Randomized Feasibility Study of Dilator Use and an Educational Program to Increas

描述（由申请人提供）：子宫内膜癌是美国最常见的妇科恶性肿瘤，68%至83%的女性（II期或III期辅助阴道近距离放射治疗（VBT））存活5年。在接受VBT治疗的患者中，高达65%的患者可能会发生阴道狭窄或缩短，并干扰正常的性功能。这项R21试点研究将提供招募女性参与阴道扩张器使用试验（一种用于在VBT后打破阴道粘连的工具）的可行性的初步数据，并测试一种增加干预依从性的方法。可行性和依从性是未来研究阴道扩张器在维持VBT后阴道长度和可能的性健康方面的有效性的必要前提。本研究还将为一项更大规模的使用阴道扩张器在VBT后维持阴道长度的随机试验提供效应量计算。研究VBT后的阴道扩张是必要的，因为它是一种侵入性的长期干预，是一种常见的推荐做法，但几乎没有经验证据。这项研究的结果将为未来的研究提供基础，这些研究可能对癌症治疗后维持性健康的行为和设备干预具有临床意义。本研究的初步数据将以两种方式之一为未来的研究提供信息：1）如果本研究表明干预是可行的，下一项试验将评估处方扩张器使用与阴道长度之间的关联，并将进一步评估阴道长度与VBT后性功能之间的关联; 2）如果初步数据确定了可行性问题，特别是在干预依从性方面，那么本研究将为未来的试验提供替代方法，以解决方案依从性问题。虽然这个R21和随后的工作将集中在子宫内膜癌，该方法将是有用的，在继续主要研究者的研究计划，在性功能后VBT或盆腔放疗（RT）的妇科恶性肿瘤和其他恶性肿瘤，需要盆腔放疗，如直肠癌或膀胱癌。

DESCRIPTION (provided by applicant): Endometrial cancer is the most common gynecological malignancy in the United States, with 68 percent to 83 percent of women (treated with adjuvant vaginal brachytherapy (VBT) for Stage II or III) surviving 5-years. Vaginal stenosis or shortening may occur in up to 65 percent of patients treated with VBT and interfere with normal sexual function. This R21 pilot study will provide preliminary data on the feasibility of recruiting women to participate in a trial of vaginal dilator use (an instrument used to break up adhesions in the vagina after VBT) and test a method to increase compliance with the intervention. Feasibility and compliance are necessary prerequisites to future studies of the effectiveness of vaginal dilators in maintaining vaginal length post VBT and possibly sexual health. This study will also provide effect size calculations for a larger randomized trial of the use of vaginal dilators to maintain vaginal length after VBT. It is imperative to study vaginal dilatation after VBT since it is an invasive, long-term intervention that is a common recommended practice, but is based on little empirical evidence. The findings of the proposed study would provide the groundwork for future research that could have clinical implications for behavioral and device interventions to maintain sexual health after cancer therapy. The preliminary data from this study will inform future research in one of two ways: 1) if this study indicates that the intervention is feasible, the next trial will assess the association between prescribed dilator use and vaginal length and will further assess the association between vaginal length and sexual function post VBT; 2) if the preliminary data identifies feasibility problems, especially in the area of adherence to the intervention, then this study will inform a future trial of alternate methods to address protocol adherence. While this R21 and the subsequent work will focus on endometrial cancer, the methodology will be useful in continuing the principal investigator's program of research in sexual function after VBT or pelvic radiotherapy (RT) for both gynecologic malignancies and other malignancies that require pelvic RT such as rectal or bladder cancer.