Hematopoietic Stem Cell TransplantNCT03378089
Music Therapy and Hematopoietic Stem Cell Transplant
A study testing Music Therapy and No Music Therapy in people with Hematopoietic Stem Cell Transplant, run by Case Comprehensive Cancer Center at 1 site in United States.
Trial summary
The purpose of this randomized, controlled study is to determine the effects of pre-transplant music therapy on mood, distress, and physical functioning variables in patients undergoing Hematopoietic Stem Cell Transplant (HSCT). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hematopoietic Stem Cell Transplant
- What is being tested?
- Music Therapy and No Music Therapy
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Feb 2018to 21 Jun 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients undergoing inpatient allogeneic stem cell transplant
- Must be fluent in English
- Must be able to communicate verbally and have no significant hearing impairment
- Have capacity to provide consent
- All diagnosis, graft source, donor sources will be included.
Who cannot join
- Patients not meeting the above inclusion criteria
Trial locations and contacts
1 site in 1 country.
United States1 site
Cleveland Clinic, Taussig Cancer Institute, Case Comprehensive Cancer Center
Cleveland, Ohio, 44195
About this study
Official title: The Effects of Pre-Transplant Music Therapy for Patients Undergoing Hematopoietic Stem Cell Transplant
The purpose of this randomized, controlled study is to determine the effects of pre-transplant music therapy on mood, distress, and physical functioning variables in patients undergoing Hematopoietic Stem Cell Transplant (HSCT).
Read the detailed description
Primary Endpoint:
Compare the difference in distress via Distress Thermometer for patients who receive music therapy and those who do not.
Secondary Endpoints:
Compare the difference in patient perception of pain, anxiety, and mood via Numeric Rating Scale for patients who receive music therapy and those who do not.
Compare the difference in quality of life via Functional Assessment of Cancer Therapy-General (FACT-G7) for patients who receive music therapy and those who do not.
Compare the difference in the use of total narcotic medications in those who receive music therapy and those who do not (using morphine equivalent doses).
Study Design:
Participants randomized in the experimental group will receive a total of three sessions prior to stem cell infusion day. The first session will occur within 24 hours of admission to the bone marrow transplant (BMT) unit. The second session will occur between 24 - 96 hours after the first session, depending on transplant preparation regimen. The third session will occur on Day -1. For participants in the control group, assessments will be timed to emulate those in the experimental arm.
A decision tree for music therapy interventions will be employed in this study. Participants in the experimental group will be given choices about how to proceed with the session: active or passive, improvisation, re-creative or receptive songs, or receptive (relaxation).
Participants randomized to the standard care group will be asked to rate the same symptoms as those in the experimental group. This will mark the beginning of a 45-minute control condition period during which the participants may fill the 45-minute time-period in whatever ways they choose, however, they will be asked to refrain from listening to recorded music during this time. At the conclusion of 45-minutes, post-condition data will be collected.
- Conditions
- Hematopoietic Stem Cell Transplant
- Being tested
- Music Therapy, No Music Therapy
- Keywords
- Music Therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Music TherapyBehavioural
No narcotic or anti-emetic therapy will be administered for at least 2 hours prior to music therapy session. Music therapy sessions will be administered by a board certified music therapist (MT-BC) and last approximately 45 minutes. Involvement in sessions will be based on therapist and patient availability.
No Music TherapyBehavioural
Participants will fill the same 45 minute period in any way they choose; however, they will be asked to refrain from listening to recorded music during this time.
| Study group | Role | What they receive |
|---|---|---|
| Music Therapy | Experimental | Participants in the experimental group will be given choices about how to proceed with the session: active or passive, improvisation, re-creative or receptive songs, or receptive (relaxation). Three music therapy sessions will be completed, the first within 24 hours of admission, the second 24-96 hours of session 1, and the final session the day before stem cell infusion. Receives: Behavioral: Music Therapy |
| No Music Therapy | Active comparator | Participants randomized to the standard care group will be asked to rate the same symptoms as those in the experimental group. This will mark the beginning of a 45-minute control condition period during which the participants may fill the 45-minute time-period in whatever ways they choose. Receives: Behavioral: No Music Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Distress Score
Distress Thermometer assessments for both the experimental and standard care group will be given in the mid-late afternoon. This is an analog scale from 0-10 where 0 indicates no distress and 10 indicates extreme distress.
