Effect of Sleep Quality on Hematopoietic Cell Transplant Patient Outcomes

  • STATUS
    Recruiting
  • End date
    Mar 27, 2024
  • participants needed
    60
  • sponsor
    Medical College of Wisconsin
Updated on 4 October 2022
melphalan

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.

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.

Details
Condition Lymphoproliferative Disorder, Sleep, Multiple Myeloma, multiple myeloma (mm), Lymphoproliferative disorders
Treatment Mindfulness Awareness Practices for Insomnia, Sleep Health Information
Clinical Study IdentifierNCT04271930
SponsorMedical College of Wisconsin
Last Modified on4 October 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

years of age
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of any study related procedure not part of standard medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care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)
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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