The Impact of Lymphedema on Breast Cancer Survivors
|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|
|Primary Completion Date :||February 2009|
|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 ]
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|