Morbidity After Diagnosis and Treatment of Breast Cancer Patients
| Status: | Completed |
|---|---|
| Conditions: | Breast Cancer, Cancer, Other Indications, Orthopedic |
| Therapuetic Areas: | Oncology, Orthopedics / Podiatry, Other |
| Healthy: | No |
| Age Range: | 18 - 85 |
| Updated: | 4/6/2019 |
| Start Date: | November 16, 2001 |
| End Date: | August 17, 2016 |
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:
- 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.
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.
Patients and healthy participants will undergo an interview at the beginning of the study and
1,3,6,9, 12, 18 and 24 months and answer questions about their medical history; family
history; current problem and treatment; pain history; and social, physical and recreational
activities. At the visit, they will also undergo an upper body physical exam by a physical
therapist. Patients and the healthy participants will also fill out questionnaires about arm
disability, quality of life, and physical activity at the beginning of the study and at 12,
18, and 24 months.
1,3,6,9, 12, 18 and 24 months and answer questions about their medical history; family
history; current problem and treatment; pain history; and social, physical and recreational
activities. At the visit, they will also undergo an upper body physical exam by a physical
therapist. Patients and the healthy participants will also fill out questionnaires about arm
disability, quality of life, and physical activity at the beginning of the study and at 12,
18, and 24 months.
- INCLUSION CRITERIA:
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.
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.
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