A multimodal sexual dysfunction intervention versus enhanced usual care for survivors of haematopoietic stem-cell transplantation: a single-centre, open-label, randomised clinical trial.

BACKGROUND Sexual dysfunction is a common complication affecting survivors of haematopoietic stem-cell transplantation (HSCT). Interventions to address sexual health in survivors of HSCT are limited. We aimed to assess the efficacy of a multimodal sexual dysfunction intervention for improving sexual health, quality of life (QOL), and psychological outcomes in survivors of HSCT. METHODS We conducted a single-centre, open-label, randomised clinical trial of a multimodal intervention to address sexual dysfunction in survivors of HSCT at Massachusetts General Hospital. Participants were aged 18 years or older, had a haematological malignancy, and had undergone autologous or allogeneic HSCT at least 3 months before study enrolment, with a positive screening for sexual dysfunction causing distress according to the National Comprehensive Cancer Network survival guidelines. Patients were randomly assigned to the intervention (participants met with a trained HSCT clinician for an initial 60 mins visit, followed by two 30-45 mins monthly visits, either in person, by telephone, or over a secure video platform) or enhanced usual care (EUC) using computer-generated block randomisation, stratified by transplantation type and sex. The primary endpoint was to compare global satisfaction with sex scores (PROMIS sexual function and satisfaction measure) at 3 months between the study groups. We conducted analyses in accordance with the intention-to-treat principle. This study was registered with ClinicalTrials.gov (NCT03803696) and is complete. FINDINGS Between Feb 15, 2019 and Feb 3, 2023, 125 (74%) of 169 eligible patients were enrolled to the study. Enrolled patients were mostly White (107 [86%] of 125), non-Hispanic (113 [90%]), and male (84 [67%]), and had a median age of 57·8 years (IQR 46·5-65·8, range 20·3-81·9). 91 (73%) had received an allogeneic HSCT. At 3 months, patients randomised to the intervention reported better global satisfaction with sex (11·5 [SD 5·1] at baseline to 15·8 [SD 5·3] at 3 months) compared to EUC (from 11·1 [4·5] to 11·2 [SD 5·1]; mean difference 4·7 [95% CI 3·0-6·3], Cohen's d=0·85, p<0·0001). INTERPRETATION A multimodal intervention delivered by trained HSCT clinicians resulted in improvements in global satisfaction with sex. These findings underscore the potential of this intervention to be integrated into routine transplant care to improve sexual health outcomes for HSCT survivors. FUNDING American Cancer Society and the Leukemia & Lymphoma Society.