The Impact of Lymphedema on Breast Cancer Survivors

Study Overview
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Brief Summary
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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.

Detailed Description
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OBJECTIVES: 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.

Official Title
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The Impact of Lymphedema on Local and Overall Functioning

Conditions
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Breast Cancer, Cancer Survivor, Lymphedema, Perioperative/Postoperative Complications

Intervention / Treatment
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* Other: questionnaire administration
* Procedure: assessment of therapy complications
* Procedure: bioimpedance spectroscopy
* Procedure: quality-of-life assessment


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: 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

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: questionnaire administration|nan|
|Procedure: assessment of therapy complications|nan|
|Procedure: bioimpedance spectroscopy|nan|
|Procedure: quality-of-life assessment|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Degree of lymphedema as assessed by the Norman Questionnaire, Jane M. Armer's Lymphedema and Breast Cancer Questionnaire, arm circumference, and bioimpedance spectroscopy (BIS) |  | 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 |  | 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]) |  | 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 |  | study visit approximately 5 hours | 
| Quality of life (QOL) as assessed by Multidimensional QOL Scale |  | study visit approximately 5 hours | 
| Comorbidity as assessed by Charleston Comorbidity Scale |  | study visit approximately 5 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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lymphedema, perioperative/postoperative complications, cancer survivor, stage I breast cancer, stage II breast cancer, stage IIIA breast cancer, stage IIIB breast cancer, stage IIIC breast cancer, stage IV breast cancer