A Novel Digital Application (SHIFT) to Improve Outcomes for Hematopoietic Stem Cell Transplant Survivors
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMassachusetts General Hospital
About this trial
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 criteria
Qualifiers
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
Disqualifiers
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.
Trial design
Treatments tested in this trial
- SHIFT Intervention Group
- Enhanced Usual Care Group
Treatment groups
300 Participants
are divided into 2 treatment groupsLocations
3University of Miami33124, Coral GablesFlorida, United States
Massachusetts General Hospital (MGH)02114, BostonMassachusetts, United States
Fox Chase Cancer Center19111, PhiladelphiaPennsylvania, United States
Sponsors and collaborators
Massachusetts General Hospital
Lead sponsor
National Cancer Institute (NCI)
Collaborator
Source ClinicalTrials.gov