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Recruiting NCT07052916

A Music Therapy Study for Blood Cancer Survivors With Cognitive Difficulties

No phase Interventional Blood Cancer Lymphoma Leukemia Myeloma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Music Therapy/MT, Therapist-Attention Music Education/TAME Control.
Who it may be relevant to
Registry conditions: Blood Cancer, Lymphoma, Leukemia, Myeloma. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Interventions

  • Other Music Therapy/MT
    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.
  • Other Therapist-Attention Music Education/TAME Control
    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.

Primary outcome measures

  • 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]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 7 centers
  • Memorial Sloan Kettering Basking Ridge (All protocol activities) — Basking Ridge
  • Memorial Sloan Kettering Monmouth (All protocol activities) — Middletown
  • Memorial Sloan Kettering Bergen (All protocol activities) — Montvale
  • Memorial Sloan Kettering Cancer Center Suffolk - Commack (All protocol activities) — Commack
  • Memorial Sloan Kettering Westchester (All protocol activities) — Harrison
  • Memorial Sloan Kettering Cancer Center (All protocol activities) — New York
  • Memorial Sloan Kettering Nassau (All protocol activities) — Uniondale

Identifiers

NCT: NCT07052916 · 25-119

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