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Completed

NCT Number: NCT00819182

Breathe for Hot Flashes Randomized Controlled Trial

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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Key information

Conditions

Hot Flashes Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Pathological Conditions, Signs and Symptoms Signs and Symptoms Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Indiana University School of Nursing

Indianapolis, Indiana, 46202, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Paced respiration

Behavioral

Breathing exercise

Sham comparator: fast shallow breathing

Behavioral

sham breathing exercise

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Other outcomes

  1. Intervention Performance

    Time frame: 2 weeks

    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. Intervention Performance

    Time frame: 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.

  3. Intervention Adherence

    Time frame: 16 weeks

    Number of breathing practice sessions per participant over the 16 week study period.

Sponsors and collaborators

Lead sponsor

Indiana University

Other

Collaborators

  • National Cancer Institute (NCI)
  • National Institutes of Health (NIH)

Registry information

Official study title

Breathe-intervention for Hot Flashes, Associated Outcomes, and Interference

Important dates

Study start
2008
Primary completion
2011
Study completion
2013
First posted
Jan 8, 2009
Registry last updated
Mar 24, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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