Hot FlashesNCT00819182
Breathe for Hot Flashes Randomized Controlled Trial
A study testing Paced respiration in people with Hot Flashes, run by Indiana University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Hot Flashes
- What is being tested?
- Paced respiration
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 218 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2008to Feb 2013
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Show all 10Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Indiana University School of Nursing
Indianapolis, Indiana, 46202
About this study
Official title: Breathe-intervention for Hot Flashes, Associated Outcomes, and Interference
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.
Read more
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.
- Conditions
- Hot Flashes
- Being tested
- Paced respiration, Sham comparator: fast shallow breathing
- Keywords
- Menopause, Breast Cancer, Hot Flash, Night Sweats
- Medical subject headings
- Hot Flashes, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Paced respirationBehavioural
Breathing exercise
Sham comparator: fast shallow breathingBehavioural
sham breathing exercise
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Paced respiration |
| 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. Receives: Behavioral: Sham comparator: fast shallow breathing |
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 16 weeks
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2009 (estimated)
- Study startApr 2008
- Primary completionJun 2011
- Study completionFeb 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hot FlashesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 218 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Janet S Carpenter, PhD, RN, Principal investigator, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00819182
- Sponsor's protocol ID
- 0803-13
- Other IDs
- R01CA132927
- Status last verified
- Feb 2016
- First submitted
- 7 Jan 2009
- Last updated
- 24 Mar 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No: De-identified data available upon request.
Publications
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.
PubMed 22936289
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Breathe-intervention for Hot Flashes, Associated Outcomes, and Interference
- ClinicalTrials.gov ID
- NCT00819182
- Acronym / sponsor ID
- 0803-13
- Conditions
- Hot Flashes
- Keywords
- Menopause, Breast Cancer, Hot Flash, Night Sweats
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 218 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Cancer Institute (NCI)
- Study start
- Apr 2008
- Primary completion
- Jun 2011 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 8 Jan 2009 (estimated)
- Results
- Posted 28 Feb 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Paced respiration | Experimental | Behavioral: Paced respirationThe 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 | Behavioral: Sham comparator: fast shallow breathingThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Paced respirationBreathing exercise | Behavioural | Paced respiration |
| Sham comparator: fast shallow breathingsham breathing exercise | Behavioural | Sham comparator: Fast, shallow breathing |
Primary outcome
Hot Flash Frequency
Time frame: 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.
Hot Flash Severity
Time frame: 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
Time frame: 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.
4 secondary outcomes
Hot Flash Related Daily Interference
Time frame: 16 weeks
Perceived Control Over Hot Flashes
Time frame: 16 weeks
Mood Disturbance
Time frame: 16 weeks
Sleep Disturbance
Time frame: 16 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 22936289Carpenter 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.
- Individual participant dataSharing planned: No. De-identified data available upon request.
Related trials for Hot Flashes
Active, not recruitingPhase 2
Phase IIB Trial of Bazedoxifene Plus Conjugated Estrogens
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Active, not recruitingPhase 3
A Study to Confirm if Fezolinetant Helps Reduce Hot Flashes in Women With Breast Cancer Who Are Having Hormone Therapy
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Internet-Delivered CBT Program for Menopausal Vasomotor Symptoms
Menopause, Menopausal Vasomotor Symptoms
Not yet recruiting
Self-Management Box on Hot Flash in Postmenopausal Women
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Recruiting
Effects of a Dietary Supplement in Women With Late Perimenopause or Early Postmenopause
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Janet S Carpenter, PhD, RN principal investigator
Indiana University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Paced respiration in people with Hot Flashes, run by Indiana University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Feb 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hot Flash Frequency (time frame: 16 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00819182, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2016.