Measured: From admission to day -1 (up to 9 days)
Secondary outcomes (8)
Change in Pain Score
Before and after each music therapy session or control condition, participants will provide self-reported numeric ratings of pain/anxiety. The Numeric Rating Scale will be from 0-10, where 10 is the most pain/anxiety possible.
Measured: Within 24 hours of admission
Change in Pain Score
Before and after each music therapy session or control condition, participants will provide self-reported numeric ratings of pain/anxiety. The Numeric Rating Scale will be from 0-10, where 10 is the most pain/anxiety possible.
Measured: Up to 96 hours after session 1 (120 hours from admission)
Change in Pain Score
Before and after each music therapy session or control condition, participants will provide self-reported numeric ratings of pain/anxiety. The Numeric Rating Scale will be from 0-10, where 10 is the most pain/anxiety possible.
Measured: Up to 24 hours before procedure
Change in Mood Score
Before and after each music therapy session or control condition, participants will report mood using the Rogers Happy/Sad Faces Scale, a five point visual analog scale.
Measured: Within 24 hours of admission
Change in Mood Score
Before and after each music therapy session or control condition, participants will report mood using the Rogers Happy/Sad Faces Scale, a five point visual analog scale.
Measured: Up to 96 hours after session 1 (120 hours from admission)
Change in Mood Score
Before and after each music therapy session or control condition, participants will report mood using the Rogers Happy/Sad Faces Scale, a five point visual analog scale.
Measured: Up to 24 hours before procedure
Change in Quality of Life Score
The FACT-G7 is a seven-item assessment measuring cancer-specific quality of life. Seven items are scored on a 5-point scale (0-4), and patients are asked to indicate responses based on their experiences in the previous 7 days.
Measured: From admission to day -1 (up to 9 days)
Total Narcotic Medication Use
Medication will be extracted from the electronic medical record and converted to morphine equivalent doses.
Measured: From admission to day -1 (up to 9 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2017
- Study start26 Feb 2018
- Primary completion21 Jun 2019
- Study completion21 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hematopoietic Stem Cell TransplantStudies of the same condition, open and under way.
- More trials run by Case Comprehensive Cancer CenterThe 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
- Masking
- None (open label)
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Case Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Navneet Majhail, MD, Principal investigator, Cleveland Clinic, Taussig Cancer Institute, Case Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03378089
- Sponsor's protocol ID
- CASE16Z17
- Status last verified
- Jul 2019
- First submitted
- 15 Dec 2017
- Last updated
- 1 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Pre-Transplant Music Therapy for Patients Undergoing Hematopoietic Stem Cell Transplant
- ClinicalTrials.gov ID
- NCT03378089
- Acronym / sponsor ID
- CASE16Z17
- Conditions
- Hematopoietic Stem Cell Transplant
- Keywords
- Music Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Case Comprehensive Cancer CenterUniversity, hospital or other
- Study start
- 26 Feb 2018 (actual)
- Primary completion
- 21 Jun 2019 (actual)
- Study completion
- 21 Jun 2019 (actual)
- First posted
- 19 Dec 2017 (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 purpose of this randomized, controlled study is to determine the effects of pre-transplant music therapy on mood, distress, and physical functioning variables in patients undergoing Hematopoietic Stem Cell Transplant (HSCT).
Detailed description
Primary Endpoint:
Compare the difference in distress via Distress Thermometer for patients who receive music therapy and those who do not.
Secondary Endpoints:
Compare the difference in patient perception of pain, anxiety, and mood via Numeric Rating Scale for patients who receive music therapy and those who do not.
