Morbidity After Diagnosis and Treatment of Breast Cancer Patients

Completed

Conditions studied: Breast Cancer, Shoulder, Lymphedema, Fatigue

In brief

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.

Key facts

Study ID
NCT00027118
Run by
National Institutes of Health Clinical Center (CC)
People needed
326
Starts
2001-11-16
Expected to finish
2016-08-17
Last updated by the study team
2019-12-16

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: accepted.

You may not qualify if…

Where it is running

Full record on ClinicalTrials.gov

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