Registry for Analysis of Impact of Radiation Dose to Skin on Cosmetic Outcome and Patient-reported Outcomes in Patients With Breast Cancer Treated With Radiation Therapy
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- Change of cosmesis from baseline
研究概览
简要总结
The goal of this observational study is to learn about toxicities and cosmetic outcomes in breast cancer patients treated with hypofractionated radiotherapy.
The main question it aims to answer are:
- Changes in breast skin
- Factors related to breast skin changes
- Patient-reported outcomes
- Cosmetic outcomes
Participants will be assessed by multi-dimensional methods before and after radiotherapy:
- Photographs
- Fibrometer
- Questionnaires (BREAST-Q)
- CTCAE version 4.03 evaluated by treating physicians
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 85 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Breast cancer treated with curative surgery
排除标准
- •History of thoracic radiation therapy
结局指标
主要结局
Change of cosmesis from baseline
时间窗: 5 year after radiation therapy
Evaluated by two blinded independent physicians based on photographs
Change of patient-reported outcome from baseline
时间窗: 5 year after radiation therapy
BREAST-Q questionnaire is used to evaluate patient-reported outcome.
Change of fibrosis from baseline
时间窗: 5 year after radiation therapy
Evaluated using fibrometer measuring both breast
Physician assessed toxicity
时间窗: 5 year after radiation therapy
CTCAE version 4.03 is used to evaluate physician-assessed toxicities.
Change of cosmesis from baseline
时间窗: After 2-3 weeks after the start of radiation therapy (During radiation therapy)
Evaluated by two blinded independent physicians based on photographs
Change of cosmesis from baseline
时间窗: 2-3 weeks after the completion of radiation therapy
Evaluated by two blinded independent physicians based on photographs
Change of cosmesis from baseline
时间窗: 6 months after radiation therapy
Evaluated by two blinded independent physicians based on photographs
Change of cosmesis from baseline
时间窗: 1 year after radiation therapy
Evaluated by two blinded independent physicians based on photographs
Change of cosmesis from baseline
时间窗: 2 year after radiation therapy
Evaluated by two blinded independent physicians based on photographs
Change of fibrosis from baseline
时间窗: After 2-3 weeks after the start of radiation therapy (During radiation therapy)
Evaluated using fibrometer measuring both breast
Change of fibrosis from baseline
时间窗: 2-3 weeks after the completion of radiation therapy
Evaluated using fibrometer measuring both breast
Change of fibrosis from baseline
时间窗: 6 months after radiation therapy
Evaluated using fibrometer measuring both breast
Change of fibrosis from baseline
时间窗: 1 year after radiation therapy
Evaluated using fibrometer measuring both breast
Change of fibrosis from baseline
时间窗: 2 year after radiation therapy
Evaluated using fibrometer measuring both breast
Change of patient-reported outcome from baseline
时间窗: After 2-3 weeks after the start of radiation therapy (During radiation therapy)
BREAST-Q questionnaire is used to evaluate patient-reported outcome.
Change of patient-reported outcome from baseline
时间窗: 2-3 weeks after the completion of radiation therapy
BREAST-Q questionnaire is used to evaluate patient-reported outcome.
Change of patient-reported outcome from baseline
时间窗: 6 months after radiation therapy
BREAST-Q questionnaire is used to evaluate patient-reported outcome.
Change of patient-reported outcome from baseline
时间窗: 1 year after radiation therapy
BREAST-Q questionnaire is used to evaluate patient-reported outcome.
Change of patient-reported outcome from baseline
时间窗: 2 year after radiation therapy
BREAST-Q questionnaire is used to evaluate patient-reported outcome.
Physician assessed toxicity
时间窗: After 2-3 weeks after the start of radiation therapy
CTCAE version 4.03 is used to evaluate physician-assessed toxicities.
Physician assessed toxicity
时间窗: 2-3 weeks after the completion of radiation therapy
CTCAE version 4.03 is used to evaluate physician-assessed toxicities.
Physician assessed toxicity
时间窗: 6 months after radiation therapy
CTCAE version 4.03 is used to evaluate physician-assessed toxicities.
Physician assessed toxicity
时间窗: 1 year after radiation therapy
CTCAE version 4.03 is used to evaluate physician-assessed toxicities.
Physician assessed toxicity
时间窗: 2 year after radiation therapy
CTCAE version 4.03 is used to evaluate physician-assessed toxicities.
次要结局
未报告次要终点
研究者
Haeyoung Kim
Associate professor
Samsung Medical Center