Status:
COMPLETED
Breathe for Hot Flashes Randomized Controlled Trial
Lead Sponsor:
Indiana University
Collaborating Sponsors:
National Institutes of Health (NIH)
National Cancer Institute (NCI)
Conditions:
Hot Flashes
Eligibility:
FEMALE
18+ years
Phase:
NA
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 interven...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2013
Estimated Enrollment :
218 Patients enrolled
Trial Details
Trial ID
NCT00819182
Start Date
April 1 2008
End Date
February 1 2013
Last Update
March 24 2016
Active Locations (1)
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1
Indiana University School of Nursing
Indianapolis, Indiana, United States, 46202