Early Pelvic Floor Physical Therapy for Women Undergoing Pelvic Radiation for Gynecologic Malignancies
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- Evaluate fecal incontinence via EORTC-QLQ CX24 validated survey
研究概览
简要总结
This is a single arm phase II study in which 28 patients who will be undergoing definitive pelvic external beam radiation therapy for cervical cancer will receive pelvic floor physical therapy 4 weeks after completing radiation therapy.
详细描述
This is a single arm phase II study in which 28 patients who will be undergoing definitive pelvic external beam radiation therapy for cervical cancer will receive pelvic floor physical therapy 4 weeks after completing radiation therapy. The objective is to determine the rate of fecal incontinence at 3 months after RT in women undergoing pelvic radiation for gynecologic malignancies. The primary endpoint of this study is the rate of fecal incontinence at 3 months after RT utilizing the EORTC-QLQ CX24 validated survey. A score of 1 or higher will be classified as having incontinence.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 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
- 否
入选标准
- •Participants must be female.
- •Patients must be 18 years old or older.
- •Any patient with invasive cervical cancer who is planned for definitive chemoradiation.
- •Plan to receive a minimum dose of 45Gy to pelvis per investigator.
- •Willing to undergo pelvic floor physical therapy.
排除标准
- •Any previous therapeutic pelvic radiation.
- •Non-English speaking.
研究组 & 干预措施
Pelvic floor physical therapy
Patients who will be undergoing definitive pelvic external beam radiation therapy for cervical cancer will receive pelvic floor physical therapy 4 weeks after completing radiation therapy.
干预措施: Pelvic floor physical therapy (Procedure)
结局指标
主要结局
Evaluate fecal incontinence via EORTC-QLQ CX24 validated survey
时间窗: 3 months after Radiation Therapy Treatment
To determine the rate of fecal incontinence at 3 months after RT in women undergoing pelvic radiation for gynecologic malignancies. The primary endpoint of this study is the rate of fecal incontinence at 3 months after RT utilizing the EORTC-QLQ CX24 validated survey. A score of 1 or higher will be classified as having incontinence.
次要结局
- Rates of urinary incontinence via EORTC-QLQ CX24(3 months after Radiation Therapy Treatment)
- Sexual symptoms via EORTC-QLQ CX24(3 months after Radiation Therapy Treatment)
- QOL as obtained from the EORTC-QLQ CX24(3 months after Radiation Therapy Treatment)
- Compliance rates with recommended standard of care schedule of dilator via self reports(3 months after Radiation Therapy Treatment)
- Evaluate changes in pelvic floor muscle function using the validated Brink scale(At Baseline and at 3 months after Radiation Therapy Treatment)
研究者
Sarah Sittenfeld
Principal Investigator
University of Cincinnati