The Impact of Lymphedema on Breast Cancer Survivors
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|ClinicalTrials.gov Identifier: NCT00769821|
Recruitment Status : Completed
First Posted : October 9, 2008
Last Update Posted : December 12, 2012
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.
|Condition or disease||Intervention/treatment|
|Breast Cancer Cancer Survivor Lymphedema Perioperative/Postoperative Complications||Other: questionnaire administration Procedure: assessment of therapy complications Procedure: bioimpedance spectroscopy Procedure: quality-of-life assessment|
- 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.
|Study Type :||Observational|
|Actual Enrollment :||145 participants|
|Official Title:||The Impact of Lymphedema on Local and Overall Functioning|
|Study Start Date :||February 2007|
|Actual Primary Completion Date :||February 2009|
|Actual Study Completion Date :||February 2009|
- Degree of lymphedema as assessed by the Norman Questionnaire, Jane M. Armer's Lymphedema and Breast Cancer Questionnaire, arm circumference, and bioimpedance spectroscopy (BIS) [ Time Frame: study visit approximately 5 hours ]
- Lymphedema-associated symptoms by 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 [ Time Frame: study visit approximately 5 hours ]
- Local upper extremity function by tests & questionnaires (e.g., hand dominance; strength; range of motion & neurodynamics; fine motor control/finger coordination; skin exam; skin & scar sensation [Semmes-Weinstein Monofilament]) [ Time Frame: study visit approximately 5 hours ]
- Overall health-related functioning as assessed by Medical Outcomes Study-Short Form 36 (MOS-SF36), graded exercise test using a treadmill stress test, and cardio-respiratory fitness using peak VO2 [ Time Frame: study visit approximately 5 hours ]
- Quality of life (QOL) as assessed by Multidimensional QOL Scale [ Time Frame: study visit approximately 5 hours ]
- Comorbidity as assessed by Charleston Comorbidity Scale [ Time Frame: study visit approximately 5 hours ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00769821
|United States, California|
|University of California, San Francisco School of Nursing|
|San Francisco, California, United States, 94115|
|Principal Investigator:||Marylin J. Dodd, RN, PhD, FAAN||University of California, San Francisco|