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Bioelectrical Impedance for Self-monitoring of Lymphedema

NCT01385488 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 72

Last updated 2017-04-10

No results posted yet for this study

Summary

* Breast cancer treatment-related lymphedema requires life-long self-care is required.
* No objective measurement mechanism exists that can easily be used to self-monitor arm volume.
* Bioelectrical impedance devices approved for lymphedema measurement may be able to be used for self-monitoring.
* The investigators will conduct a two-part study to first develop an impedance driven self-measurement protocal and then test the protocol in home settings.
* The investigators hypothesize in part two of the study that when compared to participants who are not self-monitoring, those who self-monitor limb volume will: 1) report more days of garment use, skin care, and simple-MLD; and, 2) have fewer, less distressful, less intense symptoms, better productivity/activity, report higher perceived self-management/self-efficacy and QOL; experience fewer missed days of work, lymphedema treatment days, arm infections, and have a smaller number of antibiotic prescriptions.

Conditions

  • Lymphedema

Interventions

BEHAVIORAL

self-monitor arm volume

bioelectrical impedance

Sponsors & Collaborators

  • Vanderbilt University

    lead OTHER

Principal Investigators

  • Sheila H Ridner, PHD · Vanderbilt University School of Nursing

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-05-31
Primary Completion
2012-12-31
Completion
2012-12-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01385488 on ClinicalTrials.gov