Effect of Sleep Quality on Hematopoietic Cell Transplant Patient Outcomes

Medical College of Wisconsin

Status: Terminated

Conditions: Multiple Myeloma; Sleep

Treatments: Behavioral: Mindfulness Awareness Practices for Insomnia; Behavioral: Sleep Health Information

Study type: Interventional

Funder types: Other

Identifiers

NCT04271930

PRO00036928

Details and patient eligibility

About

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.

Full 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.

Enrollment: 24 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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of any study related procedure not part of standard medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care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)

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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24 participants in 2 patient groups

Mindfulness Awareness Practices for Insomnia

Experimental group

Description:

Participants will be instructed to practice mindfulness techniques on a daily basis, beginning with 5 minutes and increasing to 20 minutes over the course of the 6-week intervention - as is standard with the Mindfulness Awareness Practices (MAPs) course - with practice prior to bedtime. An intervention training manual is the cornerstone of standardized delivery of MAP-I. Participants are also provided with a book on mindfulness (Fully Present: The Science, Art, and Practice of Mindfulness, authored by the Mindfulness Awareness Research Center (MARC) leader and MAP-I instructor Diana Winston) as well as access to the University of California Los Angeles (UCLA) Mindful App courtesy of the MARC at UCLA (via personal iPhone or study-administered tablets per patient preference), which contains pre-recorded guided meditations for use in daily practice.

Treatment:

Behavioral: Mindfulness Awareness Practices for Insomnia

Sleep Health Education

Active Comparator group

Description:

Six individual 1-hour videos will be shown to participants at the same time points as, and with equal duration to, the MAP-I intervention. These videos will be recorded presentations that have been modified for HCT recipients based upon similar SHE interventions delivered in prior studies. Similar to the intervention group, patients in the SHE group will also participate in group Zoom chat sessions with equal frequency and duration lead by a study research coordinator. These sessions will allow for general patient interaction to discuss sleep and any questions or comments they may have, as lead by the group facilitator.

Treatment:

Behavioral: Sleep Health Information