Efficacy Verification in Early Diagnosis and Management of Lymphedema Through Home Body Water Analyzer

Recruiting

Brief Summary: Breast cancer is the second most common cancer in women. One in five women who have been treated for breast cancer develop lymphedema. Lymphedema is a very common result of breast cancer and its treatment. Lymphedema is the build-up of fluid in tissues, which results in tissue swelling. The lymph system is a network of lymph vessels, tissues, and organs that carry extra fluid from your cells/tissues throughout the body. If this lymph fluid is not able to flow in the body how it should, there will be swelling which can lead to lymphedema. It can be classified into stages 0 to 3 depending on the severity of the condition. Stages 0 and 1 are reversible, and through early diagnosis and treatment, the recovery to the normal volume and normal skin status of arms can be possible. On the other hand, stage 2 or higher is irreversible, and tissue fibrosis progresses and cannot return to normal skin; therefore, it is important to detect early and start treatment.

This is an observational longitudinal study. Potential participants will be recruited for follow-up after breast cancer surgery. Only patients who fit the inclusion criteria will be considered for participation in the study and contacted by the healthcare provider. Standard of care will be used to guide any treatment needed by participants while they are part of the study.

Recruitment & Eligibility

Inclusion Criteria

Adults 18 and over who are diagnosed with unilateral breast cancer.
Unilateral lumpectomy, unilateral mastectomy, or simultaneous contralateral prophylatic mastectomy within 12 months of enrollment
Axillary lymph node dissection or sentinel node biopsy within 12 months of enrollment
Adjuvant or neoadjuvant chemotherapy and/or radiation therapy are allowed
Breast cancer reconstruction completed or planned is allowed
Study participants must own or have access to a smartphone, iPhone (IOS version 9.0 or above) or Android phone (Android 8.1 or above).

Exclusion Criteria

Bilateral breast cancer
Previous history of breast cancer prior to current diagnosis.
Existing diagnosis of lymphedema at the time of enrollment
Cellulitis or other active infection at the time of enrollment
Adults who are unable to consent.
Pregnant women
Prisoners
Individuals under the age of 18 years old
Individuals who are illiterate
Individuals who lack the capacity to consent
Non-English speakers
Individuals with medical implant devices such as pacemakers, or essential support devices such as patient monitoring systems.

Arm && Interventions

Group	Intervention	Description
Study group	No intervention	breast cancer patients 1-12 months post surgery

Primary Outcome Measures

Name	Time	Method
Measurement of impedances and extracellular water (ECW) ratio	3, 6, 9, and 12 months	Measurement of impedances and extracellular water (ECW) ratio between affected and unaffected sides at initial visit using the clinical and home units (InBody 770 and InBody BWA ON). Inbody BWA 770 Timeline: baseline, 3, 6, 9, 12 month Inbody BWA ON Timeline: 2x/day x 12 months

Secondary Outcome Measures

Name	Time	Method
Impact of lymphedema	baseline, 3, 6, 9, and 12 months	Lymphedema Life Impact Scale questionnaire LLIS consists of 18 questions divided into physical, functional, and psychosocial domains. The questions are rated from 0-4 with 0 being no symptoms and 4 being severe symptoms.
attitudes	12 months	Measure qualitative responses through exit interviews with participants to learn their attitudes toward their evaluation with the home BIA home device at 12 months.
Skin/tissue assessment	baseline, 3, 6, 9, and 12 months	Skin/Tissue Assessment: Items assessed include Axillary Web Syndrome (present or absent), presence of visible/palpable lymphedema (location and severity-min/mod/severe), Stemmer's sign (positive or negative).
Measurement of impedances and extracellular water (ECW) ratio	3, 6, 9, and 12 months	Measurement of impedances and extracellular water (ECW) ratio between affected and unaffected sides at 3, 6, 9, and 12 months using the clinical and home units.
Bilateral upper extremity shoulder goniometric range of motion measurements	baseline, 3, 6, 9, and 12 months	measured in degrees
Disabilities	baseline, 3, 6, 9, and 12 months	Disabilities of the Arm, Shoulder and Hand questionnaire The DASH consists of 30 items of disability/symptom scale, each scored from 1 to 5. The final score is converted to a scale of 0 to 100 (higher scores represent higher disability).
Bilateral upper extremity girth circumference measurements	baseline, 3, 6, 9, and 12 months	measured in centimeters

Locations (1): University of Minnesota
🇺🇸
Minneapolis, Minnesota, United States