Bioelectrical Impedance for Self-monitoring of Lymphedema
Completed · Not applicable
Conditions studied: Lymphedema
In brief
* 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.
Key facts
- Study ID
- NCT01385488
- Run by
- Vanderbilt University
- People needed
- 72
- Starts
- 2011-05-01
- Expected to finish
- 2012-12-01
- Last updated by the study team
- 2017-04-10
Who can join
Age: 21 and older. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Healthy Volunteers for Phase 1: no known history of cancer or lymphatic disease.
- Lymphedema volunteers Phases 1 \&2: history of breast cancer and diagnosis of lymphedema in one arm.
- All volunteers: ≥ 21 years of age.
You may not qualify if…
- Healthy Volunteers Phase 1: history of arm surgery or family history of primary lymphedema.
- Lymphedema volunteers Phases 1 \& 2: bilateral lymphedema.
- All volunteers:
- inability to stand upright;
- conditions that could cause swelling: pregnancy, congestive heart failure, liver failure;
- infection, open sores on arms, or known sensitivity to electrodes;
- pacemakers or internal defibrillators;
- currently undergoing IV chemotherapy or radiation; or
- use of laxatives or diuretics to lose weight.
Where it is running
- Vanderbilt Univeristy School Of Nursing — Nashville, Tennessee, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.