Music During Allogeneic Stem Cell Transplant Hospitalization

NCT06679530 | Active Not Recruiting

• 1 other identifier: 24-0862.cc
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this trial is to develop an Independent Music Listening tool for stem cell transplant patients that have prolonged hospitalizations. The main questions it aims to answer are: \[primary hypothesis or outcome measure 1\]? \[primary hypothesis or outcome measure 2\]? Participants will use a self-guided music listening intervention of 1-hour daily music listening during their inpatient hsopitalization and delivered via web-based platform.

Conditions

Hematopoietic Cell Transplantation (HCT)

Outcome Measures

Primary Outcomes (2)

• Feasibility of Intervention Measure (FIM): Mindful Music Listening Group mean >=4 at follow-up

  Feasibility of Intervention Measure (FIM): The FIM has 4 items ranging from 1 (Completely Disagree) to 5 (Completely Agree). Higher scores indicate greater feasibility. Mindful Music Listening (MML) group mean score \>=4 (reflective of an average response of "Agree") at post-intervention will be considered the benchmark for determining that the intervention was feasible, acceptable, and/or appropriate.

  Post-intervention follow-up at 4 weeks post inpatient admission

• Acceptability of Intervention Measure (AIM): Mindful Music Listening Group mean >=4 at follow-up

  Acceptability of Implementation Measure (AIM): The Implementation Appropriateness Measure (IAM) (Weiner et al., 2017) Higher scores indicate greater appropriateness. Mindful Music Listening (MML) group mean score \>=4 (reflective of an average response of "Agree") at post-intervention will be considered the benchmark for determining that the intervention was feasible, acceptable, and/or appropriate.

  Post-intervention follow-up at 4 weeks post inpatient admission

Secondary Outcomes (3)

• Functional Assessment of Cancer Therapy - Bone Marrow Transplant (FACT-BMT)

  Post-intervention follow-up at 4 weeks post inpatient admission

• Hospital Anxiety and Depression Scale (HADS) - Anxiety Subscale (HADS-A total score) and Depression Subscale (HADS-D total score)

  Post-intervention follow-up at 4 weeks post inpatient admission

• Five Facet Mindfulness Questionnaire- 15 item short form (FFMQ-15)

  Post-intervention follow-up at 4 weeks post inpatient admission

Study Arms (2)

Music Intervention

EXPERIMENTAL

Other: Mindful Music Listening (MML)

Control

NO INTERVENTION

Interventions

Mindful Music Listening (MML) OTHER

Self-guided mindful music listening intervention comprised of 1-hour daily music listening during inpatient hospitalization.

Music Intervention

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participate patients need to be (a) diagnosed with a disorder that requires an allogeneic stem cell transplant, (b) scheduled for allogeneic stem cell transplant and expected to be admitted for \~3-4 weeks
• Aged 18 years or older
• Score ≥1 on the distress thermometer
• Have access to a smartphone, tablet, or computer with internet capability in order to complete study surveys via Microsoft Forms and to connect to a music streaming platform via website or app
• Able to provide informed consent.

You may not qualify if:

• Individuals with significant and active cognitive (e.g., major cognitive impairment), psychiatric (e.g., active psychosis), or medical conditions (e.g., untreated significant hearing impairments) that would prevent the ability to provide informed consent or participate in the music listening intervention
• Individuals without access to music streaming via smartphone, tablet, or computer and have access to internet.

Sponsors & Collaborators

• University of Colorado, Denver: lead

Study Sites (1)

University of Colorado Anschutz Medical Campus

Aurora, Colorado, 80045, United States

Location

Study Officials

• Maria Olex, Psy.D.

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants will be randomly assigned to one of two groups including mindful music listening or standard care.

Study Record Dates

• First Submitted: November 5, 2024
• First Posted: November 7, 2024
• Study Start: February 7, 2025
• Primary Completion: March 31, 2026
• Study Completion (Estimated): December 25, 2027
• Last Updated: April 2, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)