NCT05215353 A Study Comparing Music Therapy and Cognitive Behavioral Therapy for Anxiety in Cancer Survivors
| NCT ID | NCT05215353 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Memorial Sloan Kettering Cancer Center |
| Condition | Survivorship |
| Study Type | INTERVENTIONAL |
| Enrollment | 368 participants |
| Start Date | 2022-01-14 |
| Primary Completion | 2027-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 368 participants in total. It began in 2022-01-14 with a primary completion date of 2027-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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
Contact & Investigator
Jun Mao, MD, MSCE
PRINCIPAL INVESTIGATOR
Memorial Sloan Kettering Cancer Center
Frequently Asked Questions
Who can join the NCT05215353 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Survivorship. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05215353 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT05215353 currently recruiting?
Yes, NCT05215353 is actively recruiting participants. Contact the research team at maoj@mskcc.org for enrollment information.
Where is the NCT05215353 trial being conducted?
This trial is being conducted at Miami, United States, New York, United States, Philadelphia, United States.
Who is sponsoring the NCT05215353 clinical trial?
NCT05215353 is sponsored by Memorial Sloan Kettering Cancer Center. The principal investigator is Jun Mao, MD, MSCE at Memorial Sloan Kettering Cancer Center. The trial plans to enroll 368 participants.