A Music Therapy Study for Blood Cancer Survivors With Cognitive Difficulties

Официальное название

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

Обзор

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.

Вмешательства

• Другое 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.
• Другое 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.

Первичные конечные точки

• 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. [Срок оценки: up to 1 year]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 7 центров

• 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

Идентификаторы

NCT: NCT07052916 · 25-119

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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