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Home > "M" Clinical Trials Conditions > Morbidity after Diagnosis and Treatment of Breast Cancer Patients  Morbidity after Diagnosis and Treatment of Breast Cancer Patients
Morbidity after Diagnosis and Treatment of Breast Cancer Patients
For Condition: Breast Cancer
Status: Recruiting
Sponsor(s): Warren G Magnuson Clinical Center (CC) ,
Synopsis: This study will examine the frequency and severity of problems in women with breast cancer for 2 years following 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. Women who have a breast biopsy negative for cancer will also be enrolled as control subjects. Participants will be drawn from patients referred to the National Naval Medical Center for diagnosis and treatment during 2001-2003. Participants will be evaluated over a 2-year period during an initial baseline visit (before medical treatment or biopsy) and follow-up visits at 1, 3, 6, 12, 18 and 24 months following procedures: - Interview about past medical history and present illness, social and recreational activities, functional independence at work and during activities of daily living. - Completion of questionnaires including health survey, upper limb disability questionnaire, and physical activity questionnaire. (Questionnaires are completed only at baseline and 12 and 24 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, active and passive range of motion measures, manual muscle testing measures using a 10-point scale, timed upper limb lift test, and measures of upper limb volume and girth.
Details: 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 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 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 two 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 3) 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.
Eligibility:
Study Type: Observational, Natural History
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry Criteria: INCLUSION CRITERIA: Population/Subjects: Individuals with breast cancer and individuals who undergo excisional biopsy negative for breast cancer are identified among the patient population at National Naval Medical Center (NNMC). Patients referred to the NNMC Breast Care Center (NNMC-BCC) for diagnosis and management (surgical treatment and radiation treatment or chemotherapy) of histologically established breast cancer (stage I, II, III, or IV) during 2001-2003, are eligible to participate in the study. Subjects must be over age 18 and post-puberty as breast cancer does not occur prior to puberty; and been seen pre-surgical or medical intervention for baseline measurements and agree to participate in six follow-up visits of 30-45 minutes in duration during the next two-years. EXCLUSION CRITERIA: Subject chooses to not participate in the study. Subjects are unable to complete the clinical examination tests. Subjects are unable to complete the questionnaires/surveys. Subjects are under age 18.
Total Enrollment: 320
Location and Contact Information:
Warren G. Magnuson Clinical Center (CC) *Recruiting*
Bethesda, Maryland, 20892
United States
Recruiting Patient and Public Liaison Office 1-800-411-1222
Additional Information:
Study ID Numbers: 020045; 02-CC-0045
Study Start Date: November 16, 2001
Record last reviewed: November 16, 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00027118
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4. A Randomized, Placebo-Controlled Trial of BMS-275291 Given Daily for 12 Months to Women with Stage 1c-IIIA Breast Cancer Receiving Adjuvant Chemotherapy and/or Hormonal Therapy
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Morbidity after Diagnosis and Treatment of Breast Cancer Patients
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