Music Therapy and Hematopoietic Stem Cell Transplant

Case Comprehensive Cancer Center (Case CCC)

Status: Completed

Conditions: Hematopoietic Stem Cell Transplant

Treatments: Behavioral: Music Therapy; Behavioral: No Music Therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT03378089

CASE16Z17

Details and patient eligibility

About

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).

Full 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.

Enrollment: 56 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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56 participants in 2 patient groups

Music Therapy

Experimental group

Description:

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.

Treatment:

Behavioral: Music Therapy

No Music Therapy

Active Comparator group

Description:

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.

Treatment:

Behavioral: No Music Therapy