Prospective Analysis of Symptoms and Lymphedema in Patients Following Treatment for Breast Cancer
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The objective of this study is to determine the level of symptoms, functional disability, and changes in quality of life that breast cancer patients experience from changes in their arm(s) during and after treatment for breast cancer. These problems are often associated with transient or chronic lymphedema, numbness, reduced shoulder flexibility, and an altered ability to use the arm for functional activities of daily living. The goal of this study is to collect data to support the hypothesis that swelling and other impairments in the upper extremities, causes a significant level of symptoms, functional disability and diminished quality of life for patients. Furthermore the investigators hope to evaluate how symptoms in the upper extremity (such as decreased functionality, sensory changes, pain or stiffness) are related to early, low volume lymphedema.
Condition or disease
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.
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 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.
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Layout table for eligibility information
Ages Eligible for Study:
18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Newly diagnosed breast cancer patients.
Confirmed diagnosis of breast cancer
No metastatic disease in the cervical or thoracic regions
No bulky disease in the thoracic or cervical region
No history of primary Lymphedema
No prior surgery to the head, neck, upper limb or trunk
No prior radiation to the head, neck, upper limb or trunk
No evidence of axillary lymph node malignancy causing Lymphedema due to recurrence
metastatic or other locally advanced disease in the cervical or thoracic regions
known brain metastases
history of primary Lymphedema
history of prior surgery or radiation to the head, neck, upper limb or trunk
history of a different malignancy except for the following: History of other malignancies if they are disease-free for 5+ years and deemed by the PI to be at low risk for recurrence OR <5 years of diagnosis and treatment for cervical cancer in situ, basal or squamous cell carcinoma of the skin.
Will not be returning routinely for follow-up at MGH or DFHCC