Effect of Sleep Quality on Hematopoietic Cell Transplant Patient Outcomes

Mindfulness Meditation and Sleep Disturbances in Hematopoietic Cell Transplant Patients: Inflammatory Mechanisms

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.

Study Overview

• Status: Recruiting
• Conditions: Multiple Myeloma; Sleep
• Intervention / Treatment: Behavioral: Mindfulness Awareness Practices for Insomnia; Behavioral: Sleep Health Information

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.

• Study Type: Interventional
• Enrollment (Estimated): 7
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jennifer Knight, MD
• Study Contact Backup: Name: Cancer Center Clinical Trials Office; Phone Number: 8900 866-680-0505; Email: cccto@mcw.edu

Study Locations

• United States
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53226
      • Recruiting
      • Froedtert Hospital and the Medical College of Wisconsin
      • Contact: Cancer Center Clinical Trials Office; Phone Number: 8900 866-680-0505; Email: cccto@mcw.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Mindfulness Awareness Practices for Insomnia; 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; 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.
Active Comparator: Sleep Health Education; 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; A video SHE seminar will serve as active comparator for nonspecific treatment elements that pose rival explanations for the effectiveness of MAP-I.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Medical College of Wisconsin
• Investigators: Principal Investigator: Jennifer Knight, MD, Medical College of Wisconsin

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2020
• Primary Completion (Estimated): September 1, 2024
• Study Completion (Estimated): March 1, 2025

Study Registration Dates

• First Submitted: February 14, 2020
• First Submitted That Met QC Criteria: February 14, 2020
• First Posted (Actual): February 17, 2020

Study Record Updates

• Last Update Posted (Actual): September 11, 2023
• Last Update Submitted That Met QC Criteria: September 7, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: Depression; Inflammation; Multiple Myeloma; Fatigue; Sleep; Insomnia; Sleep hygiene; Autologous Hematopoietic Cell Transplantation; Mindfulness Awareness Practices for Insomnia; Sleep Health Education
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Immunoproliferative Disorders; Hematologic Diseases; Hemorrhagic Disorders; Hemostatic Disorders; Paraproteinemias; Blood Protein Disorders; Neoplasms, Plasma Cell; Multiple Myeloma
• Other Study ID Numbers: PRO00036928

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No