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Sponsors and Collaborators: |
National Cancer Institute (NCI) National Naval Medical Center |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00514176 |
RATIONALE: Gathering information about symptoms and disabilities in patients with breast cancer over time may help doctors learn more about the long-term effects of treatment.
PURPOSE: This clinical trial is studying symptoms and disabilities in patients who have undergone treatment for breast cancer.
Condition | Intervention |
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Breast Cancer Long-Term Effects Secondary to Cancer Therapy in Adults |
Other: medical chart review Other: questionnaire administration Other: survey administration Procedure: management of therapy complications Procedure: quality-of-life assessment |
Study Type: | Observational |
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 National Naval Medical Center (NNMC) Breast Care Center (BCC) |
Estimated Enrollment: | 190 |
Study Start Date: | November 2001 |
OBJECTIVES:
OUTLINE: This is a retrospective, case-controlled, multicenter study.
Information about demographics; past medical history; family history; current medical illness and treatment; pain history; and social, physical, and recreational activities is obtained by patient interview and medical record review at baseline and at 1, 3, 6, 9, and 12 months. Patients undergo standard upper body clinical physical exams and testing (including inspection, active and passive range of motion, manual muscle testing, and upper limb lift testing) by a physical therapist at the same time points. Patients also complete the Harvard Alumni Health Study Physical Activity Questionnaire, Upper Limb Disability Questionnaire, and Quality of Life Questionnaire (SF-36v2) at 6 and 12 months.
After completion of study treatment, patients are followed at 5 years.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed breast cancer
Referred to the National Naval Medical Center Breast Care Center (NNMC-BCC) for diagnosis and management (i.e., surgical treatment and radiotherapy or chemotherapy) of breast cancer in 2000-2004
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
Principal Investigator: | Ellen W. Levy | NIH - Warren Grant Magnuson Clinical Center |
Principal Investigator: | Nicole Gergich, MD | National Naval Medical Center |
Study ID Numbers: | CDR0000559843, NCI-02-CC-0044, NCI-020044 |
Study First Received: | August 8, 2007 |
Last Updated: | May 9, 2009 |
ClinicalTrials.gov Identifier: | NCT00514176 History of Changes |
Health Authority: | United States: Federal Government |
long-term effects secondary to cancer therapy in adults stage I breast cancer stage II breast cancer |
stage IIIA breast cancer stage IIIB breast cancer stage IIIC breast cancer |
Skin Diseases Neoplasm Metastasis Breast Neoplasms Breast Diseases |
Neoplastic Processes Neoplasms Pathologic Processes Neoplasms by Site |
Skin Diseases Neoplasm Metastasis Breast Neoplasms Breast Diseases |