Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
56 participants
INTERVENTIONAL
2018-02-26
2019-06-21
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Music Therapy
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.
Music Therapy
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 Therapy
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.
No Music Therapy
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.
Interventions
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Music Therapy
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 Therapy
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.
Eligibility Criteria
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Inclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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Case Comprehensive Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Navneet Majhail, MD
Role: PRINCIPAL_INVESTIGATOR
Cleveland Clinic, Taussig Cancer Institute, Case Comprehensive Cancer Center
Locations
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Cleveland Clinic, Taussig Cancer Institute, Case Comprehensive Cancer Center
Cleveland, Ohio, United States
Countries
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Other Identifiers
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CASE16Z17
Identifier Type: -
Identifier Source: org_study_id
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