Ignite Creation Date:
2024-05-11 @ 8:30 AM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06401889
Status:
RECRUITING
Last Update Posted:
2024-06-28
First Post:
2024-05-02
Brief Title:
Enhancing Skin Appearance and Quality of Life in Breast Cancer Survivors on Aromatase Inhibitor Therapy
Sponsor:
Mayo Clinic
Organization:
Mayo Clinic
Study Overview
Official Title:
Enhancing Skin Appearance and Quality of Life in Breast Cancer Survivors on Aromatase Inhibitor Therapy
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 changes in skin quality and self-esteem among breast cancer patients who are initiating aromatase inhibitor therapy
Detailed Description:
PRIMARY OBJECTIVES
I Evaluate the incidence and severity of skin quality changes after initiation of Aromatase Inhibitor AI therapy in breast cancer BC survivors through use of Canfield Sciences VISIA-CA technology and facial skin assessment photography
II Evaluate impact of AI therapy on patient-reported self-esteem and dermatology related life quality through validated patient reported outcome measures
III Assess for objective improvements in skin quality measurements with VISIA-CA after skincare intervention with aesthetician consultation
IV Measure changes in patient-reported self-esteem and dermatology related life quality following skincare intervention
OUTLINE This is an observational study
Patients complete surveysquestionnaires undergo skin measurement with the VISIA CA device undergo facial skin photography and attend consultations with an aesthetician on study
I Evaluate the incidence and severity of skin quality changes after initiation of Aromatase Inhibitor AI therapy in breast cancer BC survivors through use of Canfield Sciences VISIA-CA technology and facial skin assessment photography
II Evaluate impact of AI therapy on patient-reported self-esteem and dermatology related life quality through validated patient reported outcome measures
III Assess for objective improvements in skin quality measurements with VISIA-CA after skincare intervention with aesthetician consultation
IV Measure changes in patient-reported self-esteem and dermatology related life quality following skincare intervention
OUTLINE This is an observational study
Patients complete surveysquestionnaires undergo skin measurement with the VISIA CA device undergo facial skin photography and attend consultations with an aesthetician 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?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-2024-03468 | REGISTRY | None | None |
| 22-002971 | OTHER | None | None |
| MC220302 | OTHER | Mayo Clinic in Florida | None |