LymphedemaNCT01385488
Bioelectrical Impedance for Self-monitoring of Lymphedema
A study testing self-monitor arm volume in people with Lymphedema, run by Vanderbilt University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Lymphedema
- What is being tested?
- self-monitor arm volume
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteUnited States
- Study dates
- May 2011to Dec 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- pacemakers or internal defibrillators;
- currently undergoing IV chemotherapy or radiation; or
- use of laxatives or diuretics to lose weight.
Trial locations and contacts
1 site in 1 country.
United States1 site
Vanderbilt Univeristy School Of Nursing
Nashville, Tennessee, 37240
About this study
Official title: 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.
Read the 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.
- Conditions
- Lymphedema
- Being tested
- self-monitor arm volume
- Keywords
- lymphedema, breast cancer, self care, bioelectrical impedance, monitoring
- Medical subject headings
- Lymphedema, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
self-monitor arm volumeBehavioural
bioelectrical impedance
| Study group | Role | What they receive |
|---|---|---|
| self-monitoring | Experimental | participants will use bioelectrical impedance to self-monitor arm volume at home Receives: Behavioral: self-monitor arm volume |
| completion of forms | No intervention | participants will complete self-report forms |
What is being measured
The primary outcome is the main question the study is designed to answer.
self care behaviors
individual tasks initiated by a participant to care for their lymphedema that may vary from participant to participant.
Measured: 4 months
Self-care self efficacy
perception of abilty to provide lymphedema self-care
Measured: 4 months
Secondary outcomes (3)
health
lymphedema associated symptoms
Measured: four months
quality of life
quality of life
Measured: 4 months
economics
expense in terms of lost income or out-of pocket payments related to lymphedema.
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2011 (estimated)
- Study startMay 2011
- Primary completionDec 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LymphedemaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sheila Ridner, Vanderbilt University
- Investigators
- Sheila H Ridner, PHD, Principal investigator, Vanderbilt University School of Nursing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01385488
- Sponsor's protocol ID
- 110032
- Status last verified
- Apr 2017
- First submitted
- 28 Apr 2011
- Last updated
- 10 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bioelectrical Impedance for Self-monitoring of Breast Cancer Related Lymphedema
- ClinicalTrials.gov ID
- NCT01385488
- Acronym / sponsor ID
- 110032
- Conditions
- Lymphedema
- Keywords
- lymphedema, breast cancer, self care, bioelectrical impedance, monitoring
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Vanderbilt UniversityUniversity, hospital or other
- Study start
- May 2011
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 30 Jun 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| self-monitoring | Experimental | Behavioral: self-monitor arm volumeparticipants will use bioelectrical impedance to self-monitor arm volume at home |
| completion of forms | No intervention | –participants will complete self-report forms |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (9 listed)
- Healthy Volunteers Phase 1: history of arm surgery or family history of primary lymphedema.
- Lymphedema volunteers Phases 1 \& 2: bilateral lymphedema.
- All volunteers:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| self-monitor arm volumebioelectrical impedance | Behavioural | self-monitoring |
Primary outcome
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.
Self-care self efficacy
Time frame: 4 months
perception of abilty to provide lymphedema self-care
3 secondary outcomes
health
Time frame: four months
quality of life
Time frame: 4 months
economics
Time frame: 4 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2017.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sheila H Ridner, PHD principal investigator
Vanderbilt University School of Nursing
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing self-monitor arm volume in people with Lymphedema, run by Vanderbilt University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
self care behaviors (time frame: 4 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Apr 2017.