Breast Cancer Clinical Trial
Official title:
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
Verified date | August 17, 2016 |
Source | National Institutes of Health Clinical Center (CC) |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
This study will examine the frequency and severity of problems in women with breast cancer
during the first year after 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. Participants will be drawn from patients referred to the National Naval
Medical Center for diagnosis and treatment during 2000-20001.
Participants will be interviewed and their medical records reviewed for past medical history,
history of the present illness and social and recreational history. They will be seen five
times over a 1-year period (initial visit and at 3, 6, 9, and 12 months), for 30-minute
visits, which will include the following:
- Interview about past medical history and present illness, social and recreational
activities, functional independence at work and during activities of daily living.
- Complete health survey and upper limb disability questionnaire; physical activity
questionnaire to be completed at 6 and 12 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, an upper limb
lift test, and measures of upper limb volume and girth.
Status | Completed |
Enrollment | 165 |
Est. completion date | August 17, 2016 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 85 Years |
Eligibility |
- 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 2000-2001, are eligible to participate in the study. Subjects must be over age 18. This age ensures they are 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 five follow-up visits of 30 minutes in duration during the next year. EXCLUSION CRITERIA: Subject's medical records are unavailable and clinical examination forms are incomplete. Subjects choose not to participate in the study. Subjects are unable to complete the questionnaires. Subjects are under age 18. Men are not excluded from the study. |
Country | Name | City | State |
---|---|---|---|
United States | National Institutes of Health Clinical Center, 9000 Rockville Pike | Bethesda | Maryland |
Lead Sponsor | Collaborator |
---|---|
National Institutes of Health Clinical Center (CC) |
United States,
Carter BJ. Women's experiences of lymphedema. Oncol Nurs Forum. 1997 Jun;24(5):875-82. — View Citation
King KB, Nail LM, Kreamer K, Strohl RA, Johnson JE. Patients' descriptions of the experience of receiving radiation therapy. Oncol Nurs Forum. 1985 Jul-Aug;12(4):55-61. — View Citation
Meyerowitz BE, Watkins IK, Sparks FC. Quality of life for breast cancer patients receiving adjuvant chemotherapy. Am J Nurs. 1983 Feb;83(2):232-5. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Upper limb strength | 1,3,6,9,12,60 months | ||
Primary | Range of motion | 1,3,6,9,12,60 month | ||
Primary | Upper limb volume | 1,3,6,9,12,60 month |
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