Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06590285
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-03
Brief Title:
Diagnostic Refinement and Educational Approaches in Managing Bone Marrow Transplantation
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Diagnostic Refinement and Educational Approaches in Managing Bone Marrow Transplantation DREAM-BMT
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DREAM-BMT
Brief Summary:
This randomized phase III open-label study will investigate the efficacy and safety of an educational sleep intervention vs standard of care in adults undergoing alloHSCT The randomization target in this pilot phase is 60 patients
Detailed Description:
To facilitate rapid randomization and baseline collection of patient samples in the patients home environment screening activities and assessment of inclusion and exclusion criteria will begin once the patient is identified as transplant eligible at the bone marrow transplant meeting The patient will subsequently be contacted by a study investigator to explain the study including its potential benefits and risks
Patients meeting all inclusion and exclusion criteria will be randomized 11 to receive either educational intervention or standard of care therapy
Patients meeting all inclusion and exclusion criteria will be randomized 11 to receive either educational intervention or standard of care therapy
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None