A Descriptive Study of Vaginal Dilator Use After Pelvic Radiotherapy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 115
- 试验地点
- 5
- 主要终点
- To measure compliance with vaginal dilator use.
研究概览
简要总结
Patient will have radiation to treat the cancer. This treatment can make the vagina both narrower and shorter. That can cause two problems. It can make it harder for the doctor to do a pelvic exam during a follow-up visits. And, it can make sexual intercourse uncomfortable.
We tell women to use a vaginal dilator after radiation to the pelvis. This is standard education. We do not routinely ask women how they do with it. We are doing this study to see if using the dilator as we instruct will help the vagina stretch. The patient will have an examine of the vagina before the start of radiation. We will see what size dilator can fit. The goal of this study is to have the patient be able to use that size dilator within six months after radiation.
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
- 21 Years 至 85 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female with cervical, endometrial, rectal or anal cancer
- •Scheduled to begin one of the following treatments at MSKCC:
- •Definitive external beam radiation therapy
- •Preoperative external beam radiation therapy of followed by surgery
- •Postoperative external beam radiation therapy
- •Definitive external beam radiation therapy with intracavitary brachytherapy (tandem and ring or Syed)± surgery
- •Postoperative intravaginal brachytherapy (once every two weeks times three)
- •≥ or = to 21 years of age
排除标准
- •Women with cervical, endometrial, rectal or anal cancer who are/have:
- •Unable to speak and write English so that it would prohibit them from full participation in the study. Patient education, instruction and questionnaire are validated in English.
- •Mental or physical handicaps that would prohibit them from full participation in the study.
- •Prior radiation to the pelvis.
- •Evidence of metastatic disease.
结局指标
主要结局
To measure compliance with vaginal dilator use.
时间窗: conclusion of study
To examine the effect of dilator use in minimizing vaginal stenosis so that patients are able to use the pre-radiation baseline dilator size 6 months after starting dilator use.
时间窗: conclusion of study
次要结局
- To measure vaginal symptoms related to vaginal stenosis during vaginal dilation over 6 months after starting dilator use.(conclusion of study)
- To explore reasons for non-compliance with use of dilators.(conclusion of study)
- To explore patient-reported self-efficacy as it relates to the use of the vaginal dilator.(conclusion of study)