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

August 19, 2025 updated by: Mayo Clinic

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

85

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic in Rochester

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
Non-Interventional Study

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Chest wall lymphedema
Time Frame: Baseline
Assessed using the the MoistureMeterD Compact, handheld device by Delfin Technologies.
Baseline
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.
Baseline
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.
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mayo Clinic

Investigators

  • Principal Investigator: Kayla A. Van Der Weerd, PT, DPT, Mayo Clinic in Rochester

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 28, 2023

Primary Completion (Actual)

June 3, 2025

Study Completion (Actual)

June 3, 2025

Study Registration Dates

First Submitted

February 22, 2024

First Submitted That Met QC Criteria

February 28, 2024

First Posted (Actual)

February 29, 2024

Study Record Updates

Last Update Posted (Estimated)

August 26, 2025

Last Update Submitted That Met QC Criteria

August 19, 2025

Last Verified

August 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 23-004117 (Other Identifier: Mayo Clinic Institutional Review Board)
  • NCI-2024-01191 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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