Breast Cancer Clinical Trial
Breathe for Hot Flashes Randomized Controlled Trial
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.
Eligibility 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
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There is 1 Location for this study
Indianapolis Indiana, 46202, United States
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