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Breathe for Hot Flashes Randomized Controlled Trial

This study has been completed.
Sponsor:
Collaborators:
National Institutes of Health (NIH)
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Indiana University
ClinicalTrials.gov Identifier:
NCT00819182
First received: January 7, 2009
Last updated: February 24, 2016
Last verified: February 2016
Results First Received: May 1, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Outcomes Assessor);   Primary Purpose: Supportive Care
Condition: Hot Flashes
Interventions: Behavioral: Paced respiration
Behavioral: Sham comparator: fast shallow breathing

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
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.

Participant Flow:   Overall Study
    Paced Respiration   Fast, Shallow Breathing   Usual Care
STARTED   88 [1]   86 [1]   44 [1] 
Week 16 Visit   75   78   43 
COMPLETED   75   78   43 
NOT COMPLETED   13   8   1 
[1] Consented participants allocated to this arm.



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
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.
Total Total of all reporting groups

Baseline Measures
   Paced Respiration   Fast, Shallow Breathing   Usual Care   Total 
Overall Participants Analyzed 
[Units: Participants]
 88   86   44   218 
Age 
[Units: Years]
Mean (Standard Deviation)
 53.44  (6.84)   51.93  (6.81)   53.52  (5.68)   52.86  (6.62) 
Gender 
[Units: Participants]
       
Female   88   86   44   218 
Male   0   0   0   0 
Ethnicity (NIH/OMB) 
[Units: Participants]
       
Hispanic or Latino   3   0   0   3 
Not Hispanic or Latino   85   86   44   215 
Unknown or Not Reported   0   0   0   0 
Race (NIH/OMB) 
[Units: Participants]
       
American Indian or Alaska Native   1   0   0   1 
Asian   1   0   0   1 
Native Hawaiian or Other Pacific Islander   0   0   0   0 
Black or African American   23   21   12   56 
White   61   62   32   155 
More than one race   2   3   0   5 
Unknown or Not Reported   0   0   0   0 
Region of Enrollment 
[Units: Participants]
       
United States   88   86   44   218 
Breast Cancer History [1] 
[Units: Participants]
       
Breast Cancer Survivor   38   38   20   96 
Menopausal Women with No Cancer History   50   48   24   122 
[1] 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
Hot Flash Frequency [1] 
[Units: Hot flashes per 24 hr]
Mean (Standard Deviation)
 7.02  (4.32)   6.43  (3.96)   7.31  (4.04)   6.84  (4.12) 
[1] 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 [1] 
[Units: Scores on a scale]
Mean (Standard Deviation)
 4.50  (1.60)   5.23  (1.58)   5.40  (1.26)   5.17  (1.53) 
[1] Self-reported rating using a scale from 0 (not at all severe) to 10 (extremely severe). Calculated as 24 hour averages.
Hot Flash Bother [1] 
[Units: Scores on a scale]
Mean (Standard Deviation)
 4.52  (1.72)   4.78  (1.72)   4.69  (1.32)   4.66  (1.64) 
[1] Self-reported rating using a scale from 0 (not at all bothersome) to 10 (extremely bothersome). Calculated as 24 hour averages.
Hot Flash Related Daily Interference [1] 
[Units: Scores on a scale]
Mean (Standard Deviation)
 3.99  (2.35)   4.58  (2.46)   4.51  (2.61)   4.32  (2.43) 
[1] 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.
Perceived Control Over Hot Flashes [1] 
[Units: Scores on a scale]
Mean (Standard Deviation)
 37.38  (4.68)   37.48  (5.10)   37.95  (4.64)   37.57  (4.80) 
[1] 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.
Mood Disturbance [1] 
[Units: Scores on a scale]
Mean (Standard Deviation)
 40.08  (24.77)   47.17  (23.03)   39.50  (24.47)   43.03  (23.86) 
[1] 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.
Sleep Disturbance [1] 
[Units: Global sleep quality score]
Mean (Standard Deviation)
 7.38  (3.23)   8.59  (3.59)   8.14  (3.66)   7.99  (3.50) 
[1] 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
  Show All Outcome Measures

1.  Primary:   Hot Flash Frequency   [ Time Frame: 16 weeks ]

2.  Primary:   Hot Flash Severity   [ Time Frame: 16 weeks ]

3.  Primary:   Hot Flash Bother   [ Time Frame: 16 weeks ]

4.  Secondary:   Hot Flash Related Daily Interference   [ Time Frame: 16 weeks ]

5.  Secondary:   Perceived Control Over Hot Flashes   [ Time Frame: 16 weeks ]

6.  Secondary:   Mood Disturbance   [ Time Frame: 16 weeks ]

7.  Secondary:   Sleep Disturbance   [ Time Frame: 16 weeks ]

8.  Other Pre-specified:   Intervention Performance   [ Time Frame: 2 weeks ]

9.  Other Pre-specified:   Intervention Performance   [ Time Frame: 16 weeks ]

10.  Other Pre-specified:   Intervention Adherence   [ Time Frame: 16 weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Janet S Carpenter, PhD, RN, FAAN
Organization: Indiana University
phone: 317-278-6093
e-mail: carpentj@iupui.edu


Publications of Results:

Responsible Party: Indiana University
ClinicalTrials.gov Identifier: NCT00819182     History of Changes
Other Study ID Numbers: 0803-13
R01CA132927 ( US NIH Grant/Contract Award Number )
Study First Received: January 7, 2009
Results First Received: May 1, 2013
Last Updated: February 24, 2016
Health Authority: United States: Institutional Review Board
United States: Federal Government