Impact of 5-fraction Stereotactic Partial Breast Irradiation and Whole Breast Irradiation on Cosmetic Outcome and Patient-reported Outcomes in Early-stage Breast Cancer
试验速览
- 阶段
- 不适用
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Change of patient reported psychosocial functioning score
研究概览
简要总结
This study aim to investigate the effect of 5-fraction stereotactic partial breast irradiation and whole breast irradiation on patient-reported outcomes, cosmetic outcome, and breast tissue fibrosis in early-stage breast cancer.
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
- 20 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Pathologically confirmed invasive breast carcinoma or ductal carcinoma in situ (DCIS)
- •Women who underwent breast-conservating surgery and have a plan to undergoing partial or whole breast irradiation
- •Good performance status (ECOG 0-1)
排除标准
- •Recurrent breast cancer
- •History of ipsilateral breast irradiation
- •Positive resection margin status after breast surgery
结局指标
主要结局
Change of patient reported psychosocial functioning score
时间窗: 2 year after radiotherapy (allowed to plus 8 weeks)
Patient reported psychosocial functioning measured in 7 point Likert scale
Change of patient reported patient treatment satisfaction score
时间窗: 2 year after radiotherapy (allowed to plus 8 weeks)
Patient reported patient treatment satisfaction measured in 7 point Likert scale
Change of patient reported physical functioning score
时间窗: 2 year after radiotherapy (allowed to plus 8 weeks)
Patient reported physical functioning measured in 7 point Likert scale
Change of patient reported body image score
时间窗: 2 year after radiotherapy (allowed to plus 8 weeks)
Patient reported body image score measured in 7 point Likert scale
Change of breast cosmesis measures (excellent/good/poor)
时间窗: 2 year after radiotherapy (allowed to plus 8 weeks)
breast cosmesis result is measures by BCCT.core (Breast Cancer Conservative Treatment cosmetic results) software
Change of breast-tissue fibrosis measures (gram)
时间窗: 2 year after radiotherapy (allowed to plus 8 weeks)
breast-tissue fibrosis is measured by tissue compliance meter device.
次要结局
- Incidence of Radiotherapy-related complications(2 year after radiotherapy (allowed to plus 8 weeks))