Effect of Sleep Quality on Hematopoietic Cell Transplant Patient Outcomes

NCT04271930 | Terminated

• 1 other identifier: PRO00036928
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

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.

Behavioral: Mindfulness Awareness Practices for Insomnia

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.

Behavioral: Sleep Health Information

Interventions

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.

Mindfulness Awareness Practices for Insomnia

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.

Sleep Health Education

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥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

You may not qualify if:

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

Sponsors & Collaborators

• Medical College of Wisconsin: lead

Study Sites (1)

Froedtert Hospital and the Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

Related Publications (1)

• 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.

  PMID: 40893725 DERIVED

MeSH Terms

Conditions

Multiple Myeloma; Sleep Initiation and Maintenance Disorders; Depression; Inflammation; Sleep Hygiene; Fatigue

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Behavioral Symptoms; Behavior; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Health Behavior; Signs and Symptoms

Study Officials

• Jennifer Knight, MD

  Medical College of Wisconsin

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: February 14, 2020
• First Posted: February 17, 2020
• Study Start: November 1, 2020
• Primary Completion: May 23, 2023
• Study Completion: May 23, 2023
• Last Updated: October 9, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)