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

Breast Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06285747
• Other study ID #: 23-004117
• Secondary ID: NCI-2024-0119123
• Status: Recruiting
• Start date: July 28, 2023
• Est. completion date: August 1, 2025

Study information

• Verified date: February 2024
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 85
• Est. completion date: August 1, 2025
• Est. primary completion date: August 1, 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Carcinoma
• Breast Neoplasms
• Lymphedema

Intervention

Other:
• Non-Interventional Study
Non-Interventional Study

Locations

Country	Name	City	State
United States	Mayo Clinic in Rochester	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Chest wall lymphedema	Assessed using the the MoistureMeterD Compact, handheld device by Delfin Technologies.	Baseline
Primary	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.	Baseline
Primary	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.	Baseline