Effect of Sleep Quality on Hematopoietic Cell Transplant Patient Outcomes

Not Applicable

Terminated

• Conditions: Sleep; Multiple Myeloma

• Registration Number: NCT04271930
• Lead Sponsor: Medical College of Wisconsin

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 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.

Study Timeline

• Study First Submitted: 2020-02-14
• Study First Submitted QC: 2020-02-14
• Study First Posted: 2020-02-17
• Study Start: 2020-11-01
• Primary Completion: 2023-05-23
• Study Completion: 2023-05-23
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-07
• Last Update Posted: 2024-10-09

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

• ≥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 Criteria

• Prior autologous HCT
• Outpatient HCT
• Presence of coexistent amyloidosis
• Presence of known Obstructive Sleep Apnea (OSA)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Number of Participants Enrolling in the Study	Up to 2 weeks	This outcome measure is the number of participants signed consent and were enrolled compared to the number of potential participants assessed for eligibility.
Number of Participants Completing Study Procedures	100 days after transplant procedure	This outcome measure is the number of participants completing the required study procedures compared to the number of participants initiating study procedures.

Trial Locations

Locations (1)

Froedtert Hospital and the Medical College of Wisconsin; 🇺🇸 Milwaukee, Wisconsin, United States