Clinical trial NCT03378089: Music Therapy and Hematopoietic Stem Cell Transplant
Official title: The Effects of Pre-Transplant Music Therapy for Patients Undergoing Hematopoietic Stem Cell Transplant
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hematopoietic Stem Cell Transplant
Keywords: Music Therapy
Lead sponsor: Case Comprehensive Cancer Center
Sponsor class: OTHER
First posted: 2017-12-19
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility 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

Primary outcomes:
measure: Change in Distress Score
timeFrame: From admission to day -1 (up to 9 days)
Secondary outcomes:
measure: Change in Pain Score
timeFrame: Within 24 hours of admission
measure: Change in Pain Score
timeFrame: Up to 96 hours after session 1 (120 hours from admission)
measure: Change in Pain Score
timeFrame: Up to 24 hours before procedure
measure: Change in Mood Score
timeFrame: Within 24 hours of admission
measure: Change in Mood Score
timeFrame: Up to 96 hours after session 1 (120 hours from admission)
measure: Change in Mood Score
timeFrame: Up to 24 hours before procedure
measure: Change in Quality of Life Score
timeFrame: From admission to day -1 (up to 9 days)
measure: Total Narcotic Medication Use
timeFrame: From admission to day -1 (up to 9 days)
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Cleveland Clinic, Taussig Cancer Institute, Case Comprehensive Cancer Center
state: Ohio
Study officials:
affiliation: Cleveland Clinic, Taussig Cancer Institute, Case Comprehensive Cancer Center
name: Navneet Majhail, MD
role: PRINCIPAL_INVESTIGATOR
References: