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View Clinical Trial (Medical Research Study)
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Breathe for Hot Flashes - NCT00819182-46202 (Clinical Trial 262876)
Permalink: http://www.ClinicalConnection.com/exp/ExpandedPatientViewStudy262876.aspx
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| City: |
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Indianapolis |
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State:
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IN |
| Zip Code: |
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46202 |
| Conditions: |
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Hot Flashes |
| Purpose: |
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For millions of breast cancer survivors (BCS) and menopausal women without breast cancer
(MW), hot flashes are frequent, severe, and bothersome events that can interfere with daily
life and negatively influence mood, affect, and/or sleep. Unfortunately, the scientific
basis for managing hot flashes is limited. The major conclusion from a recent National
Institutes of Health state-of-the-science conference was that additional data are needed on
the efficacy and appropriateness of non-hormonal hot flash treatments. Although breathing
has been recommended by the North American menopause Society as a first-line treatment for
hot flashes, these recommendations are based on two previous studies that included small
numbers of MW, used complex time- and resource-intensive instructional protocol, and
incorporated a narrow range of outcomes. These limitations restrict current evidence for
efficacy and reduce the likelihood that this promising non-hormonal hot flash treatment can
be disseminated into widespread use. The proposed randomized, controlled trial evaluates a
simplified DVD-based vs. CD-based at-home breathing training and practice program against a
no-treatment usual care control condition among BCS and MW without breast cancer. Aims are
to evaluate (1) efficacy for physiologic and subjective hot flashes (objective frequency and
subjective frequency, severity, bother, and duration), (2) efficacy for perceived hot flash
interference and associated outcomes (mood, affect, sleep), (3) differences in efficacy
between BCS and MW without cancer, and (4) acceptability, outcome expectancy, treatment
credibility, and frequency of practice and application. This study will also examine
baseline characteristics as potential covariates of efficacy, including objective hot flash
frequency, body mass index, race, ethnicity, education prior breath training, smoking
status, menopausal status, use of selective estrogen receptor modulators or aromatase
inhibitors, use of other hot flash treatments, and comorbid conditions. A total of 91 BCS
and 91 MW will be stratified and randomized using a 2:2:1 ratio to DVD, CD, or usual care
groups. Outcomes will be assessed at baseline, 8 and 16 weeks post-intervention by research
assistants masked to randomization group. A portable respiratory transducer will be used to
evaluate breathing depth and rate. Findings will provide empirical evidence for or against
the use of breathing for relieving physiologic and/or subjective hot flashes, perceived hot
flash interference and associated outcomes. Positive or negative findings will guide
clinicians' recommendations and consumers' treatment selections either in favor of, or
against, the use of breathing. If efficacious, acceptable, and usable, the program could be
easily and widely disseminated for use in lieu of, or in addition to, currently available
hot flash treatments.
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| Study summary: |
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| Criteria: |
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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 |
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| Study is available at: |
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Indiana University School of Nursing
Indianapolis, IN 46202
United States
Primary Contact:
Research Staff
Email: nursad1@iupui.edu
Phone: 317-278-6094 |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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March 16, 2010 |
Modifications to
this listing: |
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Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
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Clinical trials are medical research studies designed to test the safety and/or
effectiveness of new drugs, devices, or treatments in humans. These studies are
conducted worldwide for a range of conditions and illnesses. Learn more about
clinical research and participating in a study at
About Clinical Trials.
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