Music Therapy and Hematopoietic Stem Cell Transplant

Hematopoietic Stem Cell Transplant Clinical Trial

Official title:

The Effects of Pre-Transplant Music Therapy for Patients Undergoing Hematopoietic Stem Cell Transplant

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03378089
• Other study ID #: CASE16Z17
• Status: Completed
• Phase: N/A
• Start date: February 26, 2018
• Est. completion date: June 21, 2019

Study information

• Verified date: July 2019
• Source: Case Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: June 21, 2019
• Est. primary completion date: June 21, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hematopoietic Stem Cell Transplant

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Cleveland Clinic, Taussig Cancer Institute, Case Comprehensive Cancer Center	Cleveland	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Case Comprehensive Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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)
Secondary	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
Secondary	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
Secondary	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)
Secondary	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
Secondary	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)
Secondary	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)