Effect of Sleep Quality on Hematopoietic Cell Transplant Patient Outcomes

Multiple Myeloma Clinical Trial

Official title:

Mindfulness Meditation and Sleep Disturbances in Hematopoietic Cell Transplant Patients: Inflammatory Mechanisms

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04271930
• Other study ID #: PRO00036928
• Status: Recruiting
• Phase: N/A
• Start date: November 1, 2020
• Est. completion date: March 2025

Study information

• Verified date: September 2023
• Source: Medical College of Wisconsin
• Contact: Cancer Center Clinical Trials Office
• Phone: 866-680-0505
• Email: cccto[@]mcw.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 7
• Est. completion date: March 2025
• Est. primary completion date: September 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Multiple Myeloma
• Sleep

Intervention

Behavioral:
• 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.
• 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.

Locations

Country	Name	City	State
United States	Froedtert Hospital and the Medical College of Wisconsin	Milwaukee	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
Medical College of Wisconsin

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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