Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
145 participants
OBSERVATIONAL
2007-02-28
2009-02-28
Brief Summary
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PURPOSE: This clinical trial is studying the impact of lymphedema on breast cancer survivors.
Detailed Description
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* To determine the relationship between degree of lymphedema, lymphedema-associated symptoms, and local upper extremity functioning.
* To determine the relationship between degree of lymphedema, lymphedema-associated symptoms, local upper extremity functioning, and overall health-related functioning.
* To determine the relationship between degree of lymphedema, lymphedema-associated symptoms, local upper extremity functioning, overall health-related functioning, and quality of life.
OUTLINE: Patients are stratified according to presence of lymphedema (yes vs no).
Patients complete self-reporting questionnaires to assess the degree of lymphedema using the Norman Questionnaire and Jane M. Armer's Lymphedema and Breast Cancer Questionnaire; lymphedema-associated symptoms using Symptoms in the Affected Breast/Mastectomy site questionnaire, Symptoms in the Shoulder, Arm, or Hand on the Affected Side questionnaire, and General Symptom Experience questionnaire; local upper extremity functioning using hand dominance questionnaire and the Disabilities of the Arm, Shoulder, and Hand (DASH) questionnaire; quality of life (QOL) using the Multidimensional QOL Scale; and comorbidity using the Charleston Comorbidity Scale. Patients undergo a 3.5-hour testing to assess the degree of lymphedema by arm circumference and bioimpedance spectroscopy (BIS); local upper extremity functioning by strength testing, range of movement and neurodynamic testing using a goniometer, a skin examination, skin sensation and sensation at scar using the Semmes-Weinstein Monofilament test, and fine motor control/finger coordination using the Purdue Pegboard, Finger Tapper, and Vibration Threshold; and overall health-related functioning using a graded exercise test.
Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Interventions
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questionnaire administration
assessment of therapy complications
bioimpedance spectroscopy
quality-of-life assessment
Eligibility Criteria
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Inclusion Criteria
* Diagnosis of breast cancer
* No breast cancer on both sides
* No recurrence of breast cancer (local or distant)
* Completed active treatment for breast cancer (i.e., surgery and/or radiotherapy and/or chemotherapy) for ≥ 6 months
* No prior contralateral or bilateral mastectomy
* No pre-existing lymphedema prior to breast cancer diagnosis
* Hormone receptor status not specified
PATIENT CHARACTERISTICS:
* Menopausal status not specified
* Weight \< 300 pounds
* Mentally and physically able to participate
* No current infection or lymphangitis involving the affected arm
* No pre-existing neuromuscular conditions that would affect local upper extremity or overall health-related functioning
* No contraindications to bioimpedance spectroscopy (BIS) testing, including the application of electrode adhesive pads to the skin (i.e., unable to lie supine, allergy to electrode adhesive pads, have sunburn, or have open wound)
* No contraindications to exercise testing as outlined by the American Heart Association and the American College of Sports Medicine
PRIOR CONCURRENT THERAPY:
* See Disease Characteristics
21 Years
FEMALE
No
Sponsors
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National Cancer Institute (NCI)
NIH
University of California, San Francisco
OTHER
Responsible Party
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Principal Investigators
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Marylin J. Dodd, RN, PhD, FAAN
Role: PRINCIPAL_INVESTIGATOR
University of California, San Francisco
Locations
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University of California, San Francisco School of Nursing
San Francisco, California, United States
Countries
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Other Identifiers
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USCF-H452-29674-03
Identifier Type: -
Identifier Source: secondary_id
CDR0000616135
Identifier Type: -
Identifier Source: org_study_id
NCT00501436
Identifier Type: -
Identifier Source: nct_alias