Tracking the Natural History of Facial Skin Health in Pre and Peri Menopausal Breast Cancer Patients Undergoing Chemotherapy and / or Endocrine Therapies: A Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Percentage of compliance in each of the 4 assessment tools
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Percentage of compliance in each of the 4 assessment tools
时间窗: 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.
次要结局
- 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)