Prospective Screening for Breast Cancer-related Lymphedema
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|ClinicalTrials.gov Identifier: NCT01521741|
Recruitment Status : Recruiting
First Posted : January 31, 2012
Last Update Posted : August 26, 2020
|Condition or disease||Intervention/treatment|
|Lymphedema||Other: Breast Cancer-Related Lymphedema Screening|
The goal of the study is to create a large, prospectively maintained database with data from multiple objective measurement methods (i.e. perometry and BIS) that has detailed information on patient's symptoms and quality of life measures that can be used to answer research questions.
The study design is prospective in nature, and a questionnaire will be utilized in conjunction with objective measurements before, throughout, and after a patient's treatment for breast cancer. This protocol is designed to mimic the current standard of care screening program with the addition of the quality of life questionnaire and BIS measurements.
Data collection will include medical chart review, perometric arm volume measurements, BIS measurements, and a subjective questionnaire. At their preoperative multidisciplinary breast cancer clinic appointment, patients will undergo baseline arm volume measurements per standard of care. At this time, eligible patients will be offered this study. Those who consent will be given a baseline questionnaire to fill out and have baseline BIS measurements taken. Throughout their treatment and follow-up, patients will periodically have BCRL screening every 2-12 months depending on their risk (i.e. patients who are high risk for BCRL because of extensive lymph node surgery will be measured more often than patients who did not have lymph nodes removed). These screening visits will coincide with naturally occurring oncology follow-up visits; although, patients are also screened when patient or provider requests and questionnaires/BIS measurements will be offered at these time points as well.
|Study Type :||Observational|
|Estimated Enrollment :||10000 participants|
|Official Title:||Prospective Screening for Breast Cancer-related Lymphedema: Analysis of Objective Measurements, Symptoms, Functionality, and Quality of Life Questionnaires to Evaluate Lymphedema in Patients Following Treatment for Breast Cancer.|
|Study Start Date :||August 2009|
|Estimated Primary Completion Date :||October 2025|
|Estimated Study Completion Date :||December 2026|
Other: Breast Cancer-Related Lymphedema Screening
All patients enrolled in the trial will receive prospective BCRL screening from their pre-operative baseline throughout their breast cancer treatment process. All participants will be measured with perometry, bioimpedance spectroscopy, and patient-reported outcome measures.
- Upper extremity changes following treatment for breast cancer [ Time Frame: 1.5 to 5 years ]During and following treatment for breast cancer patients' experience a variety of changes in their upper extremities. The subject responses to the patient-reported outcome measures (BCLE-SEI questionnaire) obtained throughout their breast cancer treatment process will be analyzed in conjunction with arm volume measurements taken with both perometry and bioimpedance spectroscopy. This will allow for the correlation between quantifiable limb volume changes and subject documented changes in arm use and functionality and quality of life.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01521741
|United States, Massachusetts|
|Massachusetts General Hospital||Recruiting|
|Boston, Massachusetts, United States, 02134|
|Contact: Alphonse G Taghian, MD PhD 617-726-6050 email@example.com|
|Principal Investigator: Alphonse G Taghian, MD PhD|
|Principal Investigator:||Alphonse G Taghian, MD PhD||Massachusetts General Hospital|