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Breathe for Hot Flashes
This study is currently recruiting participants.
Verified by Indiana University, January 2009
Sponsors and Collaborators: Indiana University
National Institutes of Health (NIH)
National Cancer Institute (NCI)
Information provided by: Indiana University
ClinicalTrials.gov Identifier: NCT00819182
  Purpose

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 slow deep 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 at-home breathing training and practice program against an attention control and 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 intervention, attention control, 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 slow deep 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 slow deep breathing. If efficacious, acceptable, and usable, this DVD-based program could be easily and widely disseminated for use in lieu of, or in addition to, currently available hot flash treatments.


Condition Intervention
Hot Flashes
Behavioral: Breathe Intervention

Genetics Home Reference related topics: breast cancer
MedlinePlus related topics: Breast Cancer Cancer Menopause
U.S. FDA Resources
Study Type: Interventional
Study Design: Supportive Care, Randomized, Double Blind (Subject, Caregiver, Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study
Official Title: Breathe-Intervention for Hot Flashes, Associated Outcomes, and Interference

Further study details as provided by Indiana University:

Primary Outcome Measures:
  • Hot Flash Frequency [ Time Frame: Baseline, 8 weeks, and 16 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 182
Study Start Date: May 2008
Estimated Study Completion Date: March 2012
Estimated Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Intervention: Experimental Behavioral: Breathe Intervention
Breathing exercise
Attention Control: No Intervention
Usual Care: No Intervention

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00819182

Contacts
Contact: Sherry Fetterman 317-278-6094 sfetterm@iupui.edu
Contact: Jenny L Milata, BSN 317-278-6094 jelbray@iupui.edu

Locations
United States, Indiana
Indiana University School of Nursing Recruiting
Indianapolis, Indiana, United States, 46202
Principal Investigator: Janet S. Carpenter, PhD, RN            
Sponsors and Collaborators
Indiana University
  More Information

Responsible Party: Indiana University ( Janet S. Carpenter, PhD, RN )
Study ID Numbers: R01 CA132927-01, Grant #: 1R01 CA132927-01
Study First Received: January 7, 2009
Last Updated: January 7, 2009
ClinicalTrials.gov Identifier: NCT00819182  
Health Authority: United States: Institutional Review Board;   United States: Federal Government

Keywords provided by Indiana University:
Menopause
Breast Cancer
Hot Flash
Night Sweats

Study placed in the following topic categories:
Signs and Symptoms
Hot Flashes
Breast Neoplasms
Menopause

ClinicalTrials.gov processed this record on January 16, 2009