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.
