Facial Skin Health Tracking Feasibility in Breast Cancer Patients

Withdrawn

• Conditions: Breast Cancer Female
• Interventions: Other: Skin health assessment

• Registration Number: NCT04035408
• Lead Sponsor: University of Colorado, Denver

Brief Summary

This feasibility study will assess if tracking objective and subjective facial skin changes over time is acceptable to pre and perimenopausal women undergoing chemotherapy and/or endocrine therapy for breast cancer. There is no intervention arm and no control group. Skin health will be assessed through the instruments described below, and subjective data will be collected with self-administered questionnaires.

Detailed Description

There are no studies objectively assessing changes to facial skin health in this population, but tools exist to objectively measure changes thus we have chosen to use those tools to measure skin health. Before embarking on an intervention study showing improvement in skin health and patients' self-image and QOL, we first need to see if 1) it is feasible to measure changes in skin health in this population and 2) if skin health does objectively change over the course of therapy.

Study Timeline

• Study First Submitted: 2019-07-10
• Study First Submitted QC: 2019-07-26
• Study First Posted: 2019-07-29
• Study Start: 2020-01-24
• Primary Completion: 2023-02-13
• Study Completion: 2023-02-13
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-31
• Last Update Posted: 2023-09-05

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Female
• Target Recruitment: Not specified

Inclusion Criteria

1. Provision to sign and date the consent form
2. Stated willingness to comply with all study procedures and be available for the duration of the study
3. Be a pre or perimenopausal woman age 18 or over
4. Be a patient with a new diagnosis of breast cancer who plans to undergo systemic chemotherapy or endocrine therapy, but who has not yet started treatment

Exclusion Criteria

1. Postmenopausal status (one year without a menstrual period)
2. Pregnant women (pregnancy test not required)
3. Prior cancer diagnosis of any type other than breast cancer
4. History of prior treatment with chemotherapy or radiation therapy
5. Chronic skin disease including scleroderma, discoid lupus, atopic dermatitis, rosacea, eczema, or psoriasis
6. Use of a retinoid-based prescription facial skin product within the past 11 month

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
All subjects	Skin health assessment	All the enrolled subjects will be considered for the assessment of the primary and secondary outcomes.

Primary Outcome Measures

Name	Time	Method
Percentage of compliance in each of the 4 assessment tools	3 years	defined as the percentage of patients completing all the scheduled assessments under each assessment tool. The percentage of compliance will be summarized and the associated 90% confidence interval reported. If the percentage of compliance is 80% or higher under each assessment tool, the study will be considered feasible.

Secondary Outcome Measures

Name	Time	Method
Changes in skin health over the duration of the study (4 assessment points)	3 years	Difference in skin health at each assessment from baseline will be calculated which will be divided by the standard deviation of the difference to obtain the effect size of the change at each assessment time post baseline
Changes in body image / skin QOL at end of treatment compared to baseline	3 years	Skindex16 will be used to assess. Skin traits will be rated from 0 (never bothered) to 6 (always bothered). The max score being 96, the least being 0.

Trial Locations

Locations (1)

University of Colorado Hospital; 🇺🇸 Aurora, Colorado, United States