NCT03523078Unknown不适用
Cosmetic Outcome, Patient-reported Outcomes, and Reconstruction-related Complications in Breast Cancer Women Treated With or Without Post-mastectomy Radiation Therapy: Prospective Cohort Study
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- Change from baseline of Breast-Q questionnaire score
研究概览
简要总结
This study aim to investigate the breast reconstruction outcome after mastectomy with or without radiation therapy from the patient's point of view.
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
- •Women who underwent mastectomy and breast reconstruction
- •Good performance status (ECOG 0-1)
排除标准
- •Recurrent breast cancer
- •History of ipsilateral breast irradiation
结局指标
主要结局
Change from baseline of Breast-Q questionnaire score
时间窗: 1 year after the last reconstructive procedures/surgery (allowed plus 8 weeks)
Patient reported outcome measures include psychosocial functioning, patient treatment satisfaction, physical functioning, body image and pain. (Breast-Q survey)
次要结局
- Reconstruction complications(within 1 year after last reconstruction procedures (plus 8 weeks))
研究者
研究点 (1)
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