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NCT01385488 · ClinicalTrials.gov registry record · NA

Bioelectrical Impedance for Self-monitoring of Lymphedema

A NA study, sponsored by Vanderbilt University.

Completed
Registry status
NA
Development phase
72
Enrollment target

NCT01385488 is a NA study that has completed, run by Vanderbilt University. The registered enrollment target is 72 participants.

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The verdict

NCT01385488, a NA study, has completed, sponsored by Vanderbilt University.

COMPLETED
Registry status
NA
Development phase
72 participants
Enrollment target

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.

Interventions

  • BEHAVIORAL self-monitor arm volume

Trial Details

FieldValue
Enrollment Target 72 participants
Start Date 2011-05
Est. Completion 2012-12
Phase NA

Sponsor

Vanderbilt University

430 total trials

What the Registry Record Tells You About NCT01385488

The ClinicalTrials.gov registry entry for NCT01385488 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 72 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Vanderbilt University, which has 430 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 1 intervention - of which self-monitor arm volume is the first listed.

NCT01385488 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT01385488 about?

NCT01385488 is a clinical study titled "Bioelectrical Impedance for Self-monitoring of Lymphedema". * 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. * T...

What is the current status of trial NCT01385488?

This trial is currently completed. It is a NA study. The enrollment target is 72 participants. The study started on 2011-05. Estimated completion is 2012-12.

What interventions are being tested in trial NCT01385488?

The interventions under investigation include: self-monitor arm volume (BEHAVIORAL).

Who is sponsoring clinical trial NCT01385488?

This trial is sponsored by Vanderbilt University, which has 430 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.