Morbidity After Diagnosis and Treatment of Breast Cancer Patients
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.
|Official Title:||A Prospective (Cohort) Study to Identify Factors Affecting Morbidity Following the Diagnosis and Treatment of Patients With Breast Cancer: A Multi-Institutional Study Between the National Institutes of Health (NIH) Rehabilitation Medicine Department (RMD) and the Walter Reed National Military Medical Center (WRNMMC) Breast Care Center (BCC)|
|Study Start Date:||November 2001|
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 300 patients diagnosed with breast cancer before and after medical and surgical treatment compared to a control group of 300 healthy women.
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 five 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 2) 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:
- 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).
- 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
- risk factors for loss of function and disability.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00027118
|Contact: Ellen Levy, PT||(301) firstname.lastname@example.org|
|Contact: Minal Jain, R.P.T.||(301) email@example.com|
|United States, Maryland|
|National Institutes of Health Clinical Center, 9000 Rockville Pike||Recruiting|
|Bethesda, Maryland, United States, 20892|
|Contact: For more information at the NIH Clinical Center contact Patient Recruitment and Public Liaison Office (PRPL) 800-411-1222 ext TTY8664111010 firstname.lastname@example.org|
|National Naval Medical Center||Recruiting|
|Bethesda, Maryland, United States, 20889|
|Principal Investigator:||Minal Jain, R.P.T.||National Institutes of Health Clinical Center (CC)|