Facial Skin Health Tracking Feasibility in Breast Cancer Patients

NCT ID: NCT04035408

Last Updated: 2023-09-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2020-01-24

Study Completion Date

2023-02-13

Brief Summary

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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

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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.

Conditions

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Breast Cancer Female

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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All subjects

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

Skin health assessment

Intervention Type 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

Interventions

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Skin health assessment

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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University of Colorado, Denver

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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University of Colorado Hospital

Aurora, Colorado, United States

Site Status

Countries

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United States

Other Identifiers

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18-2444.cc

Identifier Type: -

Identifier Source: org_study_id

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