Trials Sponsors Conditions Drugs Pricing

Conditions

Keywords

SleepInsomniaMindfulness Awareness Practices for InsomniaSleep Health EducationMultiple MyelomaAutologous Hematopoietic Cell TransplantationDepressionInflammationSleep hygieneFatigue

Outcome Measures

Primary Outcomes (2)

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.
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.
100 days after transplant procedure

Study Arms (2)

Mindfulness Awareness Practices for Insomnia

EXPERIMENTAL

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.

Behavioral: Mindfulness Awareness Practices for Insomnia

Sleep Health Education

ACTIVE COMPARATOR

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.

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.

Mindfulness Awareness Practices for Insomnia

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 Criteria

Age18 Years+

Sexall(Gender-based eligibility)

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

≥18 years of age
≤ 1 year since initiation of systemic anti-myeloma therapy

Sponsors & Collaborators

Medical College of Wisconsin
Otherlead

Study Sites (1)

Froedtert Hospital and the Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Related Publications (1)

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.
PMID: 40893725DERIVED

MeSH Terms

Conditions

Multiple MyelomaSleep Initiation and Maintenance DisordersDepressionInflammationSleep HygieneFatigue

Condition Hierarchy (Ancestors)

Neoplasms, Plasma CellNeoplasms by Histologic TypeNeoplasmsHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHematologic Diseases

Study Officials

Jennifer Knight, MD
Medical College of Wisconsin
PRINCIPAL INVESTIGATOR

Enrollment

24 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: not applicable
Allocation: RANDOMIZED
Masking: NONE
Purpose: SUPPORTIVE CARE
Intervention Model: PARALLEL
Sponsor Type: OTHER
Responsible Party: PRINCIPAL INVESTIGATOR
PI Title: Assistant Professor

Study Record Dates

First Submitted

February 14, 2020

First Posted

February 17, 2020

Study Start

November 1, 2020

Actual (reported)

Study Stopped

Effect of Sleep Quality on Hematopoietic Cell Transplant Patient Outcomes

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (2)

Study Arms (2)

Mindfulness Awareness Practices for Insomnia

Sleep Health Education

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Publications (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (2)

Study Arms (2)

Mindfulness Awareness Practices for Insomnia

Sleep Health Education

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Publications (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations