A Trial to Examine the Accuracy of an Ambulatory Sternal Skin Conductance Recording Tool to Measure Hot Flashes
18 Years
N/A
Female
Hot Flashes
Trial Information
A Trial to Examine the Accuracy of an Ambulatory Sternal Skin Conductance Recording Tool to Measure Hot Flashes
OBJECTIVES:
- 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.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- 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
Type of Study:
Interventional
Study Design:
Masking: Open Label, Primary Purpose: Diagnostic
Outcome Measure:
Correlation of 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
Safety Issue:
No
Principal Investigator
Debra Barton, RN, PhD, AOCN, FAAN
Investigator Role:
Study Chair
Investigator Affiliation:
Mayo Clinic
Authority:
United States: Federal Government
Study ID:
CDR0000526174
NCT ID:
NCT00427622
Start Date:
May 2006
Completion Date:
Related Keywords:
- Hot Flashes
- hot flashes
- Hot Flashes
Name | Location |
|---|---|
| Mayo Clinic Cancer Center | Rochester, Minnesota 55905 |
