Effect of Sleep Quality on Hematopoietic Cell Transplant Patient Outcomes

N/ATerminatedNCT04271930

Medical College of Wisconsin24 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

Conditions

Sleep Multiple Myeloma

Interventions

Mindfulness Awareness Practices for InsomniaBEHAVIORAL

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.

Sleep Health InformationBEHAVIORAL

A video SHE seminar will serve as active comparator for nonspecific treatment elements that pose rival explanations for the effectiveness of MAP-I.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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)

Locations (1)

Froedtert Hospital and the Medical College of Wisconsin

Milwaukee, Wisconsin, United States

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: 100 days after transplant procedure

Data from ClinicalTrials.gov

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