Morbidity Following the Diagnosis and Treatment of Patients With Breast Cancer: A Multi-Institutional Study Between the National Institutes of Health (NIH) Rehabilitation Medicine Department (RMD) and the Walter Reed National Military Medical Center (WRNMMC) Breast Care Center

Trial Information

Morbidity Following the Diagnosis and Treatment of Patients With Breast Cancer: A Multi-Institutional Study Between the National Institutes of Health (NIH) Rehabilitation Medicine Department (RMD) and the Walter Reed National Military Medical Center (WRNMMC) Breast Care Center

This retrospective (case-control) outcome study will investigate the frequency and severity
of morbidities in a population of approximately 160 patients diagnosed with breast cancer
before and after medical and surgical treatment. Subjects will be followed for one-year
with quarterly examinations (baseline [pre-medical treatment] and at 1, 3 months, 6 months,
9 months and 12 months after treatment). In order for cancer survivors to understand the
risk of impairment and functional limitations, and disability; and for health care providers
to determine the risk of physical impairment, functional limitations, and loss of
independence (morbidity) in patients with breast cancer; it is necessary to study these
patients from the point of diagnosis (before surgery) to a reasonable period following the
completion of the primary treatment program (1 year after medical treatment). Although
pain, numbness, fatigue, lymphedema and diminished physical function are described as
prevalent and debilitating conditions, remarkably few clinical studies are published
describing the associated physical impairments, functional limitations or on methods for
their control with measures prior to medical intervention and long-term follow-up. While
several past reports have identified the impact of medical and surgical intervention on
symptom distress and functional capacity of these patients, these studies do not provide
sufficient evidence to identify the: 1) level of physical impairment that predicts morbidity
in these patients, 2) individual factors that are specific predictors of morbidity in these
patients, or 3) time period in which these morbidities occur. The majority of previous
studies investigating morbidity of patients with breast cancer following medical and
surgical intervention are cross-sectional, case series, retrospective analysis without a
comparison/control group and without baseline measures prior to intervention. The proposed
outcome study will include: 1) a retrospective review of specific medical record
information such as staging conference information and the standard clinical quarterly
examination during a one year period, and 2) administration of a follow-up outcome
questionnaire, a physical activity questionnaire and a quality of life questionnaire at the
6 and 12 months time points. The outcome survey is an upper limb disability questionnaire
developed as an outcome measure for this project. Data available in these measurement
domains will allow the researchers to determine the: 1) frequency and severity of: a)
symptom distress (fatigue, pain including chronic pain, aching, weakness, burning, tingling,
numbness, anxiety, and depression) and pathological conditions (adhesive capsulitis,
weakness and atrophy, neuropathy, scar/skin adhesions, lymphedema), b) physical impairments
(diminished upper extremity and trunk range of motion/flexibility, strength, coordination
and increased girth), and c) functional imitations and disabilities during the course of the
medical treatment (loss of independence in or ability to perform routine activities of daily
living i.e., grooming, bathing, dressing, driving an automobile, and in some cases, return
to their regular work, recreational and social activities). 2) level of impairment at which
these patients have lost independence in function and identity those patients at higher risk
for the loss of independence in function (e.g., ADL's).