Prospective Analysis of Symptoms, Functionality and Quality of Life Questionnaires to Evaluate Lymphedema in Patients Following Treatment for Breast Cancer.
The method that we propose for this trial is to administer a condensed form of the
Lymphedema and Breast Cancer Questionnaire (LBCQ) , Disabilities of the Arm Shoulder and
Hand (DASH) and Functional Assessment of Cancer Therapy- Breast quality of life instrument
(FACT-B) as surveys/questionnaires within the clinic. This combined questionnaire is called
the lymphedema evaluation following treatment for breast cancer (LEFT-BC). All patients who
present for a baseline (pre-operative) arm measurement will be offered the opportunity to
participate in this trial. At that point the purpose of the trial will be explained. Any
patient that wishes to participate will be provided the questionnaires to complete and
return (by mail or in person) to the study coordinator prior to surgery. During follow-up
visits, questionnaires will be collected prior to perometer measurements and will be
analyzed in conjunction with the measurements taken on the same day. We will utilize the
questionnaires to evaluate their symptoms, functionality and quality of life (QOL). The
perometer is a well-validated instrument and considered the gold standard today for
quantifying volume in a limb. It is accurate to within a percent and far more accurate than
circumferential measurement using a tape measure. It has been a regular part of the standard
of care for MGH breast cancer patients. Patients are routinely measured at diagnosis, after
surgery, after chemotherapy, after radiation, at four to six-month follow-up visits that
continue for years, and anytime a patient reports with new symptoms of swelling or arm
discomfort outside of these time frames.
Observational
Observational Model: Cohort, Time Perspective: Prospective
Upper extremity changes following treatment for breast cancer
During and following treatment for breast cancer patients' experience a variety of changes in their upper extremities. The subject responses to the LEFT-BC questionnaire obtained at the mandated study points will be analyzed in conjunction with a arm volume measurement. This will allow for the correlation between quantifiable limb volume changes and subject documented changes in arm use and functionality and quality of life.
1.5 to 5 years
No
Alphonse G Taghian, MD PhD
Principal Investigator
Massachusetts General Hospital
United States: Institutional Review Board
08-540
NCT01521741
August 2009
August 2014
Name | Location |
---|---|
Massachusetts General Hospital | Boston, Massachusetts 02114-2617 |