A Correlational Study: Breast Cancer-related Chest Wall Lymphedema, Quality of Life, and Shoulder Function

Mayo Clinic85 enrolled

Overview

This study evaluates how swelling in the chest following breast cancer treatment may affect patients' quality of life and shoulder function.

PRIMARY OBJECTIVES: I. Determine if there is a correlation to Delfin Moisture Meter Compact D reading and quality of life as measured by the LymQOL-midline. II. Determine if there is a correlation to Delfin Moisture Meter Compact D reading and DASH measure of shoulder function. III. Determine how the presence of chest wall lymphedema as determined by physical exam may affect an individual's quality of life as measured by the LymQOL-midline assessment. IV. Determine how the presence of chest wall lymphedema as determined by physical exam may shoulder function on the effected side, as measured by the Disabilities of the Arm, Shoulder, and Hand questionnaire. OUTLINE: This is an observational study. Patients complete questionnaires and undergo chest wall and breast lymphedema measurements by clinical assessment and using the Delfin Moisture Meter D Compact and have their medical records reviewed on study.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Breast Carcinoma

Interventions

Non-Interventional StudyOTHER

Non-Interventional Study

Eligibility

Sex: FEMALE

Medical Language ↔ Plain English

Inclusion Criteria: * Women of any age with diagnosis of any type of breast cancer * Breast cancer on unilateral or bilateral side * Surgical intervention for treatment of breast cancer Exclusion Criteria: * Previous shoulder injury or known shoulder limitation on affected side

Locations (1)

Mayo Clinic in Rochester

Rochester, Minnesota, United States

Outcomes

Primary Outcomes

Chest wall lymphedema

Assessed using the the MoistureMeterD Compact, handheld device by Delfin Technologies.

Time frame: Baseline

Quality of life - Limb Lymphoedema Quality of Life (LymQOL)

Assessed using the Limb Lymphoedema Quality of Life (LymQOL) Tool, a patient reported outcome measure comprised of 20 questions. Responses for questions 1-19 are: not at all, a little, quite a bit, a lot, or N/A with free-text fields for participants to include examples. Question 20 is answered on a 1-10 scale. Higher scores generally indicate better quality of life.

Time frame: Baseline

Disability of the shoulder - Disabilities of the Arm, Shoulder and Hand (DASH)

Assessed using the Disabilities of the Arm, Shoulder and Hand (DASH) Questionnaire. Questions are answered with a scale of 1-5 with varying values assigned to the numbers (e.g., not at all, slightly, moderately, quite a bit, extremely). Higher scores indicate greater disability.

Time frame: Baseline

Data from ClinicalTrials.gov

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