Mindfulness for Insomnia in Multiple Myeloma Patients

Overseen by Jennifer Knight, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Medical College of Wisconsin

No Placebo Group

Trial Summary

What is the purpose of this trial?

This trial will test if mindfulness exercises can help patients with multiple myeloma who are getting a specific type of cell transplant to sleep better. The study will compare these exercises to regular sleep health education.

Research Team

Jennifer Knight, MD

Principal Investigator

Medical College of Wisconsin

Eligibility Criteria

This trial is for adults over 18 with multiple myeloma who haven't had a relapse or progression before hematopoietic cell transplant (HCT), can attend outpatient sessions, and are okay with surveys and blood draws. They must have started anti-myeloma therapy within the last year, be physically well enough to undergo a specific chemo regimen, and have an adequate stem cell graft. Those with prior HCTs, outpatient HCTs, amyloidosis, or known sleep apnea cannot join.

Inclusion Criteria

I can receive a high-dose chemotherapy treatment.

I started treatment for myeloma less than a year ago.

I am able to care for myself but may not be able to do active work.

Exclusion Criteria

I have had a stem cell transplant using my own cells.

I am receiving stem cell transplant treatments as an outpatient.

I have been diagnosed with amyloidosis alongside my primary condition.

Treatment Details

Interventions

• Mindfulness Awareness Practices for Insomnia (MAP-I) (Behavioral Intervention)
• Sleep Health Information (Behavioral Intervention)

Trial Overview The study compares Mindfulness Awareness Practices for Insomnia (MAP-I) against sleep health education in patients undergoing autologous HCT for multiple myeloma. It's randomized: participants don't choose which group they're in but are assigned by chance to either learn mindfulness techniques aimed at improving sleep or receive educational information about good sleep practices.

Participant Groups

Group I: Mindfulness Awareness Practices for Insomnia Experimental Treatment 1 Intervention

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 II: Sleep Health Education Active Control 1 Intervention

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.

Who Is Running the Clinical Trial?

Medical College of Wisconsin

Lead Sponsor

Trials

645

Recruited

1,180,000+