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

What this Trial Is About

This research investigates a new self-administered digital application designed to improve sexual health, quality of life, and psychological distress among survivors of hematopoietic stem cell transplants (HCT). HCT survivors often face long-term sexual dysfunction due to complex biological, psychological, and social factors, which significantly affect their well-being and relationships. The study aims to address these challenges through a multidisciplinary approach delivered via a digital platform. Participants will be randomly assigned to either use the SHIFT digital application or receive enhanced usual care. The SHIFT app includes interactive features like gamification, survivor videos, intimacy exercises, and optional content to engage users over eight weeks. Those in the usual care group will meet with their clinicians and may be referred to specialists if needed but will not have access to the SHIFT app. During the study, participants will complete assessments measuring sexual satisfaction, function, quality of life, anxiety, and depression at various points up to 24 weeks. Researchers will monitor global satisfaction with sex at week 8 as the primary outcome. The study involves medical evaluations and tracks psychological and physical health through questionnaires and scales, aiming to evaluate the impact of the digital intervention on sexual health outcomes and overall well-being in HCT survivors.

A Novel Digital Application (SHIFT) to Improve Outcomes for Hematopoietic Stem Cell Transplant Survivors