A Study of the Experience of Music Therapy in Cancer Patients With Delirium

August 21, 2023 updated by: Memorial Sloan Kettering Cancer Center

Music Therapy With Oncology Patients and Delirium: An Exploratory Study

The purpose of this study is to improve our understanding of the experience of music therapy by cancer patients with delirium, and the experience of music therapists working with these patients. The researchers are focusing on patients with delirium because of the challenging symptoms of this condition.

At MSK, music therapy is routinely used in patients with cancer. Music therapy sessions are done at the patient's bedside, where the music therapist plays live music on a guitar, keyboard, harp, or percussion instrument, sometimes as accompaniment to singing.

Study Overview

Study Type

Observational

Enrollment (Actual)

17

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • New York
      • New York, New York, United States, 10065
        • Memorial Sloan Kettering Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patient subjects who are referred for music therapy will be identified to the researcher by a board-certified music therapist on staff at MSKCC (excluding the Principal Investigator).

Description

Inclusion Criteria:

  • adult patients (ages 18-75) with delirium
  • referred for and receive music therapy.
  • were identified as having delirium by the Confusion Assessment Method (CAM), Confusion Assessment Method for ICU patients (CAM-ICU) or a documented diagnosis by a clinician from the Department of Psychiatry and Behavioral Sciences in the patient's electronic medical record (EMR).
  • Patients that have had music therapy in the past will be eligible for the study
  • Only patients that recover from delirium (per CAM, CAM-ICU, or progress note by a clinician from the Department of Psychiatry and Behavioral Sciences) after receiving music therapy will be approached for interview by the researcher.

This study will also include their caregivers, music therapists, primary nurse, and bedside companions who have participated in or observed the participants' response to music therapy.

The music therapist participants are:

  • Board-certified senior music therapists with 10 or more years experience in the research site who sign a blanket consent form to participate in study.
  • Assigned to eligible patients by Integrative Medicine Service Client Service Representative (CSR).

The caregivers are:

  • Family or unrelated adult (>18) caregivers who observed bedside music therapy session(s) with patients meeting inclusion criteria

The staff caregivers are:

  • Primary nurse caring for eligible patients who receive their first music therapy session while experiencing delirium.
  • Patient care technicians (PCT) assigned as bedside companions for eligible patients who receive music therapy

Exclusion Criteria:

  • have a known hearing impairment
  • do not speak English.
  • are heavily sedated, comatose, or expected to be discharged or expire within 48 hours
  • have known comorbidities of delirium tremens, steroid psychosis, or dementia

Caregivers will be excluded from the study if they do not speak English. Music therapists, nurses, or bedside companions will be excluded if they are not assigned to eligible patients.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
patients
Participate in 30-60 minute interviews after each music therapy session.
Music therapy sessions may last 20-60 minutes, with length and frequency to be determined mutually (generally 1-3 times per week). Music therapy sessions are done at the patient's bedside, where the music therapist plays live music on a guitar, keyboard, harp, or percussion instrument, sometimes as accompaniment to singing.
Each interview will be conducted in person in a private setting (with the exception of caregivers, who have the option to conduct interviews over the phone if it is not feasible to take place in the hospital). Each interview will follow a semi-structured interview guide and will ask for consent to audio record the interviews .
caregivers
Participate in 30-60 minute interviews after each music therapy session (ideally within 3 days).
Music therapy sessions may last 20-60 minutes, with length and frequency to be determined mutually (generally 1-3 times per week). Music therapy sessions are done at the patient's bedside, where the music therapist plays live music on a guitar, keyboard, harp, or percussion instrument, sometimes as accompaniment to singing.
Each interview will be conducted in person in a private setting (with the exception of caregivers, who have the option to conduct interviews over the phone if it is not feasible to take place in the hospital). Each interview will follow a semi-structured interview guide and will ask for consent to audio record the interviews .
nurses
Participate in 10-15 minute interviews after initial music therapy session.
Music therapy sessions may last 20-60 minutes, with length and frequency to be determined mutually (generally 1-3 times per week). Music therapy sessions are done at the patient's bedside, where the music therapist plays live music on a guitar, keyboard, harp, or percussion instrument, sometimes as accompaniment to singing.
Each interview will be conducted in person in a private setting (with the exception of caregivers, who have the option to conduct interviews over the phone if it is not feasible to take place in the hospital). Each interview will follow a semi-structured interview guide and will ask for consent to audio record the interviews .
music therapists
Music therapist will notify the researcher if he/she has provided music therapy for a patient who is identified as having delirium. Music therapists will also be interviewed about the clinical process after initial and follow up music sessions.
Each interview will be conducted in person in a private setting (with the exception of caregivers, who have the option to conduct interviews over the phone if it is not feasible to take place in the hospital). Each interview will follow a semi-structured interview guide and will ask for consent to audio record the interviews .

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
thematic analysis of data with music therapists
Time Frame: 1 year
by interviews
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
thematic analysis of data with caregivers, nurses, and patients
Time Frame: 1 year
by interviews
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Collaborators

Investigators

  • Principal Investigator: Holly Mentzer, MA, LCAT, MT-BC, Memorial Sloan Kettering Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 23, 2019

Primary Completion (Actual)

August 18, 2023

Study Completion (Actual)

August 18, 2023

Study Registration Dates

First Submitted

September 24, 2019

First Submitted That Met QC Criteria

September 24, 2019

First Posted (Actual)

September 26, 2019

Study Record Updates

Last Update Posted (Actual)

August 22, 2023

Last Update Submitted That Met QC Criteria

August 21, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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