- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01385488
Bioelectrical Impedance for Self-monitoring of Lymphedema
Bioelectrical Impedance for Self-monitoring of Breast Cancer Related 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.
- 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.
Study Overview
Detailed Description
Breast cancer treatment-related lymphedema (swelling) is an incurable, chronic condition experienced by a significant percentage of breast cancer survivors. It has many associated symptoms, negatively impacts quality of life (QOL), and increases health care costs. As with other chronic diseases, such as diabetes, life-long self-care is required. No objective measurement mechanism exists that can easily be used to self-monitor arm volume, a key self-care outcome. Those with lymphedema are forced to rely on visual recognition of increasing volume to know if their self-care is effective and when to seek treatment. Timely recognition of worsening swelling is believed to result in better patient outcomes; however, substantial volume increases often occur before observable changes are noted and this window of opportunity is missed. Many with lymphedema only seek care when they have developed infection in the swollen limb.
The inability to objectively monitor arm volume on a regular basis likely results in discomfort, poorer QOL, and increased health care costs.The broad, long-term objective of this application is to develop a method for monitoring arm lymphedema that can be used at home to improve lymphedema self-management and patient outcomes. To accomplish this, the investigators will conduct a two-phase, translational pilot study to explore the use of a hand-held bioelectrical impedance device as an arm volume self-measurement method.
The purpose of Phase 1 is to develop a bioelectrical impedance self-measurement protocol. Healthy volunteers (n=11) and individuals with lymphedema (n=11) will be in Phase 1 (protocol development). This will take place in laboratory and home settings. This Phase is not interventional and is not detailed in this posting.
The purpose of Phase 2 is to compare self-care activities and health and economic outcomes between breast cancer survivors with lymphedema following the self-monitoring protocol developed in Phase 1 and breast cancer survivors with lymphedema not on protocol (n=42).The protocol will be field-tested by breast cancer survivors with lymphedema in Phase 2 (a two group randomized clinical trial). One group will self-measure with impedance at home for three months, weekly record self-care activities, and will complete follow-up assessments. The other group will mirror Group 1 except for impedance measurements. This is an interventional study and is presented as such in this clinical trial posting.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Tennessee
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Nashville, Tennessee, United States, 37240
- Vanderbilt Univeristy School Of Nursing
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: self-monitoring
participants will use bioelectrical impedance to self-monitor arm volume at home
|
bioelectrical impedance
|
No Intervention: completion of forms
participants will complete self-report forms
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
self care behaviors
Time Frame: 4 months
|
individual tasks initiated by a participant to care for their lymphedema that may vary from participant to participant.
|
4 months
|
Self-care self efficacy
Time Frame: 4 months
|
perception of abilty to provide lymphedema self-care
|
4 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
health
Time Frame: four months
|
lymphedema associated symptoms
|
four months
|
quality of life
Time Frame: 4 months
|
quality of life
|
4 months
|
economics
Time Frame: 4 months
|
expense in terms of lost income or out-of pocket payments related to lymphedema.
|
4 months
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 110032
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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