Breast Cancer Clinical Trial

The Impact of Lymphedema on Breast Cancer Survivors

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.

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Full 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.

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Eligibility Criteria

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

Study is for people with:

Breast Cancer

Estimated Enrollment:

145

Study ID:

NCT00769821

Recruitment Status:

Completed

Sponsor:

University of California, San Francisco

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There is 1 Location for this study

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University of California, San Francisco School of Nursing
San Francisco California, 94115, United States

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Estimated Enrollment:

145

Study ID:

NCT00769821

Recruitment Status:

Completed

Sponsor:


University of California, San Francisco

How clear is this clinincal trial information?

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