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: 7706328
• 负责人: Deborah Watkins Bruner
• 金额: $ 18.83万
• 依托单位: UNIVERSITY OF PENNSYLVANIA
• 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 2011-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7706328
• 关键词: Address; Adherence; Adhesions; Adjuvant; Affect; Aftercare; Area; Behavioral; Brachytherapy; Cancer Control; Cancer Survivorship; Clinical; Clinical Trials; Data; Devices; Dilatation - action; Dilator; Disease; Dose; Effectiveness; Endometrial; Endometrial Carcinoma; Erectile dysfunction; Feasibility Studies; Functional disorder; Future; Gender; Gynecologic; Health behavior; Instruction; Intervention; Knowledge; Legal patent; Length; Life; Literature; Maintenance; Malignant Neoplasms; Malignant neoplasm of cervix uteri; Malignant neoplasm of urinary bladder; Measurement; Measures; Methodology; Methods; NIH Program Announcements; Obesity; Patients; Pelvis; Pilot Projects; Prevalence; Prevention; Principal Investigator; Procedures; Prostate Cancer therapy; Protocols documentation; Publications; Radiation therapy; Randomized; Randomized Controlled Clinical Trials; Recruitment Activity; Reporting; Research; Rest; Risk Factors; Sex Behavior; Sex Functioning; Sexual Dysfunction; Sexual Health; Staging; Stenosis; Suggestion; Telephone; Testing; Time; United States; Upper arm; Vagina; Woman; Work; base; cancer therapy; design; follow-up; instrument; neglect; non-compliance; prevent; programs; public health relevance; rectal; satisfaction

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. PUBLIC HEALTH RELEVANCE: 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, both of which are necessary prerequisites to future studies of the effectiveness of vaginal dilators in maintaining vaginal length and helping maintain sexual health after VBT.

描述(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(接受辅助阴道近距离放射治疗(VBT)进行II或III期治疗)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(一种用于在VBT后分解阴道粘连的工具)试验的可行性的初步数据，并测试一种提高干预依从性的方法。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有效性的必要前提。这项研究还将为VBT后使用阴道扩张器维持阴道长度的更大规模的随机试验提供效果大小的计算。研究VBT后的阴道扩张是非常必要的，因为这是一种侵入性的、长期的干预措施，这是一种常见的推荐做法，但基于的经验证据很少。这项拟议的研究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。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，下一次试验将评估处方扩张器的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后的性功能之间的关联；2)如果初步数据发现可行性问题，特别是在干预的依从性方面，那么这项研究将为未来的替代方法试验提供信息，以解决方案的遵守问题。虽然这项R21和随后的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VBT或盆腔放射治疗(RT)后的性功能研究计划，用于妇科恶性肿瘤和其他需要盆腔放射治疗的恶性肿瘤，如直肠癌或膀胱癌。公共卫生相关性：子宫内膜癌是美国最常见的妇科恶性肿瘤，68%至83%的女性(接受辅助阴道近距离放射治疗(VBT)进行II或III期治疗)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试点研究将提供有关招募女性参与阴道扩张器(一种用于打破VBT后阴道粘连的工具)试验的初步数据，并测试一种提高干预依从性的方法，这两项都是未来研究VBT后阴道扩张器在维持阴道长度和帮助维持性健康方面有效性的必要前提。