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

扩张器使用的随机可行性研究和增加教育计划

• 批准号: 8367931
• 负责人: Deborah Watkins Bruner
• 金额: $ 1.93万
• 依托单位: EMORY UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2009
• 资助国家: 美国
• 起止时间: 2009-09-01 至 2013-04-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8367931
• 关键词: Randomized; Feasibility; Study; Dilator; Use

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.

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（在II期或III期接受辅助阴道近距离放射治疗（VBT））存活5年。高达65%的VBT患者可能出现阴道狭窄或缩短，并干扰正常的性功能。这项R21试点研究将为招募女性参与阴道扩张器（VBT后用于破裂阴道粘连的仪器）试验的可行性提供初步数据，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VBT后维持阴道长度和可能的性健康方面的有效性的必要先决条件。该研究还将为VBT术后使用阴道扩张器维持阴道长度的更大规模随机试验提供效应量计算。研究VBT后阴道扩张是必要的，因为它是一种侵入性的、长期的干预，是一种常见的推荐做法，但基于很少的经验证据。拟议研究的结果将为未来的研究奠定基础，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，下一个试验将评估处方扩张器使用与阴道长度之间的关系，并将进一步评估阴道长度与VBT后性功能之间的关系；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替代方法试验提供信息，以解决方案依从性问题。虽然本R21和后续工作将集中于子宫内膜癌，但该方法将有助于继续首席研究员的研究项目，即VBT或盆腔放疗（RT）后的性功能，用于妇科恶性肿瘤和其他需要盆腔放疗的恶性肿瘤，如直肠癌或膀胱癌。