Breathe-Intervention for Hot Flashes, Associated Outcomes, and Interference

Trial name: Breathe-Intervention for Hot Flashes, Associated Outcomes, and Interference

Trial sponsors: Indiana University, NIH, NIC

Study start date: May 2008

Estimated study completion date: March 2012

Trial purpose and overview: For millions of women, hot flashes are frequent, severe, and bothersome events that can interfere with daily life and negatively influence mood, affect, and/or sleep. A recent National Institutes of Health state-of-the-science conference concluded that additional data are needed on the efficacy and appropriateness of non-hormonal hot flash treatments. The randomized, controlled trial evaluates a DVD-based at-home breathing training and practice program to evaluate efficacy for hot flashes.

Study location: Living within a 60-mile radius of Indianapolis

Contacts:
Sherry Fetterman sfetterm@iupui.edu
Jenny L Milata, BSN jelbray@iupui.edu

Ages eligible for study: 18 Years and older

Enrolling healthy volunteers? yes

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
• English-Speaking

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
• Failure to evidence >or= 1 objective HF in a 24 hour period

Other Information Relevant to this Posting
Please refer to this study by its ClinicalTrials.gov identifier: NCT00819182