Effect of Sleep Quality on Hematopoietic Cell Transplant Patient Outcomes

NCT ID: NCT04271930

Last Updated: 2024-10-09

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-11-01
• Study Completion Date: 2023-05-23

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.

Conditions

Sleep; Multiple Myeloma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Mindfulness Awareness Practices for Insomnia

Intervention Type: BEHAVIORAL

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 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.

Group Type: ACTIVE_COMPARATOR

Sleep Health Information

Intervention Type: BEHAVIORAL

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

Interventions

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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medical College of Wisconsin

OTHER

Sponsor Role: lead

Responsible Party

Jennifer M. Knight

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jennifer Knight, MD

Role: PRINCIPAL_INVESTIGATOR

Medical College of Wisconsin

Locations

Froedtert Hospital and the Medical College of Wisconsin

Milwaukee, Wisconsin, United States

Countries

United States

References

Henley EC, Liphart HA, Morris KJ, Awoyinka I, Irwin MR, Costanzo ES, Winston D, D'Souza A, Stolley M, Dhakal B, Mohan M, Pasquini MC, Cole SW, Doerwald ES, Bendis PC, Rentscher KE, Rumble ME, Szabo A, Rao S, Knight JM. Mindfulness vs. sleep education during autologous hematopoietic cell transplantation for multiple myeloma: Feasibility of a randomized controlled pilot study. Contemp Clin Trials Commun. 2025 Aug 18;47:101540. doi: 10.1016/j.conctc.2025.101540. eCollection 2025 Oct.

Reference Type: DERIVED

PMID: 40893725 (View on PubMed)

Other Identifiers

PRO00036928

Identifier Type: -

Identifier Source: org_study_id