Skin Conduction Device for Measuring Hot Flashes in Postmenopausal Women With Hot Flashes
RATIONALE: Measuring how often hot flashes occur in postmenopausal women may be done by using a skin conduction device or by using a diary.
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.
|Study Design:||Masking: Open Label
Primary Purpose: Diagnostic
|Official Title:||A Trial to Examine the Accuracy of an Ambulatory Sternal Skin Conductance Recording Tool to Measure Hot Flashes|
- 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 [ Designated as safety issue: No ]
- Comfort, obtrusiveness, and feasibility of using the skin conductance recording tool [ Designated as safety issue: No ]
|Study Start Date:||May 2006|
|Primary Completion Date:||June 2007 (Final data collection date for primary outcome measure)|
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00427622
|United States, Minnesota|
|Mayo Clinic Cancer Center|
|Rochester, Minnesota, United States, 55905|
|Study Chair:||Debra Barton, RN, PhD, AOCN, FAAN||Mayo Clinic|