Hematopoietic Cell Transplantation (HCT)NCT06679530
Music During Allogeneic Stem Cell Transplant Hospitalization
A study testing Mindful Music Listening (MML) in people with Hematopoietic Cell Transplantation (HCT), run by University of Colorado, Denver at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Hematopoietic Cell Transplantation (HCT)
- What is being tested?
- Mindful Music Listening (MML)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Feb 2025to 25 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Colorado Anschutz Medical Campus
Aurora, Colorado, 80045
About this study
Official title: 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.
Read the 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.
- Conditions
- Hematopoietic Cell Transplantation (HCT)
- Being tested
- Mindful Music Listening (MML)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindful Music Listening (MML)Other
Self-guided mindful music listening intervention comprised of 1-hour daily music listening during inpatient hospitalization.
| Study group | Role | What they receive |
|---|---|---|
| Music Intervention | Experimental | Not described Receives: Other: Mindful Music Listening (MML) |
| Control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Post-intervention follow-up at 4 weeks post inpatient admission
Secondary outcomes (3)
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.
Measured: 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).
Measured: Post-intervention follow-up at 4 weeks post inpatient admission
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.
Measured: Post-intervention follow-up at 4 weeks post inpatient admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2024
- Study start7 Feb 2025
- Primary completion31 Mar 2026
- Study completion25 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hematopoietic Cell Transplantation (HCT)Studies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomly assigned to one of two groups including mindful music listening or standard care.
- Masking
- None (open label)
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Maria Olex, Psy.D., Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06679530
- Sponsor's protocol ID
- 24-0862.cc
- Status last verified
- Apr 2026
- First submitted
- 5 Nov 2024
- Last updated
- 2 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Music During Allogeneic Stem Cell Transplant Hospitalization: A Pilot Trial
- ClinicalTrials.gov ID
- NCT06679530
- Acronym / sponsor ID
- 24-0862.cc
- Conditions
- Hematopoietic Cell Transplantation (HCT)
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Study start
- 7 Feb 2025 (actual)
- Primary completion
- 31 Mar 2026 (actual)
- Study completion
- 25 Dec 2027 (estimated)
- First posted
- 7 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will be randomly assigned to one of two groups including mindful music listening or standard care.
| Arm | Type | Receives |
|---|---|---|
| Music Intervention | Experimental | Other: Mindful Music Listening (MML) |
| Control | No intervention | – |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mindful Music Listening (MML)Self-guided mindful music listening intervention comprised of 1-hour daily music listening during inpatient hospitalization. | Other | Music Intervention |
Primary outcome
Feasibility of Intervention Measure (FIM): Mindful Music Listening Group mean >=4 at follow-up
Time frame: Post-intervention follow-up at 4 weeks post inpatient admission
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.
Acceptability of Intervention Measure (AIM): Mindful Music Listening Group mean >=4 at follow-up
Time frame: Post-intervention follow-up at 4 weeks post inpatient admission
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.
3 secondary outcomes
Functional Assessment of Cancer Therapy - Bone Marrow Transplant (FACT-BMT)
Time frame: 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)
Time frame: Post-intervention follow-up at 4 weeks post inpatient admission
Five Facet Mindfulness Questionnaire- 15 item short form (FFMQ-15)
Time frame: Post-intervention follow-up at 4 weeks post inpatient admission
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maria Olex, Psy.D. principal investigator
University of Colorado, Denver
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindful Music Listening (MML) in people with Hematopoietic Cell Transplantation (HCT), run by University of Colorado, Denver at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 2 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of Intervention Measure (FIM): Mindful Music Listening Group mean >=4 at follow-up (time frame: Post-intervention follow-up at 4 weeks post inpatient admission). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2026; AzTrials last refreshed its copy on 6 Nov 2026.