Hot Flashes Clinical Trial
Official title:
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 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.
n/a
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Supportive Care
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