Clinical Trials (PDQ®)
|No phase specified||Natural history/Epidemiology||Completed||21 and over||NCI, Other||CDR0000616135|
USCF-H452-29674-03, CHR# H452-29674-01C, NCT00769821
RATIONALE: Gathering information from breast cancer survivors about lymphedema; its symptoms and their impact on shoulder, arm, and hand functioning; and quality of life may help doctors learn more about the disease.
PURPOSE: This clinical trial is studying the impact of lymphedema on breast cancer survivors.
Further Study Information
- 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.
- 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
- 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
Trial Lead Organizations/Sponsors
UCSF Helen Diller Family Comprehensive Cancer CenterNational Cancer Institute
|Marylin J. Dodd||Principal Investigator|
Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00769821
ClinicalTrials.gov processed this data on October 17, 2013
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