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Bioelectrical Impedance for Self-monitoring of Lymphedema

This study is currently recruiting participants.
Verified June 2011 by Vanderbilt University
Sponsor:
Information provided by:
Vanderbilt University
ClinicalTrials.gov Identifier:
NCT01385488
First received: April 28, 2011
Last updated: June 28, 2011
Last verified: June 2011
History of Changes
  Purpose
  • 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.

Condition Intervention Phase
Lymphedema
 Behavioral: self-monitoring of arm volume
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Bioelectrical Impedance for Self-monitoring of Breast Cancer Related Lymphedema

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Vanderbilt University:

Primary Outcome Measures:
  • self care behaviors [ Time Frame: 4 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    perception of abilty to provide lymphedema self-care


Secondary Outcome Measures:
  • health [ Time Frame: four months ] [ Designated as safety issue: No ]
    lymphedema associated symptoms

  • quality of life [ Time Frame: 4 months ] [ Designated as safety issue: No ]
    quality of life

  • economics [ Time Frame: 4 months ] [ Designated as safety issue: No ]
    expense in terms of lost income or out-of pocket payments related to lymphedema.


Estimated Enrollment: 42
Study Start Date: May 2011
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: self-monitoring
participants will use bioelectrical impedance to self-monitor arm volume at home
 Behavioral: self-monitoring of arm volume
bioelectrical impedance
No Intervention: completion of forms
participants will complete self-report forms

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.

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Healthy Volunteers for Phase 1: no known history of cancer or lymphatic disease.
  2. Lymphedema volunteers Phases 1 &2: history of breast cancer and diagnosis of lymphedema in one arm.
  3. All volunteers: ≥ 21 years of age.

Exclusion Criteria:

  1. Healthy Volunteers Phase 1: history of arm surgery or family history of primary lymphedema.
  2. Lymphedema volunteers Phases 1 & 2: bilateral lymphedema.

  3. 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01385488

Locations
United States, Tennessee
Vanderbilt Univeristy School Of Nursing Recruiting
Nashville, Tennessee, United States, 37240
Contact: sheila h ridner, PhD     615-322-0831     Sheila.Ridner@Vanderbilt.edu    
Contact: Candace Bonner, BSW     615-343-3980     Candace.M.Bonner@Vanderbilt.edu    
Principal Investigator: Sheila H. Ridner, PhD            
Sponsors and Collaborators
Vanderbilt University
Investigators
Principal Investigator: Sheila H Ridner, PHD Vanderbilt University School of Nursing
  More Information

No publications provided

Responsible Party: Sheila H. Ridner, Vanderbilt Univeristy School of Nursing
ClinicalTrials.gov Identifier: NCT01385488     History of Changes
Other Study ID Numbers: 110032
Study First Received: April 28, 2011
Last Updated: June 28, 2011
Health Authority: United States: Instutional Review Board

Keywords provided by Vanderbilt University:
lymphedema
breast cancer
self care
bioelectrical impedance
monitoring

Additional relevant MeSH terms:
Breast Neoplasms
Lymphedema
Neoplasms by Site
Neoplasms
 Breast Diseases
Skin Diseases
Lymphatic Diseases

ClinicalTrials.gov processed this record on May 23, 2013