NCT04271930

Effect of Sleep Quality on Hematopoietic Cell Transplant Patient Outcomes

Mindfulness Meditation and Sleep Disturbances in Hematopoietic Cell Transplant Patients: Inflammatory Mechanisms

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Medical College of Wisconsin · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 multiple myeloma.

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) with multiple myeloma (MM) and the preliminary efficacy of Mindfulness Awareness Practices for Insomnia (MAP-I) vs. sleep health education (SHE) to improve insomnia outcomes, cellular and transcriptomic markers of inflammation, and insomnia associated behavioral symptoms (depression, fatigue). Patients enrolled in this study will be randomized to either receive MAP-I or SHE starting 2-4 weeks prior to HCT. Patients will receive two sessions prior to inpatient admission for HCT, and four sessions in the two weeks of hospitalization following HCT, for a total of six intervention (or control) sessions. Primary Objective: Determine the feasibility of implementing MAP-I among HCT recipients under first autologous HCT for MM.

Conditions

• Sleep
• Multiple Myeloma

Interventions

Type	Name	Description
BEHAVIORAL	Mindfulness Awareness Practices for Insomnia	MAP-I is a curriculum-based intervention that incorporates practice prior to bed, use of practice in the bed during night-time awakenings, and daily body scan.
BEHAVIORAL	Sleep Health Information	A video SHE seminar will serve as active comparator for nonspecific treatment elements that pose rival explanations for the effectiveness of MAP-I.

Timeline

• Start date: 2020-11-01
• Primary completion: 2023-05-23
• Completion: 2023-05-23
• First posted: 2020-02-17
• Last updated: 2024-10-09

Locations

1 site across 1 country: United States