Bioelectrical Impedance for Self-monitoring of Lymphedema

NCT01385488 | Completed

• 1 other identifier: 110032
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Lymphedema

Keywords

lymphedema; breast cancer; self care; bioelectrical impedance; monitoring

Outcome Measures

Primary Outcomes (2)

• self care behaviors

  individual tasks initiated by a participant to care for their lymphedema that may vary from participant to participant.

  4 months

• Self-care self efficacy

  perception of abilty to provide lymphedema self-care

  4 months

Secondary Outcomes (3)

• health

  four months

• quality of life

  4 months

• economics

  4 months

Study Arms (2)

self-monitoring

EXPERIMENTAL

participants will use bioelectrical impedance to self-monitor arm volume at home

Behavioral: self-monitor arm volume

completion of forms

NO INTERVENTION

participants will complete self-report forms

Interventions

self-monitor arm volume BEHAVIORAL

bioelectrical impedance

self-monitoring

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Vanderbilt University: lead

Study Sites (1)

Vanderbilt Univeristy School Of Nursing

Nashville, Tennessee, 37240, United States

Location

MeSH Terms

Conditions

Lymphedema; Breast Neoplasms

Condition Hierarchy (Ancestors)

Lymphatic Diseases; Hemic and Lymphatic Diseases; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Sheila H Ridner, PHD

  Vanderbilt University School of Nursing

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: April 28, 2011
• First Posted: June 30, 2011
• Study Start: May 1, 2011
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: April 10, 2017

Record last verified: 2017-04

Locations

US (1)