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Symptoms and Disabilities in Patients Who Have Undergone Treatment for Breast Cancer
This study is ongoing, but not recruiting participants.
First Received: August 8, 2007   Last Updated: May 9, 2009   History of Changes
Sponsors and Collaborators: National Cancer Institute (NCI)
National Naval Medical Center
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00514176
  Purpose

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
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)

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Frequency and severity of symptom distress, pathological conditions, physical impairments, functional limitations, and disabilities
  • Level of physical impairment and physical performance in patients who have lost independence in function
  • Risk of developing physical impairments, loss of independence of function, and disability

Estimated Enrollment: 190
Study Start Date: November 2001
Detailed Description:

OBJECTIVES:

  • To determine the frequency and severity of symptom distress (i.e., fatigue, pain [including chronic pain, aching, weakness, burning, tingling, and numbness], anxiety, and depression) and pathological conditions (i.e., adhesive capsulitis, weakness and atrophy, neuropathy, scar/skin adhesions, and lymphedema) in patients with breast cancer.
  • To determine the frequency and severity of physical impairments (i.e., diminished upper extremity and trunk range of motion/flexibility, strength, coordination, and increased girth).
  • To determine the frequency and severity of functional limitations and disabilities during the course of medical treatment (i.e., loss of independence in or ability to perform routine activities of daily living [ADLs] [i.e., grooming, bathing, dressing, driving an automobile, and, in some cases, returning to regular work], and recreational and social activities).
  • To determine the level of physical impairment and physical performance in patients who have lost independence in function (i.e., ADLs).
  • To determine which patients are at higher risk for development of these impairments, loss of independence of function, and disability.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed breast cancer

    • Stage I-III disease
  • 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

    • Seen at the NNMC-BCC Physical Therapy Department for a baseline, pre-treatment examination in 2000-2004
  • Hormone receptor status not specified

PATIENT CHARACTERISTICS:

  • Female
  • Menopausal status not specified
  • Able to complete questionnaires

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00514176

Sponsors and Collaborators
National Naval Medical Center
Investigators
Principal Investigator: Ellen W. Levy NIH - Warren Grant Magnuson Clinical Center
Principal Investigator: Nicole Gergich, MD National Naval Medical Center
  More Information

Additional Information:
No publications provided

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

Keywords provided by National Cancer Institute (NCI):
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

Study placed in the following topic categories:
Skin Diseases
Neoplasm Metastasis
Breast Neoplasms
Breast Diseases

Additional relevant MeSH terms:
Neoplastic Processes
Neoplasms
Pathologic Processes
Neoplasms by Site
Skin Diseases
Neoplasm Metastasis
Breast Neoplasms
Breast Diseases

ClinicalTrials.gov processed this record on September 04, 2009