Music Therapy and Hematopoietic Stem Cell Transplant

• ClinicalTrials.gov Identifier: NCT03378089
• Recruitment Status: Completed
• First Posted: December 19, 2017
• Last Update Posted: August 1, 2019
• Sponsor: Case Comprehensive Cancer Center
• Information provided by (Responsible Party): Case Comprehensive Cancer Center

Study Description

Brief 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).

Condition or disease	Intervention/treatment	Phase
Hematopoietic Stem Cell Transplant	Behavioral: Music Therapy; Behavioral: No Music Therapy	Not Applicable

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

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 56 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Official Title: The Effects of Pre-Transplant Music Therapy for Patients Undergoing Hematopoietic Stem Cell Transplant
• Actual Study Start Date: February 26, 2018
• Actual Primary Completion Date: June 21, 2019
• Actual Study Completion Date: June 21, 2019

Arms and Interventions

Arm	Intervention/treatment
Experimental: 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.	Behavioral: 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.
Active Comparator: 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.	Behavioral: 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.

Outcome Measures

Primary Outcome Measures :

1. 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.

Secondary Outcome Measures :

1. Change in Pain Score [ Time Frame: Within 24 hours of admission ]
   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.
2. Change in Pain Score [ Time Frame: Up to 96 hours after session 1 (120 hours from admission) ]
   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.
3. Change in Pain Score [ Time Frame: Up to 24 hours before procedure ]
   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.
4. Change in Mood Score [ Time Frame: Within 24 hours of admission ]
   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.
5. Change in Mood Score [ Time Frame: Up to 96 hours after session 1 (120 hours from admission) ]
   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.
6. Change in Mood Score [ Time Frame: Up to 24 hours before procedure ]
   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.
7. Change in Quality of Life Score [ Time Frame: From admission to day -1 (up to 9 days) ]
   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.
8. Total Narcotic Medication Use [ Time Frame: From admission to day -1 (up to 9 days) ]
   Medication will be extracted from the electronic medical record and converted to morphine equivalent doses.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• 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.

Exclusion Criteria:

• Patients not meeting the above inclusion criteria

Contacts and Locations

Locations

United States, Ohio

Cleveland Clinic, Taussig Cancer Institute, Case Comprehensive Cancer Center

Cleveland, Ohio, United States, 44195

Sponsors and Collaborators

Case Comprehensive Cancer Center

Investigators

• Principal Investigator: Navneet Majhail, MD; Cleveland Clinic, Taussig Cancer Institute, Case Comprehensive Cancer Center

More Information

• Responsible Party: Case Comprehensive Cancer Center
• ClinicalTrials.gov Identifier: NCT03378089
• Other Study ID Numbers: CASE16Z17
• First Posted: December 19, 2017
• Last Update Posted: August 1, 2019
• Last Verified: July 2019

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Case Comprehensive Cancer Center:

Music Therapy