Persistent Postmastectomy Pain: Defining the Burden of Disease and the Role of Surgical Reinnervation in Patients With Breast Reconstruction
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 500
- 试验地点
- 7
- 主要终点
- Number of participants with Persistent Postmastectomy Pain
研究概览
简要总结
The purpose of this study is to find out how common persistent postmastectomy pain (PPMP) is among people who have had a mastectomy and breast reconstruction surgery for their breast cancer. The study will also look at how effective regenerative peripheral nerve interface (RPNI) surgery is for reducing pain from neuropathic PPMP after breast reconstruction.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Age ≥18 years
- •History of mastectomy for breast cancer or genetic predisposition to breast cancer
- •History of breast reconstruction with implants and/or autologous tissue
- •At least 6 months of follow-up after reconstruction
- •Patient treated at MSK
排除标准
- •Exchange or revision surgery within 6 months
- •Active medical reason for pain (e.g., infectious, neoplastic, wound related)
- •Greater than 15 years post-reconstruction
研究组 & 干预措施
Postmastectomy Reconstruction Participants
Participants will be postmastectomy reconstruction and >/= 6 months postoperative
干预措施: PROMIS Scale v2.0 - Pain Intensity 3a (Behavioral)
Postmastectomy Reconstruction Participants
Participants will be postmastectomy reconstruction and >/= 6 months postoperative
干预措施: PROMIS 29+2 (Behavioral)
Postmastectomy Reconstruction Participants
Participants will be postmastectomy reconstruction and >/= 6 months postoperative
干预措施: PROMIS Scale v2.0 - Nociceptive Pain Quality 5a (Behavioral)
Postmastectomy Reconstruction Participants
Participants will be postmastectomy reconstruction and >/= 6 months postoperative
干预措施: PROMIS Scale v2.0 - Neuropathic Pain Quality 5a (Behavioral)
结局指标
主要结局
Number of participants with Persistent Postmastectomy Pain
时间窗: up to 6 months
The primary objective is to estimate the prevalence of Persistent Postmastectomy Pain/PPMP in breast cancer survivors treated with mastectomy and reconstruction.
次要结局
未报告次要终点