An official website of the United States government
Government Funding Lapse Because of a lapse in government funding, the information on this website may not be up to date, transactions submitted via the website may not be processed, and the agency may not be able to respond to inquiries until appropriations are enacted.
The NIH Clinical Center (the research hospital of NIH) is open. For more details about its operating status, please visit cc.nih.gov.
Updates regarding government operating status and resumption of normal operations can be found at opm.gov.
A Music Therapy Study for Blood Cancer Survivors with Cognitive Difficulties, PRELUDE Trial
Trial Status: active
This clinical trial tests whether music therapy telehealth sessions, compared to music education sessions, improve cognitive function in patients with leukemia, lymphoma, or multiple myeloma. Cancer and treatments for cancer can cause problems with attention, memory, and/or learning. These cognitive difficulties may affect a patient's daily activities and can worsen their quality of life. The usual approach for patients with cognitive difficulties is treatment with medications or different forms of therapy, including cognitive rehabilitation. Music therapy (MT) is an evidence-based intervention in which board-certified music therapists guide patients through personalized experiences with music to achieve therapeutic goals. These experiences range from receptive activities, such as guided music listening, to more active forms of musical engagement, such playing an instrument. In this study, patients who receive the music therapy intervention will participate in therapeutic music lessons, guided music listening, and music-centered discussions. These music therapy sessions may be more effective than simple music education for improving cancer-related cognitive dysfunction in patients with leukemia, lymphoma, or multiple myeloma.
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 Perceived Cognitive Impairment (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., chimeric antigen receptor [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
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
Additional locations may be listed on ClinicalTrials.gov for NCT07052916.
Locations matching your search criteria
United States
New Jersey
Basking Ridge
Memorial Sloan Kettering Basking Ridge
Status: Active
Contact: Kevin Liou
Phone: 646-608-8563
Middletown
Memorial Sloan Kettering Monmouth
Status: Active
Contact: Kevin Liou
Phone: 646-608-8563
Montvale
Memorial Sloan Kettering Bergen
Status: Active
Contact: Kevin Liou
Phone: 646-608-8563
New York
Commack
Memorial Sloan Kettering Commack
Status: Active
Contact: Kevin Liou
Phone: 646-608-8563
New York
Memorial Sloan Kettering Cancer Center
Status: Active
Contact: Kevin Liou
Phone: 646-608-8563
Uniondale
Memorial Sloan Kettering Nassau
Status: Active
Contact: Kevin Liou
Phone: 646-608-8563
West Harrison
Memorial Sloan Kettering Westchester
Status: Active
Contact: Kevin Liou
Phone: 646-608-8563
PRIMARY OBJECTIVE:
I. To determine the feasibility of studying a telehealth-based music therapy (MT) intervention for cancer-related cognitive dysfunction (CRCD) in hematologic cancer survivors.
SECONDARY OBJECTIVE:
I. To explore the preliminary effects of a telehealth-based MT intervention, as well as its therapist attention-music education (TAME) and wait-list control (WLC) comparators, on CRCD and co-morbid symptoms.
TERTIARY OBJECTIVES:
I. Will explore:
Ia. Associations between co-morbid symptoms (Hospital Anxiety and Depression Scale [HADS], Brief Fatigue Inventory [BFI]) and CRCD (Functional Assessment of Cancer Therapy-Cognitive Function [FACT-Cog], Hopkins Verbal Learning Test Revised [HVLT-R], Attention Network Task [ANT]);
Ib. Improvement in objective attention (HVLT-R Trial 1, ANT variables) as a predictor of treatment response (≥ FACT-Cog minimum clinically important difference [MCID] value).
OUTLINE: Patients are randomized to 1 of 3 arms.
ARM I: Patients attend MT telehealth sessions including therapeutic music lessons, guided music listening, and music-centered discussions over 60 minutes each weekly for 12 sessions. Between sessions, patients practice music skills and complete music exploration sessions in the Playground Sessions application for at least 10 minutes daily.
ARM II: Patients attend TAME sessions including music listening exercises over 60 minutes each weekly for 12 sessions. Between sessions, patients listen to suggested songs in the designated genre for at least 10 minutes daily.
ARM III: Patients receive usual care for 12 weeks. Patients may choose to receive the MT or TAME intervention after follow-up period (at week 24).
After completion of study intervention, patients are followed up at weeks 18 and 24.
Trial PhaseNo phase specified
Trial Typetreatment
Lead OrganizationMemorial Sloan Kettering Cancer Center