Clinical trial NCT00819182: Breathe for Hot Flashes Randomized Controlled Trial
Official title: Breathe-intervention for Hot Flashes, Associated Outcomes, and Interference
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hot Flashes
Keywords: Menopause
Breast Cancer
Hot Flash
Night Sweats
Lead sponsor: Indiana University
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: National Cancer Institute (NCI)
First posted: 2009-01-08
Enrollment: 218
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


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

Primary outcomes:
measure: Hot Flash Frequency
timeFrame: 16 weeks
measure: Hot Flash Severity
timeFrame: 16 weeks
measure: Hot Flash Bother
timeFrame: 16 weeks
Secondary outcomes:
measure: Hot Flash Related Daily Interference
timeFrame: 16 weeks
measure: Perceived Control Over Hot Flashes
timeFrame: 16 weeks
measure: Mood Disturbance
timeFrame: 16 weeks
measure: Sleep Disturbance
timeFrame: 16 weeks
Other outcomes:
measure: Intervention Performance
timeFrame: 2 weeks
measure: Intervention Performance
timeFrame: 16 weeks
measure: Intervention Adherence
timeFrame: 16 weeks
Locations:
city: Indianapolis
country: United States
facility: Indiana University School of Nursing
state: Indiana
Study officials:
affiliation: Indiana University
name: Janet S Carpenter, PhD, RN
role: PRINCIPAL_INVESTIGATOR
References:
citation: Carpenter JS, Burns DS, Wu J, Otte JL, Schneider B, Ryker K, Tallman E, Yu M. Paced respiration for vasomotor and other menopausal symptoms: a randomized, controlled trial. J Gen Intern Med. 2013 Feb;28(2):193-200. doi: 10.1007/s11606-012-2202-6.