessions per participant over the 16 week study period. | 16 weeks |
| BG001 | 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. |
| BG002 | 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. |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Breast Cancer History | Breast cancer survivors > 4 weeks post-completion of surgery, radiation, and/or chemotherapy for nonmetastatic breast cancer with no additional cancer history OR menopausal women with no cancer history | Number | Participants |
|
| 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. | Mean | Standard Deviation | Hot flashes per 24 hr |
|
| Hot Flash Severity | Self-reported rating using a scale from 0 (not at all severe) to 10 (extremely severe). Calculated as 24 hour averages. | Mean | Standard Deviation | Scores on a scale |
|
| Hot Flash Bother | Self-reported rating using a scale from 0 (not at all bothersome) to 10 (extremely bothersome). Calculated as 24 hour averages. | Mean | Standard Deviation | Scores on a scale |
|
| Hot Flash Related Daily Interference | Self-report using well-validated, standardized questionnaire. Subject rated interference items on scale from 0 to 10. Total score range was 0-100 with higher scores indicating greater interference with daily life. | Mean | Standard Deviation | Scores on a scale |
|
| 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. | Mean | Standard Deviation | Scores on a scale |
|
| 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. | Mean | Standard Deviation | Scores on a scale |
|
| 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. | Mean | Standard Deviation | Global sleep quality score |
|
| OG001 | 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. |
| OG002 | 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. |
|
|
| 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. | Analysis based on all randomized participants. | Posted | Mean | Standard Deviation | Scores on a scale | 16 weeks |
|
|
|
| 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. | Analysis based on all randomized participants. | Posted | Mean | Standard Deviation | Scores on a scale | 16 weeks |
|
|
|
| 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. | Posted | Mean | Standard Deviation | Scores on a scale | 16 weeks |
|
|
|
| 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. | Posted | Mean | Standard Deviation | Global Sleep Disturbance Score | 16 weeks |
|
|
|
| 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. | Analysis based on all randomized participants. | Posted | Mean | Standard Deviation | Scores on a scale | 16 weeks |
|
|
|
| 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. | Analysis based on all randomized participants. | Posted | Mean | Standard Deviation | Scores on a scale | 16 weeks |
|
|
|
| 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. | Posted | Mean | Standard Deviation | Breaths Per Minute | 2 weeks |
|
|
|
| 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. | Posted | Mean | Standard Deviation | Breaths Per Minute | 16 weeks |
|
|
|
| Other Pre-specified | Intervention Adherence | Number of breathing practice sessions per participant over the 16 week study period. | Posted | Mean | Standard Deviation | Total practice sessions in 16 weeks | 16 weeks |
|
|
|
| 0 |
| 88 |
| 0 |
| 88 |
| EG001 | 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. | 0 | 86 | 0 | 86 |
| EG002 | 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. | 0 | 44 | 0 | 44 |
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| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |