A Digital Intervention to Address Sexual Health in Hematopoietic Stem Cell Transplant Survivors

Background: Interventions to address sexual health in hematopoietic stem cell transplant (HSCT) survivors are limited. Methods: We conducted a pilot randomized trial of a digital app, SHIFT (Sexual Health and Intimacy Following Transplant), to address sexual dysfunction in HSCT survivors who were ≥3 months post autologous or allogeneic HSCT. Patients were randomly assigned to SHIFT or enhanced usual care. All participants first underwent a brief physical examination by a trained HSCT clinician. Participants assigned to the intervention received access to SHIFT for 8 weeks. SHIFT consists of 5 modules addressing the biological, interpersonal, social, and psychological causes of sexual dysfunction. The primary endpoint was feasibility, defined a priori as ≥60% enrollment of eligible patients, and 60% of those assigned to SHIFT completing ≥70% of the modules. We assessed patient satisfaction with sex, interest in sex, orgasm pleasure (using the Patient-Reported Outcomes Measurement Information System [PROMIS]), quality of life (QoL; using the Functional Assessment of Cancer Therapy – Bone Marrow Transplant [FACT-BMT]), and anxiety and depression symptoms (using the Hospital Anxiety and Depression Scale [HADS]) at baseline, 8 weeks, and 12 weeks. The preliminary effects of SHIFT on study outcomes were explored using analysis of covariance (ANCOVA) and estimates of effect size at 8 weeks (Cohen’s d). Results: We enrolled 64.2% (61/95) of eligible patients. Of those assigned to the intervention, 70.0% completed 4 of the 5 SHIFT modules and 66.7% completed all SHIFT modules. At 8 weeks, SHIFT participants reported improved satisfaction with sex (14.6 vs 12.3; d=0.46), interest in sex (6.7 vs 5.7; d=0.59), orgasm pleasure (9.7 vs 8.3; d=0.37), QoL (115.6 vs 108.3; d=0.45), and symptoms of anxiety (4.5 vs 6.4; d=0.47) and depression (3.6 vs 5.4; d=0.62) compared with the control group. Conclusions: The SHIFT digital app to address sexual dysfunction demonstrated feasibility and promising preliminary efficacy in improving sexual health outcomes, QoL, and psychological distress for HSCT survivors.