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Evaluating the Physical and Psychological Effects of Cancer Treatment in Patients With Breast Cancer
This study is currently recruiting participants.
Verified by National Cancer Institute (NCI), December 2008
Sponsors and Collaborators: National Cancer Institute (NCI)
National Naval Medical Center
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00513838
  Purpose

RATIONALE: Gathering health information from patients who received breast cancer treatment may help doctors better understand the effects of treatment.

PURPOSE: This clinical trial is gathering health information from patients who received breast cancer treatment and from those who did not to determine the physical and psychological effects of breast cancer treatment.


Condition Intervention
Breast Cancer
Cancer-Related Problem/Condition
 Procedure: management of therapy complications
Procedure: medical chart review
Procedure: quality-of-life assessment
Procedure: questionnaire administration
Procedure: survey administration

Genetics Home Reference related topics: breast cancer
MedlinePlus related topics: Breast Cancer Cancer
U.S. FDA Resources
Study Type: Observational
Official Title: 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 National Naval Medical Center (NNMC) Breast Care Center (BCC)

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
  • Strengthen the morbidity risk factor model developed in a previous retrospective study

Estimated Enrollment: 320
Study Start Date: November 2001
Detailed Description:

OBJECTIVES:

  • Determine the frequency and severity of symptom distress, pathological conditions, physical impairments, functional limitations, and disabilities during the course of medical treatment.
  • Strengthen the morbidity risk factor model developed in a previous retrospective study.

OUTLINE: This is a 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, 12, 18, and 24 months. Patients undergo standard upper body clinical physical exams (weight, height, range of motion, strength, upper limb lift testing, and arm girth) by a physical therapist at the same time points. Patients also complete the Upper Limb Disability Questionnaire, Quality of Life Questionnaire, and Physical Activity Questionnaire at baseline and at 6, 12, 18, and 24 months.

  Eligibility

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

DISEASE CHARACTERISTICS:

  • Meets one of the following criteria:

    • Histologically confirmed stage I-IIIC breast cancer

      • Referred to the National Naval Medical Center Breast Care Center (NNMC-BCC) for the diagnosis and management (i.e., surgery and radiotherapy or chemotherapy) of breast cancer in 2001-2010
    • Has undergone an excisional biopsy at the NNMC-BCC in 2001-2010 AND is negative for breast cancer
  • Hormone receptor status not specified

PATIENT CHARACTERISTICS:

  • Female
  • Menopausal status not specified
  • Must be post-puberty
  • Able to complete the clinical examination tests and questionnaires/surveys

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00513838

Locations
United States, Maryland
National Naval Medical Center Recruiting
Bethesda, Maryland, United States, 20889-5600
Contact: Peter W. Soballe, MD     301-295-3899     pwsoballe@bethesda.med.navy.mil    
Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office Recruiting
Bethesda, Maryland, United States, 20892-1182
Contact: Clinical Trials Office - Warren Grant Magnusen Clinical Center     888-NCI-1937        
Sponsors and Collaborators
National Cancer Institute (NCI)
National Naval Medical Center
Investigators
Principal Investigator: Ellen W. Levy NIH - Warren Grant Magnuson Clinical Center
Principal Investigator: Peter W. Soballe, MD National Naval Medical Center
  More Information

Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

Study ID Numbers: CDR0000559847, NCI-02-CC-0045, NCI-020045
Study First Received: August 8, 2007
Last Updated: December 31, 2008
ClinicalTrials.gov Identifier: NCT00513838  
Health Authority: Unspecified

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:
Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on January 15, 2009



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