Morbidity Following the Diagnosis and Treatment of Patients With Breast Cancer
Condition: Breast Cancer; Lymphedema; Physical Therapy; Shoulder
MeSH terms: Breast Neoplasms; Lymphedema
Study type: Observational

Summary: 
      This study will examine the frequency and severity of problems in women with breast cancer
      during the first year after initial medical treatment, including:

        -  Physical impairments, such as loss of strength or flexibility, increased weight and
           swelling

        -  Symptom distress, such as pain, fatigue and weakness.

        -  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.

      It will identify factors associated with these problems and try to determine their
      relationship to them.

      Patients 18 years of age and older with stage I, II, III or IV breast cancer may be eligible
      for this study. Participants will be drawn from patients referred to the National Naval
      Medical Center for diagnosis and treatment during 2000-20001.

      Participants will be interviewed and their medical records reviewed for past medical history,
      history of the present illness and social and recreational history. They will be seen five
      times over a 1-year period (initial visit and at 3, 6, 9, and 12 months), for 30-minute
      visits, which will include the following:

        -  Interview about past medical history and present illness, social and recreational
           activities, functional independence at work and during activities of daily living.

        -  Complete health survey and upper limb disability questionnaire; physical activity
           questionnaire to be completed at 6 and 12 months after medical treatment begins. The
           questionnaires take about 30 to 40 minutes to complete.

        -  Upper body examination, including pain measurement using a 10-point scale, an upper limb
           lift test, and measures of upper limb volume and girth.
    

Detailed description: 
      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).
    

Observational model: Cohort
Time perspective: Prospective
Keywords: Fatigue; Shoulder function; Lymphedema; Breast Cancer; Breast Cancer Surgery; Quality of Life