Trial Outcomes & Findings for Electronic Health Mindfulness-based Music Therapy Intervention for Patients Undergoing Allogeneic Stem Cell Transplantation (NCT NCT05968963)
NCT ID: NCT05968963
Last Updated: 2026-08-12
Results Overview
Scores per item range from 1 to 5. Higher scores indicate more satisfaction. Weekly satisfaction ratings were averaged across the intervention period to yield a single composite score per participant.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
61 participants
Primary outcome timeframe
Up to 100 days post-transplant
Results posted on
2026-08-12
Participant Flow
Participant milestones
| Measure |
Mindfulness-based Music Therapy (MBMT)
Participants will be in the MBMT group for 5 months.
Mindfulness-based Music Therapy (MBMT): Participants will receive 8 music therapy sessions that will last approximately 60 minutes in length. A Music therapist will conduct the sessions. These sessions will be in person and/or virtual depending on patient status and the time between sessions will vary based on patient response to treatment.
|
Mindfulness Meditation (MM)
Participants will be in the MM group for 5 months.
Mindfulness Meditation (MM): Participants will receive 8 mindfulness meditation sessions that will last approximately 60 minutes in length. These sessions will be participant led virtually.
|
|---|---|---|
|
Overall Study
STARTED
|
31
|
30
|
|
Overall Study
COMPLETED
|
20
|
18
|
|
Overall Study
NOT COMPLETED
|
11
|
12
|
Reasons for withdrawal
| Measure |
Mindfulness-based Music Therapy (MBMT)
Participants will be in the MBMT group for 5 months.
Mindfulness-based Music Therapy (MBMT): Participants will receive 8 music therapy sessions that will last approximately 60 minutes in length. A Music therapist will conduct the sessions. These sessions will be in person and/or virtual depending on patient status and the time between sessions will vary based on patient response to treatment.
|
Mindfulness Meditation (MM)
Participants will be in the MM group for 5 months.
Mindfulness Meditation (MM): Participants will receive 8 mindfulness meditation sessions that will last approximately 60 minutes in length. These sessions will be participant led virtually.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
|
Overall Study
Lost to Follow-up
|
10
|
12
|
Baseline Characteristics
Electronic Health Mindfulness-based Music Therapy Intervention for Patients Undergoing Allogeneic Stem Cell Transplantation
Baseline characteristics by cohort
| Measure |
Mindfulness-based Music Therapy (MBMT)
n=31 Participants
Participants will be in the MBMT group for 5 months.
Mindfulness-based Music Therapy (MBMT): Participants will receive 8 music therapy sessions that will last approximately 60 minutes in length. A Music therapist will conduct the sessions. These sessions will be in person and/or virtual depending on patient status and the time between sessions will vary based on patient response to treatment.
|
Mindfulness Meditation (MM)
n=30 Participants
Participants will be in the MM group for 5 months.
Mindfulness Meditation (MM): Participants will receive 8 mindfulness meditation sessions that will last approximately 60 minutes in length. These sessions will be participant led virtually.
|
Total
n=61 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
53 years
STANDARD_DEVIATION 14.59 • n=1 Participants
|
55 years
STANDARD_DEVIATION 14.36 • n=1 Participants
|
53.9 years
STANDARD_DEVIATION 14.38 • n=1 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=1 Participants
|
11 Participants
n=1 Participants
|
26 Participants
n=1 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=1 Participants
|
19 Participants
n=1 Participants
|
35 Participants
n=1 Participants
|
|
Race/Ethnicity, Customized
White/Caucasian
|
20 Participants
n=1 Participants
|
18 Participants
n=1 Participants
|
38 Participants
n=1 Participants
|
|
Race/Ethnicity, Customized
Black/African American
|
5 Participants
n=1 Participants
|
