Music During Allogeneic Stem Cell Transplant Hospitalization

University of Colorado Denver (CU Denver)

Status: Active, not recruiting

Conditions: Hematopoietic Cell Transplantation (HCT)

Treatments: Other: Mindful Music Listening (MML)

Study type: Interventional

Funder types: Other

Identifiers

NCT06679530

24-0862.cc

Details and patient eligibility

About

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.

Full 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.

Enrollment: 35 estimated patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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35 participants in 2 patient groups

Music Intervention

Experimental group

Treatment:

Other: Mindful Music Listening (MML)

Control

No Intervention group