Evaluating the Physical and Psychological Effects of Cancer Treatment in Patients With Breast Cancer - Full Text View

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)

Resource links provided by NLM:

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer

U.S. FDA Resources

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
Estimated Primary Completion Date:	May 2013 (Final data collection date for primary outcome measure)

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

Additional Information:

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

No publications provided

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

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

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 November 27, 2009