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Effect of Sleep Quality on Hematopoietic Cell Transplant Patient Outcomes

Primary Purpose

Sleep, Multiple Myeloma

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Mindfulness Awareness Practices for Insomnia
Sleep Health Information
Sponsored by
Medical College of Wisconsin
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Sleep focused on measuring Sleep, Insomnia, Mindfulness Awareness Practices for Insomnia, Sleep Health Education, Multiple Myeloma, Autologous Hematopoietic Cell Transplantation, Depression, Inflammation, Sleep hygiene, Fatigue

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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of any study related procedure not part of standard medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care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)

Sites / Locations

  • Froedtert Hospital and the Medical College of WisconsinRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Mindfulness Awareness Practices for Insomnia

Sleep Health Education

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Full Information

First Posted
February 14, 2020
Last Updated
September 7, 2023
Sponsor
Medical College of Wisconsin
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1. Study Identification

Unique Protocol Identification Number
NCT04271930
Brief Title
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

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 1, 2020 (Actual)
Primary Completion Date
September 2024 (Anticipated)
Study Completion Date
March 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical College of Wisconsin

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
7 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Mindfulness Awareness Practices for Insomnia
Arm Type
Experimental
Arm Description
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.
Arm Title
Sleep Health Education
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Mindfulness Awareness Practices for Insomnia
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Sleep Health Information
Intervention Description
A video SHE seminar will serve as active comparator for nonspecific treatment elements that pose rival explanations for the effectiveness of MAP-I.
Primary Outcome Measure Information:
Title
Number of Participants Enrolling in the Study
Description
This outcome measure is the number of participants signed consent and were enrolled compared to the number of potential participants assessed for eligibility.
Time Frame
Up to 2 weeks
Title
Number of Participants Completing Study Procedures
Description
This outcome measure is the number of participants completing the required study procedures compared to the number of participants initiating study procedures.
Time Frame
100 days after transplant procedure

10. Eligibility

Sex
All
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Cancer Center Clinical Trials Office
Phone
866-680-0505
Ext
8900
Email
cccto@mcw.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Jennifer Knight, MD
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jennifer Knight, MD
Organizational Affiliation
Medical College of Wisconsin
Official's Role
Principal Investigator
Facility Information:
Facility Name
Froedtert Hospital and the Medical College of Wisconsin
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cancer Center Clinical Trials Office
Phone
866-680-0505
Ext
8900
Email
cccto@mcw.edu

12. IPD Sharing Statement

Plan to Share IPD
No

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Effect of Sleep Quality on Hematopoietic Cell Transplant Patient Outcomes

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