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

NCT06285747 | Completed

• 2 other identifiers: 23-004117NCI-2024-01191
• Study Type: observational
• Target: 85
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Breast Carcinoma

Outcome Measures

Primary Outcomes (3)

• Chest wall lymphedema

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

  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.

  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.

  Baseline

Study Arms (1)

Observational

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.

Other: Non-Interventional Study

Interventions

Non-Interventional Study OTHER

Non-Interventional Study

Observational

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Women who have undergone surgical intervention for treatment of breast cancer.

You may qualify if:

• 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

You may not qualify if:

• Previous shoulder injury or known shoulder limitation on affected side

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Kayla A. Van Der Weerd, PT, DPT

  Mayo Clinic in Rochester

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 22, 2024
• First Posted: February 29, 2024
• Study Start: July 28, 2023
• Primary Completion: June 3, 2025
• Study Completion: June 3, 2025
• Last Updated: August 26, 2025

Record last verified: 2025-08

Locations

US (1)