Status:
TERMINATED
Effect of Sleep Quality on Hematopoietic Cell Transplant Patient Outcomes
Lead Sponsor:
Medical College of Wisconsin
Conditions:
Sleep
Multiple Myeloma
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This randomized, controlled study will compare Mindfulness Awareness Practices for Insomnia (MAP-I) to sleep health education (SHE) in subjects receiving autologous hematopoietic cell transplant for m...
Detailed Description
This randomized controlled study will evaluate the feasibility of implementing a mindfulness intervention targeting inpatient autologous hematopoietic cell transplantation (HCT) recipients (first HCT)...
Eligibility Criteria
Inclusion
- ≥18 years of age
- ≤ 1 year since initiation of systemic anti-myeloma therapy
- No prior progression or relapse of myeloma prior to HCT
- Patient should be eligible to receive melphalan 200 mg/m2 as conditioning regimen
- Stem cell graft with \> 2.0 x10\^6 cluster of differentiation 34 cells (CD34+)/kg available for transplant
- Karnofsky Performance Score (KPS) ≥70
- Agreeable to random assignment and data collection, including survey completion and blood draws
- Available to attend the outpatient intervention portion.
- Voluntary written consent must be given before performance of any study related procedure not part of standard medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care
Exclusion
- Prior autologous HCT
- Outpatient HCT
- Presence of coexistent amyloidosis
- Presence of known Obstructive Sleep Apnea (OSA)
Key Trial Info
Start Date :
November 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 23 2023
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT04271930
Start Date
November 1 2020
End Date
May 23 2023
Last Update
October 9 2024
Active Locations (1)
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1
Froedtert Hospital and the Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226