Compare the difference in quality of life via Functional Assessment of Cancer Therapy-General (FACT-G7) for patients who receive music therapy and those who do not.
Compare the difference in the use of total narcotic medications in those who receive music therapy and those who do not (using morphine equivalent doses).
Study Design:
Participants randomized in the experimental group will receive a total of three sessions prior to stem cell infusion day. The first session will occur within 24 hours of admission to the bone marrow transplant (BMT) unit. The second session will occur between 24 - 96 hours after the first session, depending on transplant preparation regimen. The third session will occur on Day -1. For participants in the control group, assessments will be timed to emulate those in the experimental arm.
A decision tree for music therapy interventions will be employed in this study. Participants in the experimental group will be given choices about how to proceed with the session: active or passive, improvisation, re-creative or receptive songs, or receptive (relaxation).
Participants randomized to the standard care group will be asked to rate the same symptoms as those in the experimental group. This will mark the beginning of a 45-minute control condition period during which the participants may fill the 45-minute time-period in whatever ways they choose, however, they will be asked to refrain from listening to recorded music during this time. At the conclusion of 45-minutes, post-condition data will be collected.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Music Therapy | Experimental | Behavioral: Music TherapyParticipants in the experimental group will be given choices about how to proceed with the session: active or passive, improvisation, re-creative or receptive songs, or receptive (relaxation). Three music therapy sessions will be completed, the first within 24 hours of admission, the second 24-96 hours of session 1, and the final session the day before stem cell infusion. |
| No Music Therapy | Active comparator | Behavioral: No Music TherapyParticipants randomized to the standard care group will be asked to rate the same symptoms as those in the experimental group. This will mark the beginning of a 45-minute control condition period during which the participants may fill the 45-minute time-period in whatever ways they choose. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients undergoing inpatient allogeneic stem cell transplant
- Must be fluent in English
- Must be able to communicate verbally and have no significant hearing impairment
- Have capacity to provide consent
- All diagnosis, graft source, donor sources will be included.
Key exclusion criteria (1 listed)
- Patients not meeting the above inclusion criteria
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 |
|---|---|---|
| Music TherapyNo narcotic or anti-emetic therapy will be administered for at least 2 hours prior to music therapy session. Music therapy sessions will be administered by a board certified music therapist (MT-BC) and last approximately 45 minutes. Involvement in sessions will be based on therapist and patient availability. | Behavioural | Music Therapy |
| No Music TherapyParticipants will fill the same 45 minute period in any way they choose; however, they will be asked to refrain from listening to recorded music during this time. | Behavioural | No Music Therapy |
Primary outcome
Change in Distress Score
Time frame: From admission to day -1 (up to 9 days)
Distress Thermometer assessments for both the experimental and standard care group will be given in the mid-late afternoon. This is an analog scale from 0-10 where 0 indicates no distress and 10 indicates extreme distress.
8 secondary outcomes
Change in Pain Score
Time frame: Within 24 hours of admission
Change in Pain Score
Time frame: Up to 96 hours after session 1 (120 hours from admission)
Change in Pain Score
Time frame: Up to 24 hours before procedure
Change in Mood Score
Time frame: Within 24 hours of admission
Change in Mood Score
Time frame: Up to 96 hours after session 1 (120 hours from admission)
Change in Mood Score
Time frame: Up to 24 hours before procedure
Change in Quality of Life Score
Time frame: From admission to day -1 (up to 9 days)
Total Narcotic Medication Use
Time frame: From admission to day -1 (up to 9 days)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2019.
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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.
Navneet Majhail, MD principal investigator
Cleveland Clinic, Taussig Cancer Institute, Case Comprehensive Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Music Therapy and No Music Therapy in people with Hematopoietic Stem Cell Transplant, run by Case Comprehensive Cancer Center 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 1 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: finished, as of the sponsor's last update on 1 Aug 2019. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in Distress Score (time frame: From admission to day -1 (up to 9 days)). 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 1 Aug 2019.