Breathe for Hot Flashes Randomized Controlled Trial

This study has been completed.
Sponsor:
Collaborators:
Information provided by (Responsible Party):
Indiana University
ClinicalTrials.gov Identifier:
NCT00819182
First received: January 7, 2009
Last updated: January 14, 2014
Last verified: January 2014
  Purpose

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 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.


Condition Intervention
Hot Flashes
Behavioral: Paced respiration

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

Resource links provided by NLM:


Further study details as provided by Indiana University:

Primary Outcome Measures:
  • Hot Flash Frequency [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Hot Flash Related Daily Interference [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
    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.

  • Perceived Control Over Hot Flashes [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
    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.


Other Outcome Measures:
  • Intervention Performance [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
    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.

  • Intervention Performance [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
    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.

  • Intervention Adherence [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
    Number of breathing practice sessions per participant over the 16 week study period.


Enrollment: 218
Study Start Date: April 2008
Study Completion Date: February 2013
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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 (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
Breathing exercise
Placebo Comparator: Fast, shallow breathing
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.
No Intervention: 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00819182

Locations
United States, Indiana
Indiana University School of Nursing
Indianapolis, Indiana, United States, 46202
Sponsors and Collaborators
Indiana University
Investigators
Principal Investigator: Janet S Carpenter, PhD, RN Indiana University
  More Information

Publications:
Responsible Party: Indiana University
ClinicalTrials.gov Identifier: NCT00819182     History of Changes
Other Study ID Numbers: 0803-13, R01CA132927
Study First Received: January 7, 2009
Results First Received: May 1, 2013
Last Updated: January 14, 2014
Health Authority: United States: Institutional Review Board
United States: Federal Government

Keywords provided by Indiana University:
Menopause
Breast Cancer
Hot Flash
Night Sweats

Additional relevant MeSH terms:
Hot Flashes
Signs and Symptoms

ClinicalTrials.gov processed this record on April 17, 2014