A Music Therapy Study for Blood Cancer Survivors With Cognitive Difficulties

Pilot Trial of Telehealth Music Therapy for Cognitive Dysfunction in Hematologic Cancer Survivors (PRELUDE)

Research has shown that music-based activities may help improve brain functions, such as attention, memory, and executive function. Because of this past research, the researchers are doing this study to find out whether telehealth music therapy is a practical treatment for cognitive difficulties in blood cancer survivors. The researchers will also study whether music therapy and music education help improve cognitive function and other common symptoms such as anxiety, depression, and/or tiredness.

Study Overview

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

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

Study Contact

  • Name: Jun Mao, MD, MSCE
  • Phone Number: 646-608-8552
  • Email: maoj@mskcc.org

Study Contact Backup

Study Locations

    • New Jersey
      • Basking Ridge, New Jersey, United States, 07920
        • Recruiting
        • Memorial Sloan Kettering Basking Ridge (All Protocol Activities)
        • Contact:
          • Kevin Liou, MD
          • Phone Number: 646-608-8559
      • Middletown, New Jersey, United States, 07748
        • Recruiting
        • Memorial Sloan Kettering Monmouth (All protocol activities)
        • Contact:
          • Kevin Liou, MD
          • Phone Number: 646-608-8559
      • Montvale, New Jersey, United States, 07645
        • Recruiting
        • Memorial Sloan Kettering Bergen (All Protocol Activities)
        • Contact:
          • Kevin Liou, MD
          • Phone Number: 646-608-8559
    • New York
      • Commack, New York, United States, 11725
        • Recruiting
        • Memorial Sloan Kettering Cancer Center Suffolk - Commack (All protocol activities)
        • Contact:
          • Kevin Liou, MD
          • Phone Number: 646-608-8559
      • Harrison, New York, United States, 10604
        • Recruiting
        • Memorial Sloan Kettering Westchester (All Protocol Activities)
        • Contact:
          • Kevin Liou, MD
          • Phone Number: 646-608-8559
      • New York, New York, United States, 10065
        • Recruiting
        • Memorial Sloan Kettering Cancer Center (All Protocol Activities)
        • Contact:
          • Kevin Liou, MD
          • Phone Number: 646-608-8563
      • Uniondale, New York, United States, 11553
        • Recruiting
        • Memorial Sloan Kettering Nassau (All Protocol Activities)
        • Contact:
          • Kevin Liou, MD
          • Phone Number: 646-608-8559

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • English-proficient, aged 18 or older
  • Diagnosis of lymphoma, leukemia, or myeloma
  • Stable oncologic disease or no evidence of disease as indicated in the medical chart or by the oncology team
  • Score of <54 on the FACT-Cog PCI subscale
  • Minimum life expectancy of one year as per clinician assessment
  • Patient should be able to understand and complete all study assessments on their own.
  • Eligible patient should be able to understand informed consent and provide signed informed consent in English.

Exclusion Criteria:

  • Less than 3 months since completion of surgery, radiation, induction chemotherapy (for newly diagnosed or relapsed disease), transplantation, or immunotherapy (e.g., CAR T-Cell, bispecific antibodies)

    • If there is a defined treatment period, the patient must be at least 3 months from treatment completion
    • If the patient is on continuous therapy, patient must have completed at least 6 months of the therapy
    • Maintenance therapies are allowed
  • Received music therapy (MT) in the past year
  • Current music training, >6 months of music training in the past 10 years, or plan to initiate music training during the study
  • No access to an internet-connected device
  • Active suicidal ideation, bipolar, schizophrenia, or substance abuse
  • BOMC score ≥10 (indicative of dementia)
  • Uncorrectable visual, auditory, or motor impairments
  • Initiation or altered dose of sedative, stimulant, or anti-cholinergic medications in the past month or plan to initiate these medications during the study, as these are known to impact cognitive function
  • Initiation of any other interventions for CRCD (e.g., cognitive rehabilitation) in the past month or plan to initiate these interventions during the study, as these are known to impact cognitive function

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

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Music Therapy/MT
Participants will receive 12, weekly 60-minute MT sessions (+/- 1 week) with homework in-between sessions to reinforce in-session concepts, practice musical skills, and serve as transitions to subsequent sessions
Therapeutic music lessons are the core component of the Music Therapy/MT intervention. Other components include guided music listening to help participants use music as a tool for regulating mood, energy, and attention, as well as music-centered discussions to help participants discover songs with personal meaning that they will enjoy learning to play.
Active Comparator: Therapist Attention-Music Education/TAME control
Patients will receive 12, weekly 60-minute Therapist Attention-Music Education/TAME sessions (+/- 1 week) with homework in-between sessions to reinforce in-session concepts and serve as transitions to subsequent sessions. The TAME control group will involve board-certified music therapists guiding participants through music listening exercises.
Participants will receive 12, weekly 60-minute TAME sessions (+/- 1 week) with homework in-between sessions to reinforce in-session concepts and serve as transitions to subsequent sessions. The TAME control group will involve board-certified music therapists guiding participants through music listening exercises.
No Intervention: Wait-List Control/WLC
The Wait-List Control/WLC group will receive usual care from healthcare providers and complete the same assessments as the other groups. The WLC will have the option of receiving either 12 sessions of MT or 12 sessions of TAME intervention when the study concludes after the 24-week waiting period. The WLC participants will choose which intervention (MT or TAME) they wish to receive.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Feasibility of studying a telehealth-based Music Therapy/MT intervention for cancer-related cognitive dysfunction/CRCD in hematologic cancer survivors as defined as the completion of 9 or more sessions.
Time Frame: up to 1 year
The primary objective of this study is to determine the feasibility of studying a telehealth-based Music Therapy/MT intervention for cancer-related cognitive dysfunction/CRCD in hematologic cancer survivors. Feasibility will be defined as the completion of 9 or more sessions out of the planned 12 weekly sessions of music therapy.
up to 1 year

Collaborators and Investigators

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

Investigators

  • Principal Investigator: Kevin Liou, MD, 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)

June 27, 2025

Primary Completion (Estimated)

December 27, 2026

Study Completion (Estimated)

December 27, 2026

Study Registration Dates

First Submitted

June 30, 2025

First Submitted That Met QC Criteria

June 30, 2025

First Posted (Actual)

July 8, 2025

Study Record Updates

Last Update Posted (Actual)

May 26, 2026

Last Update Submitted That Met QC Criteria

May 22, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.

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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