Music Therapy and Hematopoietic Stem Cell Transplant

Not Applicable

Completed

• Conditions: Hematopoietic Stem Cell Transplant
• Interventions: Behavioral: Music Therapy; Behavioral: No Music Therapy

• Registration Number: NCT03378089
• Lead Sponsor: Case Comprehensive Cancer Center

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).

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 Timeline

• Study First Submitted: 2017-12-15
• Study First Submitted QC: 2017-12-15
• Study First Posted: 2017-12-19
• Study Start: 2018-02-26
• Primary Completion: 2019-06-21
• Study Completion: 2019-06-21
• Status Verified: 2019-07
• Last Update Submitted: 2019-07-31
• Last Update Posted: 2019-08-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 56

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Music Therapy	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.
No Music Therapy	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.

Primary Outcome Measures

Name	Time	Method
Change in Distress Score	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

Name	Time	Method
Change in Pain Score	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.
Change in Mood Score	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.
Change in Quality of Life Score	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.
Total Narcotic Medication Use	From admission to day -1 (up to 9 days)	Medication will be extracted from the electronic medical record and converted to morphine equivalent doses.

Trial Locations

Locations (1)

Cleveland Clinic, Taussig Cancer Institute, Case Comprehensive Cancer Center; 🇺🇸 Cleveland, Ohio, United States