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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2024-01191 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| 23-004117 | Other Identifier | Mayo Clinic Institutional Review Board |
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This study evaluates how swelling in the chest following breast cancer treatment may affect patients' quality of life and shoulder function.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Non-Interventional Study | Other | Non-Interventional Study |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Women of any age with diagnosis of any type of breast cancer
Exclusion Criteria:
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Women who have undergone surgical intervention for treatment of breast cancer.
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| Name | Affiliation | Role |
|---|---|---|
| Kayla A. Van Der Weerd, PT, DPT | Mayo Clinic in Rochester | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic in Rochester | Rochester | Minnesota | 55905 | United States |
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| Label | URL |
|---|---|
| Mayo Clinic Clinical Trials | View source |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| D017437 |
| Skin and Connective Tissue Diseases |