NCT00769821

The Impact of Lymphedema on Breast Cancer Survivors

The Impact of Lymphedema on Local and Overall Functioning

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 145 (actual)
• Sponsor: University of California, San Francisco · Academic / Other
• Sex: Female
• Age: 21 Years
• Healthy volunteers: Not accepted

Summary

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

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.

Conditions

• Breast Cancer
• Cancer Survivor
• Lymphedema
• Perioperative/Postoperative Complications

Interventions

Type	Name	Description
OTHER	questionnaire administration
PROCEDURE	assessment of therapy complications
PROCEDURE	bioimpedance spectroscopy
PROCEDURE	quality-of-life assessment

Timeline

• Start date: 2007-02-01
• Primary completion: 2009-02-01
• Completion: 2009-02-01
• First posted: 2008-10-09
• Last updated: 2012-12-12

Locations

1 site across 1 country: United States