COMPLETED

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

Conditions

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2024-06-12
Study Completion:2025-09-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:COMPLETED

Study ID

NCT06580743

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Adults 18 and over who are diagnosed with unilateral breast cancer.
  2. * Unilateral lumpectomy, unilateral mastectomy, or simultaneous contralateral prophylatic mastectomy within 12 months of enrollment
  3. * Axillary lymph node dissection or sentinel node biopsy within 12 months of enrollment
  4. * Adjuvant or neoadjuvant chemotherapy and/or radiation therapy are allowed
  5. * Breast cancer reconstruction completed or planned is allowed
  6. * 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).
  1. * Bilateral breast cancer
  2. * Previous history of breast cancer prior to current diagnosis.
  3. * Existing diagnosis of lymphedema at the time of enrollment
  4. * Cellulitis or other active infection at the time of enrollment
  5. * Adults who are unable to consent.
  6. * Pregnant women
  7. * Prisoners
  8. * Individuals under the age of 18 years old
  9. * Individuals who are illiterate
  10. * Individuals who lack the capacity to consent
  11. * Non-English speakers
  12. * Individuals with medical implant devices such as pacemakers, or essential support devices such as patient monitoring systems.

Contacts and Locations

Principal Investigator

Linda A Koehler, PhD
PRINCIPAL_INVESTIGATOR
University of Minnesota

Study Locations (Sites)

University of Minnesota
Minneapolis, Minnesota, 55414
United States

Collaborators and Investigators

Sponsor: University of Minnesota

  • Linda A Koehler, PhD, PRINCIPAL_INVESTIGATOR, University of Minnesota

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-06-12
Study Completion Date2025-09-30

Study Record Updates

Study Start Date2024-06-12
Study Completion Date2025-09-30

Terms related to this study

Additional Relevant MeSH Terms

  • Breast Cancer