Multiple Myeloma, Sleep
Conditions
Keywords
Sleep, Insomnia, Mindfulness Awareness Practices for Insomnia, Sleep Health Education, Multiple Myeloma, Autologous Hematopoietic Cell Transplantation, Depression, Inflammation, Sleep hygiene, Fatigue
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.
Interventions
BEHAVIORALMindfulness 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.
BEHAVIORALSleep 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.
Sponsors
Medical College of Wisconsin
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Outcome results
None listed