Breast CarcinomaNCT06285747
A Correlational Study: Breast Cancer-related Chest Wall Lymphedema, Quality of Life, and Shoulder Function
An observational study of Breast Carcinoma, run by Mayo Clinic at 1 site in United States.
Trial summary
This study evaluates how swelling in the chest following breast cancer treatment may affect patients' quality of life and shoulder function. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Breast Carcinoma
- What is being tested?
- Non-Interventional Study
- How many people
- 85 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Jul 2023to 3 Jun 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: Women who have undergone surgical intervention for treatment of breast cancer.
Who may be able to join
- 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
Who cannot join
- Previous shoulder injury or known shoulder limitation on affected side
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
Official title: 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.
Read the detailed description
PRIMARY OBJECTIVES:
- 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.
- Conditions
- Breast Carcinoma
- Being tested
- Non-Interventional Study
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-Interventional StudyOther
Non-Interventional Study
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Non-Interventional Study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Chest wall lymphedema
Assessed using the the MoistureMeterD Compact, handheld device by Delfin Technologies.
Measured: 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.
Measured: 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.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Feb 2024
- Study start28 Jul 2023
- Primary completion3 Jun 2025
- Study completion3 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CarcinomaStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 85 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kayla A. Van Der Weerd, PT, DPT, Principal investigator, Mayo Clinic in Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06285747
- Sponsor's protocol ID
- 23-004117
- Other IDs
- NCI-2024-01191, 23-004117
- Status last verified
- Aug 2025
- First submitted
- 22 Feb 2024
- Last updated
- 26 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Correlational Study: Breast Cancer-Related Chest Wall Lymphedema, Quality of Life, and Shoulder Function
- ClinicalTrials.gov ID
- NCT06285747
- Acronym / sponsor ID
- 23-004117
- Conditions
- Breast Carcinoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 85 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 28 Jul 2023 (actual)
- Primary completion
- 3 Jun 2025 (actual)
- Study completion
- 3 Jun 2025 (actual)
- First posted
- 29 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observational | – | Other: Non-Interventional StudyPatients 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 may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Women who have undergone surgical intervention for treatment of breast cancer.
Key inclusion criteria (3 listed)
- Women of any age with diagnosis of any type of breast cancer
Key exclusion criteria (1 listed)
- Previous shoulder injury or known shoulder limitation on affected side
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Non-Interventional StudyNon-Interventional Study | Other | Observational |
Primary outcome
Chest wall lymphedema
Time frame: Baseline
Assessed using the the MoistureMeterD Compact, handheld device by Delfin Technologies.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2025.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
Related trials for Breast Carcinoma
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma, Metastatic Breast Cancer
Not yet recruitingObservational study
Comparison of Reliability, Time Cost, and Participant Comfort of Lymphedema Assessments in Upper Extremity
Lymphedema, Upper Extremity Lymphedema
RecruitingPhase 3
A Study of Camrelizumab Plus Chemotherapy in Combination With or Without Famitinib as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (BCTOP-T-N01)
TNBC - Triple-Negative Breast Cancer
RecruitingPhase 3
Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kayla A. Van Der Weerd, PT, DPT principal investigator
Mayo Clinic in Rochester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Carcinoma, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Chest wall lymphedema (time frame: Baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2025.