Educational Sleep and Activity Program vs Standard Care for Adults Undergoing Allogeneic Bone Marrow Transplantation

What this Trial Is About

Researchers are evaluating the effects of an educational sleep intervention compared to standard care in adults undergoing allogeneic Hematopoietic Stem Cell Transplantation alloHSCT. This phase III randomized, open-label study aims to investigate how this intervention may improve sleep and physical activity outcomes in patients facing bone marrow transplant complications such as GVHD. The trial will enroll 60 patients to assess safety and efficacy. Participants will be randomly assigned to one of two groups one receiving usual care involving alloHSCT without additional sleep-related education, and the other receiving an app-based educational program focused on sleep science, management of sleep disturbances, and physical activity tailored to alloHSCT treatment stages. The educational content includes accessible explanations of neurobiological processes and safe exercise guidance to support recovery. Throughout the study, participants will have continuous objective monitoring of sleep and physical activity from two weeks before transplant to 100 days post-transplant. Subjective sleep quality will be assessed at specific time points around the transplant. Screening and baseline sample collection start once transplant eligibility is confirmed, and the study involves remote enrollment and app-based data collection to facilitate participation in the patients home environment.

Diagnostic Refinement and Educational Approaches in Managing Bone Marrow Transplantation