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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: Completed NA study, sponsored by Vanderbilt University.
NCT01385488 is a NA study that has completed, run by Vanderbilt University. The registered enrollment target is 72 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (95% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
individual tasks initiated by a participant to care for their lymphedema that may vary from participant to participant.
Interventions
- BEHAVIORAL self-monitor arm volume
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 72 participants |
| Start Date | 2011-05 |
| Est. Completion | 2012-12 |
| Phase | NA |
What the finished NCT01385488 record still lists
NCT01385488 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 72 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (95% lower).
The record links to 0 conditions, and to 1 intervention - of which self-monitor arm volume is the first listed.
NCT01385488 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01385488's enrollment target sits among peer trials
72 1089th of 2000 higher than 899 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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