5 Participants
n=1 Participants
|
10 Participants
n=1 Participants
|
|
Race/Ethnicity, Customized
Other
|
5 Participants
n=1 Participants
|
1 Participants
n=1 Participants
|
6 Participants
n=1 Participants
|
|
Race/Ethnicity, Customized
Missing
|
1 Participants
n=1 Participants
|
6 Participants
n=1 Participants
|
7 Participants
n=1 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
11 Participants
n=1 Participants
|
12 Participants
n=1 Participants
|
23 Participants
n=1 Participants
|
|
Race/Ethnicity, Customized
Non-Hispanic
|
20 Participants
n=1 Participants
|
17 Participants
n=1 Participants
|
37 Participants
n=1 Participants
|
|
Marital Status
Married/In a relationship
|
21 Participants
n=1 Participants
|
15 Participants
n=1 Participants
|
36 Participants
n=1 Participants
|
|
Marital Status
Single/Never married
|
5 Participants
n=1 Participants
|
7 Participants
n=1 Participants
|
12 Participants
n=1 Participants
|
|
Marital Status
Separated/Divorced/Widowed
|
3 Participants
n=1 Participants
|
4 Participants
n=1 Participants
|
7 Participants
n=1 Participants
|
|
Marital Status
Missing
|
2 Participants
n=1 Participants
|
4 Participants
n=1 Participants
|
6 Participants
n=1 Participants
|
|
Primary Language
English only
|
15 Participants
n=1 Participants
|
15 Participants
n=1 Participants
|
30 Participants
n=1 Participants
|
|
Primary Language
Spanish only
|
9 Participants
n=1 Participants
|
7 Participants
n=1 Participants
|
16 Participants
n=1 Participants
|
|
Primary Language
English and Spanish
|
3 Participants
n=1 Participants
|
5 Participants
n=1 Participants
|
8 Participants
n=1 Participants
|
|
Primary Language
Missing
|
4 Participants
n=1 Participants
|
3 Participants
n=1 Participants
|
7 Participants
n=1 Participants
|
|
Cancer Type
Acute Myeloid Leukemia
|
10 Participants
n=1 Participants
|
11 Participants
n=1 Participants
|
21 Participants
n=1 Participants
|
|
Cancer Type
Acute Lymphoblastic Leukemia
|
5 Participants
n=1 Participants
|
5 Participants
n=1 Participants
|
10 Participants
n=1 Participants
|
|
Cancer Type
Non-Hodgkin's Lymphoma
|
5 Participants
n=1 Participants
|
4 Participants
n=1 Participants
|
9 Participants
n=1 Participants
|
|
Cancer Type
Hodgkin's Lymphoma
|
4 Participants
n=1 Participants
|
2 Participants
n=1 Participants
|
6 Participants
n=1 Participants
|
|
Cancer Type
Myelodysplastic syndrome
|
3 Participants
n=1 Participants
|
2 Participants
n=1 Participants
|
5 Participants
n=1 Participants
|
|
Cancer Type
Other
|
4 Participants
n=1 Participants
|
5 Participants
n=1 Participants
|
9 Participants
n=1 Participants
|
|
Cancer Type
Missing
|
0 Participants
n=1 Participants
|
1 Participants
n=1 Participants
|
1 Participants
n=1 Participants
|
|
Stem Cell Transplan Type
Allogeneic
|
23 Participants
n=1 Participants
|
25 Participants
n=1 Participants
|
48 Participants
n=1 Participants
|
|
Stem Cell Transplan Type
Autologous
|
7 Participants
n=1 Participants
|
4 Participants
n=1 Participants
|
11 Participants
n=1 Participants
|
|
Stem Cell Transplan Type
No transplant
|
1 Participants
n=1 Participants
|
0 Participants
n=1 Participants
|
1 Participants
n=1 Participants
|
|
Stem Cell Transplan Type
Missing
|
0 Participants
n=1 Participants
|
1 Participants
n=1 Participants
|
1 Participants
n=1 Participants
|
PRIMARY outcome
Timeframe: Baseline (T1)Population: Overall Number of Participants Analyzed reflects all participants enrolled and randomized into the study.
Recruitment will be measured by the count of participants successfully enrolled and randomized into the study.
Outcome measures
| Measure |
Mindfulness Meditation (MM)
n=30 Participants
Participants will be in the MM group for 5 months.
Mindfulness Meditation (MM): Participants will receive 8 mindfulness meditation sessions that will last approximately 60 minutes in length. These sessions will be participant led virtually.
|
Mindfulness-based Music Therapy (MBMT)
n=31 Participants
Participants will be in the MBMT group for 5 months.
