The Impact of Lymphedema on Breast Cancer Survivors

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

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

Clinical Trial Details

NCT number	NCT00769821
Study type	Observational
Source	University of California, San Francisco
Contact
Status	Completed
Phase	N/A
Start date	February 2007
Completion date	February 2009

View Details

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.