Cancer Patients With DeliriumNCT04104217
A Study of the Experience of Music Therapy in Cancer Patients With Delirium
An observational study of Cancer Patients With Delirium, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Cancer Patients With Delirium
- What is being tested?
- Music therapy and Interviews
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Sep 2019to 18 Aug 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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).
Who may be able to join
- 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.
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- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
About this study
Official title: 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.
- Conditions
- Cancer Patients With Delirium
- Being tested
- Music therapy, Interviews
- Keywords
- Music therapy, 19-270
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Music therapyBehavioural
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.
InterviewsBehavioural
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 .
| Study group | Role | What they receive |
|---|---|---|
| patients | Participate in 30-60 minute interviews after each music therapy session. Receives: Behavioral: Music therapy; Behavioral: Interviews | |
| caregivers | Participate in 30-60 minute interviews after each music therapy session (ideally within 3 days). Receives: Behavioral: Music therapy; Behavioral: Interviews | |
| nurses | Participate in 10-15 minute interviews after initial music therapy session. Receives: Behavioral: Music therapy; Behavioral: 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. Receives: Behavioral: Interviews |
What is being measured
The primary outcome is the main question the study is designed to answer.
thematic analysis of data with music therapists
by interviews
Measured: 1 year
Secondary outcomes (1)
thematic analysis of data with caregivers, nurses, and patients
by interviews
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2019
- Study start23 Sep 2019
- Primary completion18 Aug 2023
- Study completion18 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer Patients With DeliriumStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- New York University
- Responsible party
- Sponsor
- Investigators
- Holly Mentzer, MA, LCAT, MT-BC, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04104217
- Sponsor's protocol ID
- 19-270
- Status last verified
- Aug 2023
- First submitted
- 24 Sep 2019
- Last updated
- 22 Aug 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Music Therapy With Oncology Patients and Delirium: An Exploratory Study
- ClinicalTrials.gov ID
- NCT04104217
- Acronym / sponsor ID
- 19-270
- Conditions
- Cancer Patients With Delirium
- Keywords
- Music therapy, 19-270
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Collaborators
- New York University
- Study start
- 23 Sep 2019 (actual)
- Primary completion
- 18 Aug 2023 (actual)
- Study completion
- 18 Aug 2023 (actual)
- First posted
- 26 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| patients | – | Behavioral: Music therapy, Behavioral: InterviewsParticipate in 30-60 minute interviews after each music therapy session. |
| caregivers | – | Behavioral: Music therapy, Behavioral: InterviewsParticipate in 30-60 minute interviews after each music therapy session (ideally within 3 days). |
| nurses | – | Behavioral: Music therapy, Behavioral: InterviewsParticipate in 10-15 minute interviews after initial music therapy session. |
| music therapists | – | Behavioral: InterviewsMusic 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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).
Key inclusion criteria (14 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Music therapyMusic 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. | Behavioural | caregivers, nurses, patients |
| InterviewsEach 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 . | Behavioural | caregivers, music therapists, nurses, patients |
Primary outcome
thematic analysis of data with music therapists
Time frame: 1 year
by interviews
1 secondary outcome
thematic analysis of data with caregivers, nurses, and patients
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2023.
- Memorial Sloan Kettering Cancer CenterLink provided by the sponsor.
Related trials for Cancer Patients With Delirium
RecruitingObservational study
Immunonutrition and Neuromonitoring for Postoperative Delirium in Gynecologic Oncology
Postoperative Delirium (POD), Gynecologic Cancers
Active, not recruitingPhase 2/3
Haloperidol With or Without Chlorpromazine in Treating Delirium in Patients With Advanced, Metastatic, or Recurrent Cancer
Advanced Malignant Neoplasm, Delirium
Not yet recruitingObservational study
A Study for Postoperative Delirium in Older Patients With Intracranial Tumors
Delirium, Brain Tumor
Active, not recruitingPhase 2
Haloperidol and Lorazepam for Delirium in Patients With Advanced Cancer
Advanced Cancers
Active, not recruitingPhase 2/3
Haloperidol and Lorazepam in Controlling Symptoms of Persistent Agitated Delirium in Patients With Advanced Cancer Undergoing Palliative Care
Delirium, Locally Advanced Malignant Neoplasm
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Holly Mentzer, MA, LCAT, MT-BC principal investigator
Memorial Sloan Kettering Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer Patients With Delirium, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
thematic analysis of data with music therapists (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2023.