Anatomic Stage 0 Breast Cancer AJCC v8, Anatomic Stage I Breast Cancer AJCC v8, Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage III Breast Cancer AJCC v8, Breast Adenocarcinoma, Estrogen Receptor-Positive Breast Carcinoma, Progesterone Receptor-Positive Breast Carcinoma
Conditions
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 surveys/questionnaires, undergo skin measurement with the VISIA CA device, undergo facial skin photography, and attend consultations with an aesthetician on study.
Interventions
OTHERNon-Interventional Study
Non-interventional study
Sponsors
Mayo Clinic
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* \* Female ≥ 18 years * Postmenopausal women suitable to receive aromatase inhibitor as per physician's discretion * Histologically confirmed adenocarcinoma of the breast stage 0-III with estrogen receptor (ER) and/or progesterone receptor (PR) positive per American Society of Clinical Oncology (ASCO)/ College of American Pathologists (CAP) guideline and any human epidermal growth factor receptor 2 (HER2) * Patients must not have received any prior chemotherapy or endocrine therapy for their current breast cancer. Patients who received tamoxifen or raloxifene or another agent for prevention of breast cancer may be included * Patients willing to avoid any facial procedures including facials, neurotoxin injections, fillers, or lasers during study period * Willing and able to provide consent
Exclusion criteria
* \* Patients who have previously taken AIs * Patients using prescription tretinoin, neurotoxin injections, fillers, facial lasers, microneedling, or facials within 6 months of study consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in skin quality | Up to 6 months | Changes in skin quality measured as incidence and severity of skin quality changes using VISIA-CA technology (skin analysis imaging system) and facial skin assessment photography. |
Countries
United States
Contacts
CONTACTClinical Trials Referral Office
PRINCIPAL_INVESTIGATORLeila M. Tolaymat, M.D.
Mayo Clinic
Outcome results
None listed