The primary objectives of this study are twofold: 1) to detect and determine the level of
symptoms, functional disability, and changes in quality of life that breast cancer
patients experience from changes in their arms during and after treatment for breast
cancer by collecting patient reported outcome measures, objective measurements, and
clinical information in a prospectively maintained database and 2) to improve breast
cancer-related lymphedema outcomes by early detection using objective measurements and
symptoms assessments and assess these outcomes by maintaining the data in a database in
order to contribute to the literature. The secondary aim of this study is to assess
extracellular fluid content in the upper extremity, breast, and/or trunk of patients
treated for breast cancer before, during, and after treatment in order to better
understand the role of bioimpedance spectroscopy in lymphedema screening.
Additional locations may be listed on ClinicalTrials.gov for NCT01521741.
Locations matching your search criteria
United States
Massachusetts
Boston
Massachusetts General Hospital Cancer CenterStatus: Active
Name Not Available
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.
Trial PhaseNo phase specified
Trial TypeNot provided by clinicaltrials.gov
Lead OrganizationMassachusetts General Hospital
Principal InvestigatorAlphonse G. Taghian