Ignite Creation Date:
2024-05-06 @ 8:11 PM
Last Modification Date:
2024-10-26 @ 3:22 PM
Study NCT ID:
NCT06285747
Status:
RECRUITING
Last Update Posted:
2024-02-29
First Post:
2024-02-22
Brief Title:
A Correlational Study Breast Cancer-related Chest Wall Lymphedema Quality of Life and Shoulder Function
Sponsor:
Mayo Clinic
Organization:
Mayo Clinic
Study Overview
Official Title:
A Correlational Study Breast Cancer-Related Chest Wall Lymphedema Quality of Life and Shoulder Function
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
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 individuals 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
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 individuals 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-2024-01191 | REGISTRY | None | None |
| 23-004117 | OTHER | Mayo Clinic Institutional Review Board | None |