Clinical trial NCT04271930: Effect of Sleep Quality on Hematopoietic Cell Transplant Patient Outcomes
Official title: Mindfulness Meditation and Sleep Disturbances in Hematopoietic Cell Transplant Patients: Inflammatory Mechanisms
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Sleep
Multiple Myeloma
Keywords: Sleep
Insomnia
Mindfulness Awareness Practices for Insomnia
Sleep Health Education
Multiple Myeloma
Autologous Hematopoietic Cell Transplantation
Depression
Inflammation
Sleep hygiene
Fatigue
Lead sponsor: Medical College of Wisconsin
Sponsor class: OTHER
First posted: 2020-02-17
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Number of Participants Enrolling in the Study
timeFrame: Up to 2 weeks
measure: Number of Participants Completing Study Procedures
timeFrame: 100 days after transplant procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Milwaukee
country: United States
facility: Froedtert Hospital and the Medical College of Wisconsin
state: Wisconsin
Study officials:
affiliation: Medical College of Wisconsin
name: Jennifer Knight, MD
role: PRINCIPAL_INVESTIGATOR
References: