Breathe-intervention for Hot Flashes, Associated Outcomes, and Interference
N/A
18 Years
N/A
18 Years
N/A
Open (Enrolling)
Female
Hot Flashes
Female
Hot Flashes
Trial Information
Breathe-intervention for Hot Flashes, Associated Outcomes, and Interference
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Supportive Care
Outcome Measure:
Hot Flash Frequency
Outcome Time Frame:
Baseline, 8 weeks, and 16 weeks
Safety Issue:
No
Principal Investigator
Janet S Carpenter, PhD, RN
Investigator Role:
Principal Investigator
Investigator Affiliation:
Indiana University
Authority:
United States: Institutional Review Board
Study ID:
0803-13
NCT ID:
NCT00819182
Start Date:
May 2008
Completion Date:
March 2013
Related Keywords:
- Hot Flashes
- Menopause
- Breast Cancer
- Hot Flash
- Night Sweats
- Hot Flashes
Name | Location |
|---|---|
| Indiana University School of Nursing | Indianapolis, Indiana 46202 |
