The Impact of Lymphedema on Breast Cancer Survivors

Completed

• Conditions: Breast Cancer; Cancer Survivor; Lymphedema; Perioperative/Postoperative Complications

• Registration Number: NCT00769821
• Lead Sponsor: University of California, San Francisco

Brief 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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2007-02
• Study First Submitted: 2008-10-08
• Study First Submitted QC: 2008-10-08
• Study First Posted: 2008-10-09
• Primary Completion: 2009-02
• Study Completion: 2009-02
• Status Verified: 2012-12
• Last Update Submitted: 2012-12-11
• Last Update Posted: 2012-12-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 145

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

University of California, San Francisco School of Nursing; 🇺🇸 San Francisco, California, United States