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Prospective Analysis of Symptoms, Functionality and Quality of Life Questionnaires to Evaluate Lymphedema in Patients Following Treatment for Breast Cancer.


N/A
18 Years
N/A
Open (Enrolling)
Female
Lymphedema

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Trial Information

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.


Inclusion Criteria:



- 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

Exclusion Criteria:

- 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

- axillary lymph node malignancy causing Lymphedema (per physician discretion)

- current case of cellulitis

- 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

Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

Upper extremity changes following treatment for breast cancer

Outcome Description:

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.

Outcome Time Frame:

1.5 to 5 years

Safety Issue:

No

Principal Investigator

Alphonse G Taghian, MD PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Massachusetts General Hospital

Authority:

United States: Institutional Review Board

Study ID:

08-540

NCT ID:

NCT01521741

Start Date:

August 2009

Completion Date:

August 2014

Related Keywords:

  • Lymphedema
  • Breast Cancer
  • Lymphedema
  • symptoms
  • Breast Neoplasms
  • Lymphedema

Name

Location

Massachusetts General HospitalBoston, Massachusetts  02114-2617