CompletedNot Applicable

Lymphedema Specific PROs for Risk Assessment, Prevention and Early Detection

United States101 participantsStarted 2021-01-13

Plain-language summary

The purpose of this study is to find a way to detect a surgical complication, called lymphedema, at an earlier stage. This potential complication may develop in some patients after removal of the armpit lymph nodes (axillary dissection). It is very important to identify this condition as early as possible to improve the treatment options. This study will examine whether or not focused questionnaires are able to identify lymphedema, comparing to physical measurements (like arm circumference).

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Patients 18 years old and older with biopsy-proven breast cancer. * Scheduled for axillary dissection or probable axillary dissection or within 14 days after axillary dissection at either Jackson Memorial Hospital (JMH) or University of Miami (UM). * Patients that eventually did not undergo full axillary dissection but had 9 or more lymph nodes removed or received axillary radiation will be allowed to stay in the study. * Intent to continue follow-up for at least 6 months post-operatively. * Able to give an informed consent to participate in all study's stages. * Willing and able to fill questionnaires in person or with assistance at baseline and at 6 months from surgery. * Bilateral axillary dissection patients are eligible to be enrolled for each side. Exclusion Criteria: * Previous axillary dissection. * Lymph node biopsy except for biopsies related to the current cancer event. * Congenital or acquired arm lymphedema. * Nephrotic Syndrome * Anasarca * Unable or unwilling to fill questionnaires at baseline and at 6 months from surgery.

What they're measuring

Change in Functional Assessment of Cancer Therapy Questionnaire for Breast Cancer (FACT-B+4) PRO Scores

Timeframe: Baseline (pre-operative), postoperative, up to 6 months

Change in Lymphoedema Functioning, Disability and Health Questionnaire (Lymph-ICF) PRO Scores

Timeframe: Baseline (pre-operative), postoperative, up to 6 months

Change in Quality of Life Measure for Limb Lymphoedema (LYMQOL) Scores

Timeframe: Baseline (pre-operative), up to 6 months

Change in Lymphedema rate as measured by L-DEX Test

Timeframe: Baseline, Up to 6 months

Trial details

NCT IDNCT05929001

SponsorUniversity of Miami

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2024-12-31

View on ClinicalTrials.gov More Lymphedema trials

Plain-language summary

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Change in Functional Assessment of Cancer Therapy Questionnaire for Breast Cancer (FACT-B+4) PRO Scores

Timeframe: Baseline (pre-operative), postoperative, up to 6 months

Change in Lymphoedema Functioning, Disability and Health Questionnaire (Lymph-ICF) PRO Scores

Timeframe: Baseline (pre-operative), postoperative, up to 6 months

Change in Quality of Life Measure for Limb Lymphoedema (LYMQOL) Scores

Timeframe: Baseline (pre-operative), up to 6 months

Change in Lymphedema rate as measured by L-DEX Test

Timeframe: Baseline, Up to 6 months