Trial Information

A Prospective (Cohort) Study to Identify Factors Affecting 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 (BCC)

This study longitudinal, prospective (cohort) outcome study will describe the frequency and
severity of morbidities and investigate the risk factors for development of morbidity
defined as upper limb impairments, functional limitations and disability in a treatment
group of approximately 300 patients diagnosed with breast cancer before and after medical
and surgical treatment compared to a control group of 300 healthy women.

Subjects will be followed for two-years with periodic examinations (baseline
[pre-surgical/medical treatment] and at 1, 3, 6, 12, 18 and 24 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 (2 years 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 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 symptom distress and 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 five year longitudinal,
prospective design that includes a control groups, 2) specific patient process variables
such as demographics, medical data, e.g. staging conference information, and the standard
upper body clinical examination, and 2) administration of self-report surveys/questionnaires
that measure upper limb functional limitations and disabilities, physical activity and
quality of life at baseline and follow-up at 1, 3, 6, 12, 18 and 24 months. 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
identify those patients at higher risk for the loss of independence in function (e.g.
ADL's), and

3. risk factors for loss of function and disability.