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Completed

NCT Number: NCT06285747

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

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

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Key information

Conditions

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

Sex eligibility

Female

Study type

Observational

Primary location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Non-Interventional Study

Other

Non-Interventional Study

Primary outcomes

  1. Chest wall lymphedema

    Time frame: Baseline

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

  2. 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.

  3. 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.

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Feb 29, 2024
Registry last updated
Aug 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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