Mindfulness-based Music Therapy (MBMT): Participants will receive 8 music therapy sessions that will last approximately 60 minutes in length. A Music therapist will conduct the sessions. These sessions will be in person and/or virtual depending on patient status and the time between sessions will vary based on patient response to treatment.
|
|---|---|---|
|
Count of Participants Recruited
|
30 Participants
|
31 Participants
|
PRIMARY outcome
Timeframe: Up to 18 monthsPopulation: Overall Number of Participants Analyzed reflects all participants enrolled and randomized. Retention was defined as remaining in the study through the 18-month time frame
Participant retention will be examined via the number of participants retained in the study.
Outcome measures
| Measure |
Mindfulness Meditation (MM)
n=30 Participants
Participants will be in the MM group for 5 months.
Mindfulness Meditation (MM): Participants will receive 8 mindfulness meditation sessions that will last approximately 60 minutes in length. These sessions will be participant led virtually.
|
Mindfulness-based Music Therapy (MBMT)
n=31 Participants
Participants will be in the MBMT group for 5 months.
Mindfulness-based Music Therapy (MBMT): Participants will receive 8 music therapy sessions that will last approximately 60 minutes in length. A Music therapist will conduct the sessions. These sessions will be in person and/or virtual depending on patient status and the time between sessions will vary based on patient response to treatment.
|
|---|---|---|
|
Number of Participants Retained
|
18 Participants
|
20 Participants
|
PRIMARY outcome
Timeframe: Up to 100 days post-transplantPopulation: Outcome was reported only for the MBMT intervention; no outcome was reported for MM because participants completed it independently, without structured oversight.
Participant engagement will be examined via the mean number of intervention sessions completed by participants measured after the 8th (and last) intervention session which is given between 75 and 100 days post-transplant.
Outcome measures
| Measure |
Mindfulness Meditation (MM)
Participants will be in the MM group for 5 months.
Mindfulness Meditation (MM): Participants will receive 8 mindfulness meditation sessions that will last approximately 60 minutes in length. These sessions will be participant led virtually.
|
Mindfulness-based Music Therapy (MBMT)
n=31 Participants
Participants will be in the MBMT group for 5 months.
Mindfulness-based Music Therapy (MBMT): Participants will receive 8 music therapy sessions that will last approximately 60 minutes in length. A Music therapist will conduct the sessions. These sessions will be in person and/or virtual depending on patient status and the time between sessions will vary based on patient response to treatment.
|
|---|---|---|
|
Mean Number of Intervention Sessions That Participants Completed
|
—
|
6.0 Sessions completed
Standard Deviation 2.41
|
PRIMARY outcome
Timeframe: Up to 100 days post-transplantPopulation: Outcome was reported only for the MBMT intervention; no outcome was reported for MM because participants completed it independently, without structured oversight.
Scores per item range from 1 to 5. Higher scores indicate more satisfaction. Weekly satisfaction ratings were averaged across the intervention period to yield a single composite score per participant.
Outcome measures
| Measure |
Mindfulness Meditation (MM)
Participants will be in the MM group for 5 months.
Mindfulness Meditation (MM): Participants will receive 8 mindfulness meditation sessions that will last approximately 60 minutes in length. These sessions will be participant led virtually.
|
Mindfulness-based Music Therapy (MBMT)
n=31 Participants
Participants will be in the MBMT group for 5 months.
Mindfulness-based Music Therapy (MBMT): Participants will receive 8 music therapy sessions that will last approximately 60 minutes in length. A Music therapist will conduct the sessions. These sessions will be in person and/or virtual depending on patient status and the time between sessions will vary based on patient response to treatment.
|
|---|---|---|
|
Satisfaction Scores as Measured by Weekly Rating Satisfaction Score
|
—
|
4.57 score on a scale (0-5)
Standard Deviation 0.59
|
SECONDARY outcome
Timeframe: Baseline (T1), up to 18 monthsThe Functional Assessment of Cancer Therapy - Bone Marrow Transplant (FACT-BMT) assesses health-related quality of life in bone marrow transplant recipients. Scores range from 0-164, with higher scores indicating better quality of life.
Outcome measures
| Measure |
Mindfulness Meditation (MM)
n=18 Participants
Participants will be in the MM group for 5 months.
Mindfulness Meditation (MM): Participants will receive 8 mindfulness meditation sessions that will last approximately 60 minutes in length. These sessions will be participant led virtually.
|
Mindfulness-based Music Therapy (MBMT)
n=19 Participants
Participants will be in the MBMT group for 5 months.
