Music Therapy and Hematopoietic Stem Cell Transplant

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).

Study Overview

• Status: Completed
• Conditions: Hematopoietic Stem Cell Transplant
• Intervention / Treatment: Behavioral: Music Therapy; Behavioral: No Music Therapy

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 Type: Interventional
• Enrollment (Actual): 56
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic, Taussig Cancer Institute, Case Comprehensive Cancer Center

Participation Criteria

Eligibility Criteria

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

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	From admission to day -1 (up to 9 days)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	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.	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.	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.	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.	From admission to day -1 (up to 9 days)

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): February 26, 2018
• Primary Completion (Actual): June 21, 2019
• Study Completion (Actual): June 21, 2019

Study Registration Dates

• First Submitted: December 15, 2017
• First Submitted That Met QC Criteria: December 15, 2017
• First Posted (Actual): December 19, 2017

Study Record Updates

• Last Update Posted (Actual): August 1, 2019
• Last Update Submitted That Met QC Criteria: July 31, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Keywords: Music Therapy
• Other Study ID Numbers: CASE16Z17

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No