This longitudinal, prospective 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 160 patients diagnosed with breast cancer before and after medical and surgical treatment compared to a control group of 160 women who undergo excisional breast biopsy to rule out breast cancer with negative findings. 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 year after medical treatment). The proposed outcome study will include: 1) a two year longitudinal, prospective design that includes a control group, 2) specific patient process variables such as demographics, medical data, e.g., staging conference information, and the standard upper body clinical examination, and 3) administration of a self-report surveys/questionnaire 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 identity 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. Purpose: to examine the frequency and severity of problems in women with breast cancer for 2 years following initial medical treatment, including: l Physical impairments, such as loss of strength or flexibility, increased weight and swelling l Symptom distress, such as pain, fatigue and weakness. l Functional limitations and disabilities, such as loss of independence in activities of daily living (e.g., grooming, bathing, dressing, driving a car), work and social and recreational activities. to identify factors associated with these problems and try to determine their relationship to them.

Agency
National Institute of Health (NIH)
Institute
Clinical Center (CLC)
Type
Intramural Research (Z01)
Project #
1Z01CL060058-04
Application #
7215879
Study Section
(RM)
Project Start
Project End
Budget Start
Budget End
Support Year
4
Fiscal Year
2005
Total Cost
Indirect Cost
Name
Clinical Center
Department
Type
DUNS #
City
State
Country
United States
Zip Code