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Behavioral Intervention

Mindfulness for Insomnia in Multiple Myeloma Patients

N/A
Recruiting
Led By Jennifer Knight, MD
Research Sponsored by Medical College of Wisconsin
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patient should be eligible to receive melphalan 200 mg/m2 as conditioning regimen
Karnofsky Performance Score (KPS) ≥70
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 100 days after transplant procedure
Awards & highlights

Study Summary

This trial will compare a mindfulness-based insomnia treatment to sleep education in people undergoing stem cell transplants for multiple myeloma.

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Potential side effects from MAP-I may include temporary discomfort like anxiety during practice or frustration if immediate improvements in sleep aren't seen. Sleep health education should not cause any direct side effects.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I can receive a high-dose chemotherapy treatment.
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I am able to care for myself but may not be able to do active work.
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My stem cell graft has enough CD34+ cells for a transplant.
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I can attend the outpatient treatment sessions.
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My myeloma has not worsened or returned before stem cell transplant.
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I am 18 years old or older.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~100 days after transplant procedure
This trial's timeline: 3 weeks for screening, Varies for treatment, and 100 days after transplant procedure for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of Participants Completing Study Procedures
Number of Participants Enrolling in the Study

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Mindfulness Awareness Practices for InsomniaExperimental Treatment1 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 EducationActive Control1 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.

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Who is running the clinical trial?

Medical College of WisconsinLead Sponsor
610 Previous Clinical Trials
1,162,522 Total Patients Enrolled
16 Trials studying Multiple Myeloma
1,719 Patients Enrolled for Multiple Myeloma
Jennifer Knight, MDPrincipal InvestigatorMedical College of Wisconsin
3 Previous Clinical Trials
95 Total Patients Enrolled
1 Trials studying Multiple Myeloma
25 Patients Enrolled for Multiple Myeloma

Media Library

Mindfulness Awareness Practices for Insomnia (MAP-I) (Behavioral Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT04271930 — N/A
Multiple Myeloma Research Study Groups: Mindfulness Awareness Practices for Insomnia, Sleep Health Education
Multiple Myeloma Clinical Trial 2023: Mindfulness Awareness Practices for Insomnia (MAP-I) Highlights & Side Effects. Trial Name: NCT04271930 — N/A
Mindfulness Awareness Practices for Insomnia (MAP-I) (Behavioral Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04271930 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants are accepted in this medical research study?

"Affirmative. The information provided on clinicaltrials.gov confirms that this research study began recruiting participants on November 1st 2020 and is still actively looking for 60 patients at one specific location."

Answered by AI

Does this clinical research program still accept participants?

"Affirmative. According to clinicaltrials.gov, this medical investigation was initially posted on November 1st 2020 and is actively recruiting patients. 60 individuals are required from one centre in order for the trial to reach its goals."

Answered by AI
~0 spots leftby Sep 2024