Mindfulness-based Music Therapy (MBMT): Participants will receive 8 music therapy sessions that will last approximately 60 minutes in length. A Music therapist will conduct the sessions. These sessions will be in person and/or virtual depending on patient status and the time between sessions will vary based on patient response to treatment.
|
|---|---|---|
|
Change in Health Related Quality of Life Scores as Measured by Functional Assessment of Cancer Therapy - Bone Marrow Transplant (FACT-BMT)
|
-3.4 score on a scale
Standard Deviation 15.7
|
-13.1 score on a scale
Standard Deviation 18.7
|
SECONDARY outcome
Timeframe: Baseline (T1), up to 18 monthsPROMIS® Pain Interference Short Form 8a is scored as a T-score, ranging from 40.7 to 77.0, with a mean of 50 and standard deviation of 10 in the general population. Higher scores indicate greater pain interference.
Outcome measures
| Measure |
Mindfulness Meditation (MM)
n=17 Participants
Participants will be in the MM group for 5 months.
Mindfulness Meditation (MM): Participants will receive 8 mindfulness meditation sessions that will last approximately 60 minutes in length. These sessions will be participant led virtually.
|
Mindfulness-based Music Therapy (MBMT)
n=19 Participants
Participants will be in the MBMT group for 5 months.
Mindfulness-based Music Therapy (MBMT): Participants will receive 8 music therapy sessions that will last approximately 60 minutes in length. A Music therapist will conduct the sessions. These sessions will be in person and/or virtual depending on patient status and the time between sessions will vary based on patient response to treatment.
|
|---|---|---|
|
Change in Pain Interference as Measured by Patient Reported Outcome Measures (PROMIS®) Pain Interference Short Form 8a.
|
-1.8 units on a scale
Standard Deviation 8.6
|
4.5 units on a scale
Standard Deviation 11.4
|
SECONDARY outcome
Timeframe: Baseline (T1), up to 18 monthsPROMIS® Fatigue Short Form 8a is scored as a T-score, ranging from 33.1 to 77.8, with a mean of 50 and standard deviation of 10 in the general population. Higher scores indicate greater fatigue.
Outcome measures
| Measure |
Mindfulness Meditation (MM)
n=18 Participants
Participants will be in the MM group for 5 months.
Mindfulness Meditation (MM): Participants will receive 8 mindfulness meditation sessions that will last approximately 60 minutes in length. These sessions will be participant led virtually.
|
Mindfulness-based Music Therapy (MBMT)
n=19 Participants
Participants will be in the MBMT group for 5 months.
Mindfulness-based Music Therapy (MBMT): Participants will receive 8 music therapy sessions that will last approximately 60 minutes in length. A Music therapist will conduct the sessions. These sessions will be in person and/or virtual depending on patient status and the time between sessions will vary based on patient response to treatment.
|
|---|---|---|
|
Change in Fatigue as Measured by Patient Reported Outcome Measures (PROMIS®) Fatigue Short Form 8a.
|
-0.0 units on a scale
Standard Deviation 8.6
|
4.6 units on a scale
Standard Deviation 9.7
|
SECONDARY outcome
Timeframe: Baseline (T1), up to 18 monthsFast Cognitive Evaluation (FaCE) score range from 0 to 27. Higher score indicates better cognitive function.
Outcome measures
| Measure |
Mindfulness Meditation (MM)
n=9 Participants
Participants will be in the MM group for 5 months.
Mindfulness Meditation (MM): Participants will receive 8 mindfulness meditation sessions that will last approximately 60 minutes in length. These sessions will be participant led virtually.
|
Mindfulness-based Music Therapy (MBMT)
n=11 Participants
Participants will be in the MBMT group for 5 months.
Mindfulness-based Music Therapy (MBMT): Participants will receive 8 music therapy sessions that will last approximately 60 minutes in length. A Music therapist will conduct the sessions. These sessions will be in person and/or virtual depending on patient status and the time between sessions will vary based on patient response to treatment.
|
|---|---|---|
|
Change in Cognitive Function Scores as Measured by Fast Cognitive Evaluation
|
-1.3 score on a scale
Standard Deviation 1.8
|
-1.1 score on a scale
Standard Deviation 2.5
|
SECONDARY outcome
Timeframe: Baseline (T1), up to 18 monthsPittsburgh Sleep Quality Index score range from 0 to 21. Higher score indicate worse sleep quality.
