This retrospective (case-control) outcome study will investigate the frequency and severity of morbidities in a population of approximately 165 patients diagnosed with breast cancer before and after medical and surgical treatment. The study will be conducted between two sites, the Warren G. Magnuson Clinical Center and the National Naval Medical Center in Bethesda, Maryland. 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. 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). Purpose: to examine the frequency and severity of problems in women with breast cancer during the first year after 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. This study will correlate the frequency and severity of impairment with demographic, characteristics of tumor/stage of disease and treatment-related (surgery, chemotherapy and radiation therapy) factors.? When shoulder impairments and/or lymphedema developed in this cohort, clinical interventions were provided. Case controlled analysis was done on 43 women who developed early lymphedema i.e. greater than 3% volume change compared to baseline. Early treatment of their lymphedema with use of a compression sleeve and gauntlet significantly reduced volume changes. The efficacy of this treatment will be investigated further with the 5 year followup visit.

Agency
National Institute of Health (NIH)
Institute
Clinical Center (CLC)
Type
Intramural Research (Z01)
Project #
1Z01CL060057-06
Application #
7593131
Study Section
Project Start
Project End
Budget Start
Budget End
Support Year
6
Fiscal Year
2007
Total Cost
$99,600
Indirect Cost
Name
Clinical Center
Department
Type
DUNS #
City
State
Country
United States
Zip Code