|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| Sponsor: | National Cancer Institute (NCI) |
|---|---|
| Collaborator: |
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 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: | 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) |
| Estimated Enrollment: | 320 |
| Study Start Date: | November 2001 |
| Estimated Primary Completion Date: | May 2013 (Final data collection date for primary outcome measure) |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Meets one of the following criteria:
Histologically confirmed stage I-IIIC breast cancer
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
Contacts and 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 | |
| Principal Investigator: | Ellen W. Levy | NIH - Warren Grant Magnuson Clinical Center |
| Principal Investigator: | Peter W. Soballe, MD | National Naval Medical Center |
More Information
| Study ID Numbers: | CDR0000559847, NCI-02-CC-0045, NCI-020045 |
| Study First Received: | August 8, 2007 |
| Last Updated: | October 15, 2009 |
| ClinicalTrials.gov Identifier: | NCT00513838 History of Changes |
| Health Authority: | Unspecified |
|
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 |
|
Neoplastic Processes Neoplasms Pathologic Processes Neoplasms by Site |
Skin Diseases Neoplasm Metastasis Breast Neoplasms Breast Diseases |