Clinical Trial: Breathe for Hot Flashes Randomized Controlled Trial

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

Brief 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.

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.

Detailed Summary:
Sponsor: Indiana University

Current 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.

Original Primary Outcome: Hot Flash Frequency [ Time Frame: Baseline, 8 weeks, and 16 weeks ]

Current Secondary Outcome:

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

Original Secondary Outcome:

Information By: Indiana University

Dates:
Date Received: January 7, 2009
Date Started: April 2008
Date Completion:
Last Updated: February 24, 2016
Last Verified: February 2016