Music During Allogeneic Stem Cell Transplant Hospitalization

Music During Allogeneic Stem Cell Transplant Hospitalization: A Pilot Trial

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Hematopoietic Cell Transplantation (HCT)
• Intervention / Treatment: Other: Mindful Music Listening (MML)

Detailed Description

To address this clinical and research need in the current project, the primary aim is to (1) assess the feasibility, acceptability, and appropriateness of a self-guided music listening intervention (i.e. Independent Music Listening or "IML") comprised of 1-hour daily music listening during the inpatient hospitalization (e.g., 3-4 weeks) and delivered via web-based platform/smart phone app (e.g., Spotify or Apple music) among 35 HCT patients. Participants will be randomized to IML (n=23) or usual care control group (n=12). The secondary aims are to (2a) explore whether the IML program is associated with improvements on psychosocial self-report measures of patient quality of life, distress, and mindfulness and (2b) whether preliminary psychosocial effects of the IML program are different from a control group of patients completing usual care. In an exploratory aim, the PI will gather qualitative data on patient perceptions and reactions to daily music listening via a daily music diary and post-intervention open-ended questions. Data produced from the current study will help inform development of future interventions to improve quality of life in HCT patients that are based in arts in medicine or creative arts therapy modalities.

• Study Type: Interventional
• Enrollment (Estimated): 35
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Aurora, Colorado, United States, 80045
      • University of Colorado Anschutz Medical Campus

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. 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
2. Aged 18 years or older
3. Score ≥1 on the distress thermometer
4. 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
5. Able to provide informed consent.

Exclusion Criteria:

1. 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
2. Individuals without access to music streaming via smartphone, tablet, or computer and have access to internet.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control
Experimental: Music Intervention	Other: Mindful Music Listening (MML); Self-guided mindful music listening intervention comprised of 1-hour daily music listening during inpatient hospitalization.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Five Facet Mindfulness Questionnaire- 15 item short form (FFMQ-15)	The Five Facet Mindfulness Questionnaire (FFMQ-15) is a short form (15 items) of the 39-item FFMQ (Baer et al., 2006). It includes the same five facets as the long form: Observing, Describing, Acting with Awareness, Non-Judging of inner experience, and Non-Reactivity to inner experience. The 15 question self-report scale measures mindfulness with regards to thoughts, experiences, and actions in daily life (Baer, Carmody, & Hunsinger, 2012). The questions are scored on a 1-5 Likert scale from "never or very rarely true" to "very often or always true." Higher scores are indicative of someone who is more mindful in their everyday life. The factor structure and psychometric properties of the FFMQ-15 were tested by Gu et al. (2016). This questionnaire will be used to illustrate whether participants that are more mindful in their everyday lives respond more to a music listening intervention and whether the intervention impacts their ability to be mindful.	Post-intervention follow-up at 4 weeks post inpatient admission
Functional Assessment of Cancer Therapy - Bone Marrow Transplant (FACT-BMT)	To measure physical, emotional, functional, and social well-being the Functional Assessment of Cancer Therapy - Bone Marrow Transplantation (FACT-BMT (Version 4)) will be used. The study team chose the FACT-BMT because it contains FACT-G (a cancer specific health-related quality of life measure) and additional BMT-specific items. It contains a total of 47 items that are separated into the following domains and scored on a Likert scale: physical well-being, social and family well-being, relationship with doctor, emotional well-being, functional well-being, and additional concerns. This measure is used on patients receiving an autologous or allogeneic HSCT to treat a hematological condition.	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)	The Hospital Anxiety and Depression Scale (HADS) is a validated means of measuring symptoms of depression and anxiety. It consists of 14 items (7 items for each subscale) on a 4-point Likert scale (ranging from 0-3). The total score is the sum of the 14 items, and for each subscale the score is the sum of the respective seven items (ranging from 0-21). After adjusting for six items that are reversed scored, all responses are summed to obtain the two subscales. A cut-off score of 8 is utilized (Bjelland, Dahl, Haug, & Neckelmann, 2002). The scale was chosen because it does not include somatic aspects of depression (e.g., insomnia and weight loss) which are often present in patients diagnosed with blood cancers, rather the scale is focused on anhedonia. Overall, it has demonstrated satisfactory psychometric properties in various groups including cancer inpatients (Annunziata, Muzzatti, & Altoè, 2011).	Post-intervention follow-up at 4 weeks post inpatient admission

Collaborators and Investigators

• Sponsor: University of Colorado, Denver
• Investigators: Principal Investigator: Maria Olex, Psy.D., University of Colorado, Denver

Study record dates

Study Major Dates

• Study Start (Actual): February 7, 2025
• Primary Completion (Actual): March 31, 2026
• Study Completion (Estimated): December 25, 2027

Study Registration Dates

• First Submitted: November 5, 2024
• First Submitted That Met QC Criteria: November 5, 2024
• First Posted (Actual): November 7, 2024

Study Record Updates

• Last Update Posted (Actual): April 2, 2026
• Last Update Submitted That Met QC Criteria: April 1, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: 24-0862.cc

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No