Facial Skin Health Tracking Feasibility in Breast Cancer Patients

NCT04035408 | Withdrawn DMC

• 1 other identifier: 18-2444.cc
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer Female

Outcome Measures

Primary Outcomes (1)

• Percentage of compliance in each of the 4 assessment tools

  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.

  3 years

Secondary Outcomes (2)

• Changes in skin health over the duration of the study (4 assessment points)

  3 years

• Changes in body image / skin QOL at end of treatment compared to baseline

  3 years

Study Arms (1)

All subjects

All the enrolled subjects will be considered for the assessment of the primary and secondary outcomes.

Other: Skin health assessment

Interventions

Skin health assessment OTHER

Assess and measure the natural history of facial skin changes in pre and perimenopausal women undergoing chemotherapy and/or endocrine therapy for breast cancer

All subjects

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: pre or perimenopausal woman age 18 or over
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Our baseline skin health self-assessment tool accounts for smoking status, sun exposure, and sunscreen use and this will factor into our assessments/comparison to age and ethnicity matched norms. Sun exposure will likely affect skin age differences at baseline but should not affect the skin aging over the duration of the study.

You may qualify if:

• Provision to sign and date the consent form
• Stated willingness to comply with all study procedures and be available for the duration of the study
• Be a pre or perimenopausal woman age 18 or over
• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Colorado, Denver: lead

Study Sites (1)

University of Colorado Hospital

Aurora, Colorado, 80045, United States

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 10, 2019
• First Posted: July 29, 2019
• Study Start: January 24, 2020
• Primary Completion: February 13, 2023
• Study Completion: February 13, 2023
• Last Updated: September 5, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)