Skin Conduction Device for Measuring Hot Flashes in Postmenopausal Women With Hot Flashes
NCT ID: NCT00427622
Last Updated: 2014-04-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
25 participants
INTERVENTIONAL
2006-05-31
Brief Summary
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PURPOSE: This clinical trial is comparing a skin conduction device with a hot flash diary as a way of measuring hot flashes in postmenopausal women with hot flashes.
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Detailed Description
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* Correlate hot flash frequency, as measured by an ambulatory sternal skin conductance measuring and recording tool, with patient-recorded hot flash frequency using a hot flash diary in postmenopausal women with hot flashes.
* Determine the comfort, obtrusiveness, and feasibility of using the skin conductance recording tool for measuring hot flashes when worn daily for five weeks in these patients.
OUTLINE: Patients wear an ambulatory sternal skin conductance hot flash device continuously for 5 weeks.
Patients complete hot flash diaries once daily for 5 weeks. Patients also complete the Comfort, Bother, and Weight Questionnaire at the end of week 5.
PROJECTED ACCRUAL: A total of 25 patients will be accrued for this study.
Conditions
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Study Design
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DIAGNOSTIC
NONE
Interventions
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physiologic testing
Eligibility Criteria
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Inclusion Criteria
* Diagnosis of bothersome hot flashes, defined by their occurrence of ≥ 4 times/day
* Daily hot flashes have been present for ≥ 1 month
PATIENT CHARACTERISTICS:
* Female
* Postmenopausal
* ECOG performance status 0-1
* No history of allergic or other adverse reactions to adhesives
* No other medical condition known to cause sweating and/or flushing
* Willing to record hot flashes in a hot flash diary daily for 5 weeks
* Willing to wear a skin conductance device 24 hours a day for 5 weeks
* No implanted pacemakers or metal implants
* No reliance on other electronic devices for regular monitoring (i.e., insulin pumps or blood pressure monitors)
PRIOR CONCURRENT THERAPY:
* Not specified
18 Years
FEMALE
No
Sponsors
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Mayo Clinic
OTHER
Responsible Party
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Principal Investigators
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Debra Barton, RN, PhD, AOCN, FAAN
Role: STUDY_CHAIR
Mayo Clinic
Locations
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Mayo Clinic Cancer Center
Rochester, Minnesota, United States
Countries
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Other Identifiers
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MC05CC
Identifier Type: OTHER
Identifier Source: secondary_id
MC05CC
Identifier Type: -
Identifier Source: org_study_id
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