Multiple Myeloma Clinical Trial

Effect of Sleep Quality on Hematopoietic Cell Transplant Patient Outcomes

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.

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Full 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.

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of any study related procedure not part of standard medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care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

Study is for people with:

Multiple Myeloma

Estimated Enrollment:

60

Study ID:

NCT04271930

Recruitment Status:

Recruiting

Sponsor:

Medical College of Wisconsin

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There is 1 Location for this study

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Froedtert Hospital and the Medical College of Wisconsin
Milwaukee Wisconsin, 53226, United States More Info
Cancer Center Clinical Trials Office
Contact
866-680-0505
[email protected]

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Study is for people with:

Multiple Myeloma

Estimated Enrollment:

60

Study ID:

NCT04271930

Recruitment Status:

Recruiting

Sponsor:


Medical College of Wisconsin

How clear is this clinincal trial information?

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