A Novel Digital Application (SHIFT) to Improve Outcomes for Hematopoietic Stem Cell Transplant Survivors
Multi-Site Randomized Controlled Trial of a Novel Digital Application (SHIFT) to Improve Outcomes for Hematopoietic Stem Cell Transplant Survivors
Massachusetts General Hospital
300 participants
Jan 27, 2025
INTERVENTIONAL
Conditions
Summary
This research study is evaluating the efficacy of a novel self-administered digital application for improving sexual health outcomes, quality of life, and psychological distress in hematopoietic stem cell transplant survivors.
Eligibility
Inclusion Criteria2
- Adult patients (\> 18 years) who underwent autologous or allogeneic HCT \> three months prior to study enrollment
- Screen positive for sexual health concerns causing distress based on the National Comprehensive Network (NCCN) survivorship guidelines screening questions
Exclusion Criteria3
- Patients who do not comprehend English or Spanish since SHIFT will only be available in these two languages for this efficacy trial.
- Patients with any major uncontrolled psychiatric disorder or other comorbid cognitive conditions, which the treating HCT clinician believes would prohibit the patients' capacity to provide informed consent and participate in study procedures.
- Patients with relapsed disease requiring treatment.
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
Participants assigned to SHIFT will meet with their HCT clinician for a brief medical examination to assess the need for medications for erectile dysfunction, vaginal atrophy, or genital graft-versus-host disease; and start using SHIFT at their desired pace over 8 weeks to complete five modules.
Participants assigned to the enhanced usual care group will meet with their HCT clinician for a brief medical examination to assess the need for medications for erectile dysfunction, vaginal atrophy, or genital graft-versus-host disease; and maybe referred to a psychologist, urologist, or gynecologist at the participants' request or at the discretion of the HCT clinician.
Locations(3)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06541002