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，其中68％至83％的妇女（用辅助性阴道近距离治疗（VBT）用于II期或III期）5年。在接受VBT治疗的患者中，可能会发生阴道狭窄或缩短，并干扰正常的性功能。这项R21试点研究将提供有关招募妇女参与阴道扩张剂使用试验的可行性的初步数据（一种用于打破VBT后阴道中粘附的仪器）并测试一种增加对干预措施依从性的方法。可行性和依从性是对未来对阴道扩张剂在维持VBT和可能性健康的阴道长度有效性的研究的必要先决条件。这项研究还将提供效果尺寸计算，以进行更大的随机试验，即使用阴道扩张器在VBT后保持阴道长度。必须研究VBT后的阴道扩张，因为它是一种侵入性的长期干预措施，是一种常见的建议做法，但基于几乎没有经验证据。拟议研究的发现将为未来的研究提供基础，该研究可能对行为和装置干预措施具有临床意义，以维持癌症治疗后的性健康。这项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）如果这项研究表明干预是可行的，则下一个试验将评估规定的扩张器使用与阴道长度之间的关联，并将进一步评估VBT后阴道长度与性功能之间的关联； 2）如果初步数据确定了可行性问题，尤其是在遵守干预措施的领域，那么本研究将为未来的替代方法试验，以解决协议依从性。尽管这项R21和随后的工作将重点放在子宫内膜癌上，但该方法将有助于在VBT或VBT或骨盆放射治疗（RT）的性功能研究计划（RT）方面对妇科恶性肿瘤和其他需要骨盆rt等骨盆癌等恶性肿瘤，例如直肠或玻璃直肠癌。