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

Recruiting

• Conditions: Breast Carcinoma
• Interventions: Other: Non-Interventional Study

• Registration Number: NCT06285747
• Lead Sponsor: Mayo Clinic

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.

Study Timeline

• Study Start: 2023-07-28
• Study First Submitted: 2024-02-22
• Study First Submitted QC: 2024-02-28
• Study First Posted: 2024-02-29
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-04
• Last Update Posted: 2025-03-06
• Primary Completion: 2025-08-01
• Study Completion: 2025-08-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 85

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Observational	Non-Interventional 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.

Primary Outcome Measures

Name	Time	Method
Disability of the shoulder - Disabilities of the Arm, Shoulder and Hand (DASH)	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)	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	Baseline	Assessed using the the MoistureMeterD Compact, handheld device by Delfin Technologies.

Trial Locations

Locations (1)

Mayo Clinic in Rochester; 🇺🇸 Rochester, Minnesota, United States