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)
1 other identifier
interventional
60
1 country
7
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jun 2025
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 27, 2025
CompletedFirst Submitted
Initial submission to the registry
June 30, 2025
CompletedFirst Posted
Study publicly available on registry
July 8, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 27, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 27, 2026
July 11, 2025
June 1, 2025
1.5 years
June 30, 2025
July 9, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
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
Study Arms (3)
Music Therapy/MT
EXPERIMENTALParticipants 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
Therapist Attention-Music Education/TAME control
ACTIVE COMPARATORPatients 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.
Wait-List Control/WLC
NO INTERVENTIONThe 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.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (7)
Memorial Sloan Kettering Basking Ridge (All protocol activities)
Basking Ridge, New Jersey, 07920, United States
Memorial Sloan Kettering Monmouth (All protocol activities)
Middletown, New Jersey, 07748, United States
Memorial Sloan Kettering Bergen (All protocol activities)
Montvale, New Jersey, 07645, United States
Memorial Sloan Kettering Cancer Center Suffolk - Commack (All protocol activities)
Commack, New York, 11725, United States
Memorial Sloan Kettering Westchester (All protocol activities)
Harrison, New York, 10604, United States
Memorial Sloan Kettering Cancer Center (All protocol activities)
New York, New York, 10065, United States
Memorial Sloan Kettering Nassau (All protocol activities)
Uniondale, New York, 11553, United States
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Kevin Liou, MD
Memorial Sloan Kettering Cancer Center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 30, 2025
First Posted
July 8, 2025
Study Start
June 27, 2025
Primary Completion (Estimated)
December 27, 2026
Study Completion (Estimated)
December 27, 2026
Last Updated
July 11, 2025
Record last verified: 2025-06
Data Sharing
- IPD Sharing
- Will share
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.