Outcome measures
| Measure |
Mindfulness Meditation (MM)
n=17 Participants
Participants will be in the MM group for 5 months.
Mindfulness Meditation (MM): Participants will receive 8 mindfulness meditation sessions that will last approximately 60 minutes in length. These sessions will be participant led virtually.
|
Mindfulness-based Music Therapy (MBMT)
n=19 Participants
Participants will be in the MBMT group for 5 months.
Mindfulness-based Music Therapy (MBMT): Participants will receive 8 music therapy sessions that will last approximately 60 minutes in length. A Music therapist will conduct the sessions. These sessions will be in person and/or virtual depending on patient status and the time between sessions will vary based on patient response to treatment.
|
|---|---|---|
|
Change in Sleep Quality Scores as Measured by Pittsburgh Sleep Quality Index
|
0.5 score on a scale
Standard Deviation 3.8
|
0.6 score on a scale
Standard Deviation 2.9
|
SECONDARY outcome
Timeframe: Up to 18 monthsTo measure the number of days to engraftment we will extract from the electronic medical record (EMR) days from infusion to engraftment.
Outcome measures
| Measure |
Mindfulness Meditation (MM)
n=28 Participants
Participants will be in the MM group for 5 months.
Mindfulness Meditation (MM): Participants will receive 8 mindfulness meditation sessions that will last approximately 60 minutes in length. These sessions will be participant led virtually.
|
Mindfulness-based Music Therapy (MBMT)
n=30 Participants
Participants will be in the MBMT group for 5 months.
Mindfulness-based Music Therapy (MBMT): Participants will receive 8 music therapy sessions that will last approximately 60 minutes in length. A Music therapist will conduct the sessions. These sessions will be in person and/or virtual depending on patient status and the time between sessions will vary based on patient response to treatment.
|
|---|---|---|
|
Number of Days to Engraftment Measured From Infusion to Engraftment.
|
16 days
Standard Deviation 4
|
14 days
Standard Deviation 5
|
SECONDARY outcome
Timeframe: Up to 18 monthsTo measure the number of days of hospitalization we will extract from the electronic medical record (EMR) days of hospitalization from admission to engraftment.
Outcome measures
| Measure |
Mindfulness Meditation (MM)
n=29 Participants
Participants will be in the MM group for 5 months.
Mindfulness Meditation (MM): Participants will receive 8 mindfulness meditation sessions that will last approximately 60 minutes in length. These sessions will be participant led virtually.
|
Mindfulness-based Music Therapy (MBMT)
n=31 Participants
Participants will be in the MBMT group for 5 months.
Mindfulness-based Music Therapy (MBMT): Participants will receive 8 music therapy sessions that will last approximately 60 minutes in length. A Music therapist will conduct the sessions. These sessions will be in person and/or virtual depending on patient status and the time between sessions will vary based on patient response to treatment.
|
|---|---|---|
|
Number of Days of Hospitalization Measured From Admission to Engraftment.
|
28.6 days
Standard Deviation 6.63
|
28.5 days
Standard Deviation 8.27
|
SECONDARY outcome
Timeframe: Up to 100 daysTo measure the number of hospital readmissions we will extract from the electronic medical record (EMR) the number of hospital readmissions from hospital discharge.
Outcome measures
| Measure |
Mindfulness Meditation (MM)
n=29 Participants
Participants will be in the MM group for 5 months.
Mindfulness Meditation (MM): Participants will receive 8 mindfulness meditation sessions that will last approximately 60 minutes in length. These sessions will be participant led virtually.
|
Mindfulness-based Music Therapy (MBMT)
n=31 Participants
Participants will be in the MBMT group for 5 months.
Mindfulness-based Music Therapy (MBMT): Participants will receive 8 music therapy sessions that will last approximately 60 minutes in length. A Music therapist will conduct the sessions. These sessions will be in person and/or virtual depending on patient status and the time between sessions will vary based on patient response to treatment.
|
|---|---|---|
|
Number of Hospital Readmissions After Hospital Discharge
0
|
20 Participants
|
18 Participants
|
|
Number of Hospital Readmissions After Hospital Discharge
1
|
5 Participants
|
12 Participants
|
|
Number of Hospital Readmissions After Hospital Discharge
2
|
4 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: up to 100 Days Post-Infusion DayTo measure the number of infections we will extract from the electronic medical record (EMR) the number of infections from hospital admission measure up to 100 days post infusion.
