Protocol Number: 02-CC-0044

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 National Naval Medical Center (NNMC) Breast Care

Number:

02-CC-0044

Summary:

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.

Sponsoring Institute:

Warren G. Magnuson Clinical Center (CC)

Recruitment Detail

Type: Active Accrual Of New Subjects

Gender: Male & Female

Referral Letter Required: Yes

Population Exclusion(s): None

Eligibility Criteria:

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.

Special Instructions: Currently Not Provided

Keywords:

Breast Conserving Surgery

Cancer

Functional Status

Lymphedema

Quality of Life

Recruitment Keywords:

Breast Cancer

Breast Cancer Surgery

Quality of Life

Conditions:

Breast Cancer

Investigational Drug(s):

None

Investigational Device(s):

None

Contacts:

Patient Recruitment and Public Liaison Office
Building 61
10 Cloister Court
Bethesda, Maryland 20892-4754
Toll Free: 1-800-411-1222
TTY: 301-594-9774 (local),1-866-411-1010 (toll free)
Fax: 301-480-9793

Electronic Mail:prpl@mail.cc.nih.gov

Citations:

Patients' descriptions of the experience of receiving radiation therapy

Quality of life for breast cancer patients receiving adjuvant chemotherapy

Women's experiences of lymphedema

• Questions about participating in a study, please contact the Patient Recruitment and Public Liaison Office, CC.
• Technical questions regarding the Clinical Center web site, please contact the Department of Networks and Applications, CC.

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Warren Grant Magnuson Clinical Center (CC)
National Institutes of Health (NIH)
Bethesda, Maryland 20892. Last update: 10/27/2004