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| Tracking Information | |||||||||
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| First Received Date ICMJE | August 8, 2007 | ||||||||
| Last Updated Date | October 15, 2009 | ||||||||
| Start Date ICMJE | November 2001 | ||||||||
| Estimated Primary Completion Date | May 2013 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT00513838 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE | |||||||||
| Original Secondary Outcome Measures ICMJE | |||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Evaluating the Physical and Psychological Effects of Cancer Treatment in Patients With Breast Cancer | ||||||||
| Official Title ICMJE | 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) | ||||||||
| Brief Summary | 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. |
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| Detailed Description | OBJECTIVES:
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. |
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| Study Phase | |||||||||
| Study Type ICMJE | Observational | ||||||||
| Study Design ICMJE | |||||||||
| Condition ICMJE |
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| Intervention ICMJE |
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| Study Arms / Comparison Groups | |||||||||
| Publications * | |||||||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 320 | ||||||||
| Completion Date | |||||||||
| Estimated Primary Completion Date | May 2013 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
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| Gender | Female | ||||||||
| Ages | 18 Years and older | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE | |||||||||
| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT ID ICMJE | NCT00513838 | ||||||||
| Responsible Party | |||||||||
| Study ID Numbers ICMJE | CDR0000559847, NCI-02-CC-0045, NCI-020045 | ||||||||
| Study Sponsor ICMJE | National Cancer Institute (NCI) | ||||||||
| Collaborators ICMJE | National Naval Medical Center | ||||||||
| Investigators ICMJE |
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| Information Provided By | National Cancer Institute (NCI) | ||||||||
| Verification Date | July 2009 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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