Finding studies
Finding studies
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Lead
National Institutes of Health Clinical Center (CC)
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).
Age
18–85
Sex
ALL
Healthy volunteers
Not accepted
