Multimodal Mobile Intervention Application (app) to Address Symptoms in Hematopoietic Stem Cell Transplant Survivors

项目摘要/摘要 概述：这项研究的目标是开发、提炼和测试自我评估的可行性和初步有效性 移动式性功能障碍干预应用(APP)改善造血结局的临床研究 干细胞移植(HCT)幸存者。 背景：性功能障碍是HCT后最常见的并发症，超过40%的男性和60%的男性 报告移植后长期性功能障碍的女性幸存者。重要的是，性功能障碍 与较差的生活质量(QOL)、关系不满足感和心理困扰有关，这进一步 导致了这一人群的发病率。HCT幸存者经历了独特而广泛的生物， 影响他们性功能的人际、心理和社会因素。考虑到多因素的性质 对于性功能障碍，多模式方法是必要的，以解决患者的具体问题和关切。 尽管在这个通常年轻的患者群体中，HCT的使用越来越多，性功能障碍的负担也很重， 目前还没有针对他们性功能障碍的干预措施。我们完成了一项初步研究，在这项研究中我们 招募患有性功能障碍的HCT幸存者参加一项多模式干预， 需要每月访问训练有素的学习护士实践者。我们证明了干预是可行的。 并在统计和临床上显著改善了患者对性行为的满意度和兴趣，性行为 健康和功能，生活质量，以及抑郁和焦虑的症状。尽管我们之前的工作取得了成功，但 大多数HCT幸存者将无法接触到拥有专业知识的临床医生来解决他们的性功能障碍。 研究计划：我们建议将我们的性健康干预改编为一款移动应用程序，患者可以在该应用程序上自我 通过平板电脑进行管理，以确保干预的可及性和可扩展性。我们最近获得了 用于开发多模式移动应用程序的资金，以解决HCT幸存者的性功能障碍问题。建议的R21 项目将使用定性和定量相结合的方法来1)基于开放的试点研究提炼应用程序 6名经历了性功能障碍的HCT幸存者和2)进行了一项试点随机对照试验 APP与增强型标准护理在80例HCT幸存者中的比较 手机应用程序改善患者报告的性功能、生活质量和情绪。 环境：该项目将在马萨诸塞州总医院(MGH)癌症中心进行， 该中心照顾1000多名HCT幸存者，每年进行200多例移植。埃尔-贾瓦赫里博士将合作- 在支持性和姑息治疗研究方面与国家公认的研究团队合作，行为 干预发展、工程学和性健康。 研究的相关性：该项目将测试一个创新的、以患者为中心的移动应用程序，它将在很大程度上 加强对HCT幸存者的护理，具有易于传播和广泛使用的潜力。

PROJECT SUMMARY/ABSTRACT Overview: The goal of this study is to develop, refine, and test the feasibility and preliminary efficacy of a self- administered, mobile sexual dysfunction intervention application (app) in improving outcomes of hematopoietic stem cell transplant (HCT) survivors. Background: Sexual dysfunction is the most common complication post-HCT with over 40% of male and 60% of female survivors reporting long-term sexual dysfunction post-transplant. Importantly, sexual dysfunction is associated with worse quality of life (QOL), relationship dissatisfaction, and psychological distress, which further contributes to the morbidity in this population. HCT survivors experience a unique and wide range of biologic, interpersonal, psychological, and social factors that impact their sexual function. Given the multifactorial nature of sexual dysfunction, a multimodal approach is necessary to address patients’ specific issues and concerns. Despite the increasing use of HCT and the burden of sexual dysfunction in this often young patient population, there are currently no interventions to address their sexual dysfunction. We completed a pilot study in which we recruited HCT survivors with sexual dysfunction causing distress to participate in a multimodal intervention that entailed monthly visits with trained study nurse practitioners. We demonstrated that the intervention was feasible and led to statistically and clinically significant improvements in patients’ satisfaction and interest in sex, sexual health and function, QOL, and symptoms of depression and anxiety. Despite the success of our prior work, the majority of HCT survivors will not have access to clinicians with expertise to address their sexual dysfunction. Research Plan: We propose to adapt our sexual health intervention to a mobile app, which patients can self- administer via tablet computer to ensure the accessibility and scalability of the intervention. We recently secured funds to develop a multimodal mobile app to address sexual dysfunction in HCT survivors. The proposed R21 project will use mixed qualitative and quantitative methods to 1) refine the app based on an open pilot study with six HCT survivors experiencing sexual dysfunction and 2) conduct a pilot randomized controlled trial of the mobile app versus enhanced standard care in 80 HCT survivors to assess the feasibility and preliminary efficacy of the mobile app in improving patient-reported sexual function, QOL, and mood. Environment: This project will be conducted at the Massachusetts General Hospital (MGH) Cancer Center, which cares for over 1000 HCT survivors and conducts over 200 transplants per year. Dr. El-Jawahri will collab- orate with a nationally recognized team of researchers in supportive and palliative care research, behavioral intervention development, engineering, and sexual health. Relevance of Research: This project will test an innovative, patient-centered, mobile app that will substantially enhance the care of HCT survivors and has the potential for easy dissemination and wide utilization.