A Study Comparing Music Therapy and Cognitive Behavioral Therapy for Anxiety in Cancer Survivors

Официальное название

Music Therapy vs. Cognitive-Behavioral Therapy for Cancer-related Anxiety (MELODY)

Обзор

The researchers are doing this study to compare how music therapy and cognitive behavioral therapy, given virtually, may be able to reduce anxiety in people who have had cancer. In addition, this study will see if certain factors affect how well participants respond to music therapy or cognitive behavioral therapy. For example, the researchers will see if personal characteristics (like age, sex, race, and education) and ways of thinking (like expectations of therapy) may affect how well participants respond.

Вмешательства

• Другое Music Therapy
  Participants will receive seven weekly 60-minute treatments of music therapy. All sessions will be delivered virtually through Zoom.
• Другое Cognitive Behavioral Therapy
  Participants will receive seven weekly 60-minute treatment of cognitive behavioral therapy. All sessions will be delivered virtually through Zoom.
• Другое assessments
  Participants will complete study assessments prior to randomization (week 0) and at weeks 4, 8, 16, and 26. A subgroup of 60 survivors will complete optional semi-structured interviews after treatment to understand their unique experiences with MT or CBT. All participants will be followed for 26 weeks.

Первичные конечные точки

• HADS anxiety score changes [Срок оценки: 8 weeks]
• HADS anxiety score changes [Срок оценки: 26 weeks]

Критерии участия

Критерии включения

• English- or Spanish-speaking
• 18 years or older
• Prior cancer diagnosis of any type or stage
• Free of oncological disease, or stable disease with no evidence of progression
• Score of ≥8 on the anxiety subscale of the Hospital Anxiety and Depression Scale (HADS)
• Report anxiety symptoms lasting at least one month
• Willing to adhere to all study-related procedures, including randomization to one of two treatment arms: MT or CBT
• Access to Zoom and a quiet/private location

Inclusion Criteria for Advanced Cancer Sub-Study (N=50)

• English-speaking
• 18 years or older
• Advanced cancer diagnosis: stage III or IV lung cancer; any stage pancreatic cancer, unresectable cholangiocarcinoma, unresectable liver cancer, unresectable ampullary or peri-ampullary cancer, or other stage IV gastrointestinal cancer; stage III or IV ovarian or fallopian tube cancers or other stage IV gynecologic cancer; stage IV breast cancer; stage III testicular cancer or any stage IV genitourinary cancer; stage IV sarcoma; stage IV melanoma; stage IV endocrine cancer; lymphoma, myeloma, or leukemia
• Currently receiving oncological treatment or on active surveillance
• Karnofsky performance score of ≥60
• Score of ≥8 on the HADS anxiety subscale
• Anxiety symptoms lasting for at least 1 month
• Greater than 6-month expected survival as judged by the treating oncologist
• Willing to adhere to all study procedures
• Access to Zoom and a quiet/private location

Inclusion Criteria for group MT sub-study (N=18)

• English-speaking
• 18 years or older
• Prior cancer diagnosis of any type or stage
• Free of oncological disease, or stable disease with no evidence of progression
• Score of ≥8 on the anxiety subscale of the Hospital Anxiety and Depression Scale (HADS)
• Report anxiety symptoms lasting at least one month
• Willing to adhere to all study-related procedures
• Access to Zoom and a quiet/private location

Критерии исключения

• Completed active cancer treatment (e.g., surgery, radiation, chemotherapy) less than one month prior to enrollment (maintenance hormonal or targeted therapies are allowed).
• Active suicidal ideation, bipolar disorder, schizophrenia, or substance abuse
• Score of ≥10 indicative of cognitive impairment on the Blessed Orientation-Memory-Concentration
• Received a treatment course of seven or greater MT or CBT sessions for anxiety symptoms within the last six months
• Unable to provide informed consent for themselves

Exclusion Criteria for Advanced Cancer Sub-Study

• Active suicidal ideation; bipolar disorder, schizophrenia, or substance abuse
• Score of ≥10 on Blessed Orientation-Memory-Concentration
• Prior receipt of MT within the past six months
• Plan to receive any form of psychotherapy in the coming 8 weeks
• Initiation or change in anxiety medications within the past 4 weeks
• Plan to initiate or change anxiety medications in the coming 8 weeks
• Unable to provide informed consent for themselves

Exclusion Criteria for group MT sub-study

• Completed active cancer treatment (e.g., surgery, radiation, chemotherapy) less than one month prior to enrollment (maintenance hormonal or targeted therapies are allowed).
• Active suicidal ideation; bipolar disorder, schizophrenia, or substance abuse
• Score of ≥10 on Blessed Orientation-Memory-Concentration
• Prior receipt of MT within the past six months
• Plan to receive any form of psychotherapy in the coming 8 weeks
• Initiation or change in anxiety medications within the past 4 weeks
• Unable to provide informed consent for themselves

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

США · 3 центра

• Baptist Alliance MCI — Miami
• Memorial Sloan Kettering Cancer Center — New York
• Drexel University — Philadelphia

Публикации

• Liou KT, Bradt J, Currier MB, Baser R, Panageas K, MacLeod J, Walker D, Li SQ, Lopez AM, McConnell K, Mao JJ. Music Therapy Versus Cognitive Behavioral Therapy via Telehealth for Anxiety in Survivors of Cancer: A Randomized Clinical Trial. J Clin Oncol. 2026 Feb 10;44(5):375-385. doi: 10.1200/JCO-25-00726. Epub 2026 Jan 6. PMID 41494146

Идентификаторы

NCT: NCT05215353 · 21-516

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