NCT00427622

Brief Summary

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2006

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

January 25, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 29, 2007

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2007

Completed
Last Updated

April 9, 2014

Status Verified

June 1, 2007

Enrollment Period

1.1 years

First QC Date

January 25, 2007

Last Update Submit

April 7, 2014

Conditions

Hot Flashes

Keywords

hot flashes

Outcome Measures

Primary Outcomes (2)

  • 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

  • Comfort, obtrusiveness, and feasibility of using the skin conductance recording tool

Interventions

physiologic testingOTHER

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic Cancer Center

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Hot Flashes

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Debra Barton, RN, PhD, AOCN, FAAN

    Mayo Clinic

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Masking
NONE
Purpose
DIAGNOSTIC
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 25, 2007

First Posted

January 29, 2007

Study Start

May 1, 2006

Primary Completion

June 1, 2007

Last Updated

April 9, 2014

Record last verified: 2007-06

Locations

US(1)