Outcome measures
| Measure |
Mindfulness Meditation (MM)
n=29 Participants
Participants will be in the MM group for 5 months.
Mindfulness Meditation (MM): Participants will receive 8 mindfulness meditation sessions that will last approximately 60 minutes in length. These sessions will be participant led virtually.
|
Mindfulness-based Music Therapy (MBMT)
n=31 Participants
Participants will be in the MBMT group for 5 months.
Mindfulness-based Music Therapy (MBMT): Participants will receive 8 music therapy sessions that will last approximately 60 minutes in length. A Music therapist will conduct the sessions. These sessions will be in person and/or virtual depending on patient status and the time between sessions will vary based on patient response to treatment.
|
|---|---|---|
|
Number of Infections From Hospital Admission
No
|
6 Participants
|
6 Participants
|
|
Number of Infections From Hospital Admission
Yes
|
23 Participants
|
25 Participants
|
SECONDARY outcome
Timeframe: Baseline (T1), up to 18 monthsGeneralized anxiety disorder (GAD-7) range is 0 to 21; higher score is associated with more severe anxiety.
Outcome measures
| Measure |
Mindfulness Meditation (MM)
n=15 Participants
Participants will be in the MM group for 5 months.
Mindfulness Meditation (MM): Participants will receive 8 mindfulness meditation sessions that will last approximately 60 minutes in length. These sessions will be participant led virtually.
|
Mindfulness-based Music Therapy (MBMT)
n=19 Participants
Participants will be in the MBMT group for 5 months.
Mindfulness-based Music Therapy (MBMT): Participants will receive 8 music therapy sessions that will last approximately 60 minutes in length. A Music therapist will conduct the sessions. These sessions will be in person and/or virtual depending on patient status and the time between sessions will vary based on patient response to treatment.
|
|---|---|---|
|
Change in Anxiety Scores as Measured With the Generalized Anxiety Disorder (GAD-7)
|
-1.1 score on a scale
Standard Deviation 2.8
|
0.1 score on a scale
Standard Deviation 3.9
|
SECONDARY outcome
Timeframe: Baseline (T1), up to 18 monthsPHQ-9 (patient health questionnaire) score range is from 0 to 27; higher score is associated with more severe depression.
Outcome measures
| Measure |
Mindfulness Meditation (MM)
n=15 Participants
Participants will be in the MM group for 5 months.
Mindfulness Meditation (MM): Participants will receive 8 mindfulness meditation sessions that will last approximately 60 minutes in length. These sessions will be participant led virtually.
|
Mindfulness-based Music Therapy (MBMT)
n=19 Participants
Participants will be in the MBMT group for 5 months.
Mindfulness-based Music Therapy (MBMT): Participants will receive 8 music therapy sessions that will last approximately 60 minutes in length. A Music therapist will conduct the sessions. These sessions will be in person and/or virtual depending on patient status and the time between sessions will vary based on patient response to treatment.
|
|---|---|---|
|
Changes in Depression Scores as Measured With the Patient Health Questionnaire (PHQ-9)
|
-1.0 score on a scale
Standard Deviation 4.9
|
1.4 score on a scale
Standard Deviation 3.1
|
SECONDARY outcome
Timeframe: Baseline (T1), up to 18 monthsImpact of Events Scale-Revised range is 0 to 88; higher score is associated with more effect caused by events.
Outcome measures
| Measure |
Mindfulness Meditation (MM)
n=15 Participants
Participants will be in the MM group for 5 months.
Mindfulness Meditation (MM): Participants will receive 8 mindfulness meditation sessions that will last approximately 60 minutes in length. These sessions will be participant led virtually.
|
Mindfulness-based Music Therapy (MBMT)
n=19 Participants
Participants will be in the MBMT group for 5 months.
