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A Trial to Examine the Accuracy of an Ambulatory Sternal Skin Conductance Recording Tool to Measure Hot Flashes


N/A
18 Years
N/A
Not Enrolling
Female
Hot Flashes

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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 CenterRochester, Minnesota  55905