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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06285747
Enrollment
85
Registered
2024-02-29
Start date
2023-07-28
Completion date
2025-06-03
Last updated
2025-08-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Carcinoma

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. 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.

Interventions

OTHERNon-Interventional Study

Non-Interventional Study

Sponsors

Mayo Clinic
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
FEMALE
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

Design outcomes

Primary

MeasureTime frameDescription
Chest wall lymphedemaBaselineAssessed using the the MoistureMeterD Compact, handheld device by Delfin Technologies.
Quality of life - Limb Lymphoedema Quality of Life (LymQOL)BaselineAssessed 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.
Disability of the shoulder - Disabilities of the Arm, Shoulder and Hand (DASH)BaselineAssessed 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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026