Pre-Rehabilitation for Female Patients Undergoing Pelvic Radiotherapy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 5
- 主要终点
- Feasability of implementation of pre-rehabilitation to radiotherapy
研究概览
简要总结
The purpose of this study is to examine the feasibility of adding pre-rehabilitation pelvic health physical therapy to standard of care radiation therapy treatment plan for female patients who have been diagnosed with cervical, vaginal, vulvar, uterine, or anal cancer and are a candidate for curative pelvic radiation with external beam. Participants will receive education on using a vaginal dilator for use during treatment and complete questionnaires looking at pain and sexual function.
详细描述
Because of the increasing survivorship rate, there is a need for research addressing the post-treatment side effects of pelvic pain and dyspareunia, due to the significant impact these side effects have on patients' quality of life. Current best practice from trained pelvic health physical therapists for addressing dyspareunia and pelvic pain due to vaginal stenosis after radiation therapy, is vaginal dilation. Vaginal dilators are cone shaped durable medical equipment that are inserted into the vagina with lubricant, to assist in patency of the vaginal canal and stretching of the pelvic floor muscles.
The primary objective of this pilot clinical trial is to assess the feasibility of implementing a collaborative, coordinated, and multidisciplinary initiative between radiation oncology and pelvic health physical therapy to answer the following questions: 1) What are the barriers and facilitators to the implementation of a pre-rehabilitation service for gynecological and female anal cancer patients undergoing pelvic radiation and 2) What is the potential clinical value of adding pre-rehabilitative pelvic health services, with an emphasis on vaginal dilator education and use, to the gynecological and female anal cancer radiation setting, in collaboration with radiation oncology staff, as a means of reducing pelvic pain and dyspareunia?
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
- •≥ 18 years old at the time of informed consent
- •Ability to provide written informed consent and HIPAA authorization
- •Primary diagnosis of cervical, vaginal, vulvar, uterine, or anal cancer
- •Candidate for curative pelvic radiation with external beam, with or without brachytherapy, per radiation oncologist's discretion
- •Can have prior and/or current modalities of treatment to address diagnosis including surgery and chemotherapy
- •Can receive radiation at any facility provided patient is able to perform Physical Therapy visits at IUH North/Schwarz Cancer Center
排除标准
- •Major medical illnesses or psychiatric impairments, which in the investigator's opinion will prevent administration or completion of the protocol therapy and/or interfere with follow-up.
- •Not a candidate for curative radiation therapy per radiation oncologist's discretion
- •Prior radiation therapy to the pelvis
- •Women who are pregnant or nursing
结局指标
主要结局
Feasability of implementation of pre-rehabilitation to radiotherapy
时间窗: Baseline to 4 months
The number of Female Sexual Function Index questionnaires will be recorded as completed, incomplete or not attempted. Reasons for submitting incomplete questionnaires or not submitting a questionnaire will be recorded.
次要结局
- Average score on the Visual Pain Rating Scale.(Immediately upon radiation completion, 4 weeks, 6 weeks, 8 weeks, 12 weeks, and 16 weeks post radiation)
- Evaluate female sexual function based on questionnaire responses(Immediately upon radiation completion, 4 weeks, 6 weeks, 8 weeks, 12 weeks, and 16 weeks post radiation)
- Percentage of adherence to dilator use(Immediately upon radiation completion, 4 weeks, 6 weeks, 8 weeks, 12 weeks, and 16 weeks post radiation)
研究者
Namita Agrawal
Assistant Professor of Radiation Oncology
Indiana University