A Correlational Study: Breast Cancer-Related Chest Wall Lymphedema, Quality of Life, and Shoulder Function
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Mayo Clinic
- Enrollment
- 85
- Locations
- 1
- Primary Endpoint
- Disability of the shoulder - Disabilities of the Arm, Shoulder and Hand (DASH)
Study Overview
Brief Summary
This study evaluates how swelling in the chest following breast cancer treatment may affect patients' quality of life and shoulder function.
Detailed Description
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.
Study Design
- Study Type
- Observational
- Observational Model
- Case Only
- Time Perspective
- Cross Sectional
Eligibility Criteria
- Sex
- Female
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Disability of the shoulder - Disabilities of the Arm, Shoulder and Hand (DASH)
Time Frame: Baseline
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.
Quality of life - Limb Lymphoedema Quality of Life (LymQOL)
Time Frame: Baseline
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.
Chest wall lymphedema
Time Frame: Baseline
Assessed using the the MoistureMeterD Compact, handheld device by Delfin Technologies.
Secondary Outcomes
No secondary outcomes reported