Multimodal Mobile Application to Address Sexual Dysfunction in Hematopoietic Stem Cell Transplant (HCT) Survivors

Abstract

Background: Sexual dysfunction is the most common complication affecting HCT survivors and is associated with worse patient-reported quality of life (QOL) and psychological distress. Yet, interventions to address sexual dysfunction in HCT survivors are lacking. Methods: We conducted a pilot randomized trial of a multimodal mobile application (SHIFT) to address sexual dysfunction for patients with hematologic malignancies who were at least 3 months post autologous or allogeneic HCT and endorsed sexual dysfunction causing distress. Patients were randomly assigned to SHIFT or enhanced usual care. Intervention participants met with a trained HCT clinician for a brief clinical exam to address biological causes of sexual dysfunction and were then provided access to SHIFT for 8 weeks. SHIFT consists of five modules focused on educating and empowering patients to address their sexual health concerns and addressing the biologic, interpersonal, social, and psychological causes of sexual dysfunction. Patients assigned to enhanced usual care met with the trained HCT clinician for a brief clinical exam and they were not given access to SHIFT. The primary endpoint was feasibility, defined a priori as at least 60% of eligible patients enrolling and 60% of those enrolled completing at least 70% of the SHIFT modules. We assessed patient global satisfaction with sex, interest in sex, orgasm pleasure (PROMIS), QOL (Functional Assessment of Cancer Therapy-Bone Marrow Transplant [FACT-BMT]), and psychological distress (Hospital Anxiety and Depression-Scale [HADS]) at baseline and 8 weeks. To assess the usability of SHIFT, we used the System Usability Scale (>80 indicates excellent usability). We a priori identified a p-value <0.25 as promising for preliminary efficacy in this pilot study. Results: We enrolled 64.2% (61/95) of eligible patients (mean age = 57.2 (SD=14.2), 60% male). In the intervention group, 70.0% completed ≥ 80% of the SHIFT modules, and 66.7% completed all SHIFT modules. Patients assigned to SHIFT used the app for a mean of 155 minutes (Range: 38.1 - 394.9). At 8 weeks, patients randomized to SHIFT reported improved satisfaction with sex (14.6 vs. 12.3, P=0.076), interest in sex (6.7 vs. 5.7, P=0.040), and orgasm pleasure (9.7 vs. 8.2, P=0.106), compared to those assigned to enhanced usual care. SHIFT participants also reported better QOL (115.6 vs. 108.3, P=0.039), anxiety (4.6 vs. 6.4, P=0.043), and depression symptoms (3.6 vs. 5.4, P=0.016) compared to those assigned to enhanced usual care. The SHIFT mean usability score was 80.5 (SD=13.6). Conclusions: A multimodal mobile app to address sexual dysfunction is feasible to use for HCT survivors and has promising preliminary efficacy for improving sexual health outcomes, QOL, and psychological distress. A future multi-site trial is needed to assess the efficacy of SHIFT for improving sexual function and QOL in HCT survivors.