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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| All subjects | All the enrolled subjects will be considered for the assessment of the primary and secondary outcomes. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in skin health over the duration of the study (4 assessment points) | 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 | 3 years |
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Inclusion Criteria:
Exclusion Criteria:
pre or perimenopausal woman age 18 or over
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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.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Colorado Hospital | Aurora | Colorado | 80045 | United States |
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| Changes in body image / skin QOL at end of treatment compared to baseline |
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. |
| 3 years |