Mindfulness-based Music Therapy (MBMT): Participants will receive 8 music therapy sessions that will last approximately 60 minutes in length. A Music therapist will conduct the sessions. These sessions will be in person and/or virtual depending on patient status and the time between sessions will vary based on patient response to treatment.
|
|---|---|---|
|
Change in Cancer-specific Distress Scores as Measured by the Impact of Events Scale-Revised
|
-3.7 score on a scale
Standard Deviation 9.1
|
-0.9 score on a scale
Standard Deviation 15.8
|
SECONDARY outcome
Timeframe: Baseline (T1), up to 18 monthsSerum cortisol levels are measured via ELISA. Serum Cortisol normal levels morning range: 10-20 mcg/dL ; afternoon range: 3-10 mcg/dL. Any values outside of the range are associated with higher stress and inflammation
Outcome measures
| Measure |
Mindfulness Meditation (MM)
n=12 Participants
Participants will be in the MM group for 5 months.
Mindfulness Meditation (MM): Participants will receive 8 mindfulness meditation sessions that will last approximately 60 minutes in length. These sessions will be participant led virtually.
|
Mindfulness-based Music Therapy (MBMT)
n=14 Participants
Participants will be in the MBMT group for 5 months.
Mindfulness-based Music Therapy (MBMT): Participants will receive 8 music therapy sessions that will last approximately 60 minutes in length. A Music therapist will conduct the sessions. These sessions will be in person and/or virtual depending on patient status and the time between sessions will vary based on patient response to treatment.
|
|---|---|---|
|
Change in Serum Cortisol as Measured by ELISA
|
-0.7 mcg/dL
Standard Deviation 10.4
|
4.2 mcg/dL
Standard Deviation 5.4
|
SECONDARY outcome
Timeframe: Baseline (T1), up to 18 monthsCytokines levels are measured in pg/mL. Any values outside of the normal range are associated with inflammation
Outcome measures
| Measure |
Mindfulness Meditation (MM)
n=12 Participants
Participants will be in the MM group for 5 months.
Mindfulness Meditation (MM): Participants will receive 8 mindfulness meditation sessions that will last approximately 60 minutes in length. These sessions will be participant led virtually.
|
Mindfulness-based Music Therapy (MBMT)
n=14 Participants
Participants will be in the MBMT group for 5 months.
Mindfulness-based Music Therapy (MBMT): Participants will receive 8 music therapy sessions that will last approximately 60 minutes in length. A Music therapist will conduct the sessions. These sessions will be in person and/or virtual depending on patient status and the time between sessions will vary based on patient response to treatment.
|
|---|---|---|
|
Change in Immunocompetence as Measured by Cytokines
IFN-γ
|
0 pg/mL
Standard Deviation 0
|
0 pg/mL
Standard Deviation 0
|
|
Change in Immunocompetence as Measured by Cytokines
TNF-α
|
0.7 pg/mL
Standard Deviation 6.9
|
0.9 pg/mL
Standard Deviation 5.3
|
|
Change in Immunocompetence as Measured by Cytokines
IL-1β
|
-0.4 pg/mL
Standard Deviation 0.9
|
-0.4 pg/mL
Standard Deviation 1.2
|
|
Change in Immunocompetence as Measured by Cytokines
IL-2
|
-0.1 pg/mL
Standard Deviation 0.2
|
-0.0 pg/mL
Standard Deviation 0.3
|
|
Change in Immunocompetence as Measured by Cytokines
IL-4
|
-0.9 pg/mL
Standard Deviation 3.7
|
-0.5 pg/mL
Standard Deviation 6.9
|
|
Change in Immunocompetence as Measured by Cytokines
IL-5
|
0.1 pg/mL
Standard Deviation 0.3
|
-0.0 pg/mL
Standard Deviation 0.2
|
|
Change in Immunocompetence as Measured by Cytokines
IL-6
|
-3.5 pg/mL
Standard Deviation 9.9
|
-2.0 pg/mL
Standard Deviation 7.1
|
|
Change in Immunocompetence as Measured by Cytokines
IL-8
|
-59.3 pg/mL
Standard Deviation 195.8
|
-27.4 pg/mL
Standard Deviation 105.2
|
|
Change in Immunocompetence as Measured by Cytokines
IL-10
|
1.4 pg/mL
Standard Deviation 3.3
|
-0.1 pg/mL
Standard Deviation 1.0
|
|
Change in Immunocompetence as Measured by Cytokines
GMCSF
|
-0.0 pg/mL
Standard Deviation 0.4
|
0.0 pg/mL
Standard Deviation 0.3
|
Adverse Events
Mindfulness-based Music Therapy (MBMT)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Mindfulness Meditation (MM)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place