Morbidity After Diagnosis and Treatment of Breast Cancer Patients
|First Received Date ICMJE||November 20, 2001|
|Last Updated Date||November 11, 2014|
|Start Date ICMJE||November 2001|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE||Not Provided|
|Original Primary Outcome Measures ICMJE||Not Provided|
|Change History||Complete list of historical versions of study NCT00027118 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE||Not Provided|
|Original Secondary Outcome Measures ICMJE||Not Provided|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Morbidity After Diagnosis and Treatment of Breast Cancer Patients|
|Official Title ICMJE||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)|
This study will examine the frequency and severity of problems in women with breast cancer for 2 years following initial medical treatment, including:
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:
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:
|Study Type ICMJE||Observational|
|Study Design ICMJE||Not Provided|
|Target Follow-Up Duration||Not Provided|
|Sampling Method||Not Provided|
|Study Population||Not Provided|
|Condition ICMJE||Breast Cancer|
|Intervention ICMJE||Not Provided|
|Study Group/Cohort (s)||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Recruiting|
|Estimated Enrollment ICMJE||500|
|Completion Date||Not Provided|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
Population/Subjects: Individuals with 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.
Healthy female individuals will be controls.
Subjects must be over 18 years of age 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.
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.
|Ages||18 Years and older|
|Accepts Healthy Volunteers||Yes|
|Location Countries ICMJE||United States|
|NCT Number ICMJE||NCT00027118|
|Other Study ID Numbers ICMJE||020045, 02-CC-0045|
|Has Data Monitoring Committee||Not Provided|
|Responsible Party||National Institutes of Health Clinical Center (CC)|
|Study Sponsor ICMJE||National Institutes of Health Clinical Center (CC)|
|Collaborators ICMJE||Not Provided|
|Information Provided By||National Institutes of Health Clinical Center (CC)|
|Verification Date||March 2014|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP