Breathe for Hot Flashes Randomized Controlled Trial

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.

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.

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