Title: Multi-Site Randomized Controlled Trial of a Novel Digital Application (SHIFT) to Improve Outcomes for Hematopoietic Stem Cell Transplant Survivors

PROJECT SUMMARY/ABSTRACT Overview: The goal of this study is to examine the efficacy of a novel digital application (SHIFT) for improving sexual health outcomes, quality of life (QOL), and psychological outcomes in hematopoietic stem cell transplant (HCT) survivors. Background: Sexual dysfunction is the most common and persistent complication post-HCT, with over 50% of

male and 60-80% of female HCT survivors reporting long-term impairment in sexual function post-HCT. Impair- ment in sexual function is associated with worse 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 multifac- torial nature of sexual dysfunction, a multimodal approach is necessary to address patients’ specific issues and concerns. Despite the increasing use of HCT and the prevalence of sexual dysfunction in HCT survivors, inter-

ventions to improve sexual health outcomes are lacking. Limited availability of clinicians with expertise in ad- dressing sexual health concerns at most transplant centers hinders the scalability and dissemination of in-person supportive care interventions to address sexual health concerns. We developed a self-administered novel digital

app (SHIFT) for HCT survivors experiencing sexual health concerns. SHIFT includes five modules focused on empowering patients to address their sexual health concerns with attention to the biologic, interpersonal, psy- chological, and social factors contributing to sexual dysfunction. We recently completed a pilot randomized trial

demonstrating the feasibility of SHIFT and its promising efficacy for improving sexual health outcomes (i.e., sexual satisfaction, interest, and function), as well as QOL, and psychological distress compared to enhanced usual care. Research Plan: We propose to conduct a multi-site randomized trial of SHIFT versus enhanced usual care in

300 HCT survivors to assess the efficacy of SHIFT for improving patient-reported sexual health outcomes. We will also assess the impact of SHIFT on patients’ QOL and psychological outcomes as well as explore mediators and moderators of the intervention effect on patient-reported QOL. Environment: This project will be conducted at Massachusetts General Hospital, Fox Chase, and the University

of Miami. These sites have the supportive care research and transplant experience, infrastructure, and pro- cesses to conduct this trial. The MGH research team has the expertise in developing and testing supportive care and digital health interventions for patients with serious illness and HCT survivors to ensure the successful im-

plementation of this trial across all study sites. Relevance of Research: Data from this project will be used to obtain FDA approval for SHIFT as a digital therapeutic that can be prescribed to address the sexual health needs of HCT survivors.