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This study terminated early due to lack of participant retention
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mindfulness Awareness Practices for Insomnia | Experimental | 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. |
|
| Sleep Health Education | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mindfulness Awareness Practices for Insomnia | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Enrolling in the Study | This outcome measure is the number of participants signed consent and were enrolled compared to the number of potential participants assessed for eligibility. | Up to 2 weeks |
| Number of Participants Completing Study Procedures | This outcome measure is the number of participants completing the required study procedures compared to the number of participants initiating study procedures. | 100 days after transplant procedure |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jennifer Knight, MD | Medical College of Wisconsin | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Froedtert Hospital and the Medical College of Wisconsin | Milwaukee | Wisconsin | 53226 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40893725 | Derived | Henley EC, Liphart HA, Morris KJ, Awoyinka I, Irwin MR, Costanzo ES, Winston D, D'Souza A, Stolley M, Dhakal B, Mohan M, Pasquini MC, Cole SW, Doerwald ES, Bendis PC, Rentscher KE, Rumble ME, Szabo A, Rao S, Knight JM. Mindfulness vs. sleep education during autologous hematopoietic cell transplantation for multiple myeloma: Feasibility of a randomized controlled pilot study. Contemp Clin Trials Commun. 2025 Aug 18;47:101540. doi: 10.1016/j.conctc.2025.101540. eCollection 2025 Oct. |
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| ID | Term |
|---|---|
| D009101 | Multiple Myeloma |
| D007319 | Sleep Initiation and Maintenance Disorders |
| D003863 | Depression |
| D007249 | Inflammation |
| D000070263 | Sleep Hygiene |
| D005221 | Fatigue |
| ID | Term |
|---|---|
| D054219 | Neoplasms, Plasma Cell |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D020141 | Hemostatic Disorders |
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| Sleep Health Information | Behavioral | A video SHE seminar will serve as active comparator for nonspecific treatment elements that pose rival explanations for the effectiveness of MAP-I. |
|
| D014652 |
| Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006474 | Hemorrhagic Disorders |
| D008232 | Lymphoproliferative Disorders |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D001523 | Mental Disorders |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D015438 | Health Behavior |
| D012816 | Signs and Symptoms |