Clinical trial NCT06679530: Music During Allogeneic Stem Cell Transplant Hospitalization
Official title: Music During Allogeneic Stem Cell Transplant Hospitalization: A Pilot Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hematopoietic Cell Transplantation (HCT)
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
First posted: 2024-11-07
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomly assigned to one of two groups including mindful music listening or standard care.
Primary purpose: SUPPORTIVE_CARE

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Feasibility of Intervention Measure (FIM): Mindful Music Listening Group mean >=4 at follow-up
timeFrame: Post-intervention follow-up at 4 weeks post inpatient admission
measure: Acceptability of Intervention Measure (AIM): Mindful Music Listening Group mean >=4 at follow-up
timeFrame: Post-intervention follow-up at 4 weeks post inpatient admission
Secondary outcomes:
measure: Functional Assessment of Cancer Therapy - Bone Marrow Transplant (FACT-BMT)
timeFrame: Post-intervention follow-up at 4 weeks post inpatient admission
measure: Hospital Anxiety and Depression Scale (HADS) - Anxiety Subscale (HADS-A total score) and Depression Subscale (HADS-D total score)
timeFrame: Post-intervention follow-up at 4 weeks post inpatient admission
measure: Five Facet Mindfulness Questionnaire- 15 item short form (FFMQ-15)
timeFrame: Post-intervention follow-up at 4 weeks post inpatient admission
Other outcomes:
Locations:
city: Aurora
country: United States
facility: University of Colorado Anschutz Medical Campus
state: Colorado
Study officials:
affiliation: University of Colorado, Denver
name: Maria Olex, Psy.D.
role: PRINCIPAL_INVESTIGATOR
References: