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Music Therapy vs Cognitive Behavioral Therapy for Anxiety in Cancer Survivors
Phase 4
Recruiting
Led By Jun Mao, MD, MSCE
Research Sponsored by Memorial Sloan Kettering Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Prior cancer diagnosis of any type or stage
18 years or older
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 26 weeks
Awards & highlights
Study Summary
This trial will compare the effects of music therapy and cognitive behavioral therapy on anxiety in cancer patients, as well as investigate possible moderators of treatment response.
Who is the study for?
This trial is for English or Spanish-speaking adults who have had any type of cancer, are now free from the disease, and experience anxiety (scoring ≥8 on HADS). They must be willing to try music therapy or cognitive behavioral therapy virtually and have access to Zoom. Those with recent active cancer treatment, severe cognitive impairment, extensive prior MT/CBT treatment for anxiety, or certain psychiatric conditions cannot join.Check my eligibility
What is being tested?
The study aims to compare virtual music therapy (MT) with cognitive behavioral therapy (CBT) in reducing anxiety among cancer survivors. It will also explore if personal traits like age and mindset influence how well patients respond to these therapies. Participants will be randomly assigned to either MT or CBT.See study design
What are the potential side effects?
Since this trial involves non-invasive therapies like Music Therapy and Cognitive Behavioral Therapy given virtually, significant side effects are not expected. However, participants may experience emotional discomfort during sessions.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with cancer before, regardless of the type or stage.
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I am 18 years old or older.
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I scored 8 or higher for anxiety on a medical questionnaire.
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My cancer is either gone or not getting worse.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 26 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~26 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
HADS anxiety score changes
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Music Therapy (MT)Experimental Treatment2 Interventions
MT is a non-pharmacological, evidence-based intervention, in which board-certified music therapists engage patients in personally tailored experiences with music to achieve therapeutic goals. Patients will receive a workbook with materials for each session These experiences range from music-guided relaxation to more active forms of musical engagement, including singing and improvising music.
Group II: Cognitive Behavioral Therapy (CBT)Active Control2 Interventions
Cognitive behavioral therapy (CBT) is an evidence-based, nonpharmacological intervention delivered by licensed mental health providers. Informed by the cognitive behavior model of anxiety, CBT focuses on the relationship between thoughts, behaviors, and emotions and how thoughts and behaviors can exacerbate or reduce anxiety.
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Who is running the clinical trial?
Memorial Sloan Kettering Cancer CenterLead Sponsor
1,936 Previous Clinical Trials
588,568 Total Patients Enrolled
Patient-Centered Outcomes Research InstituteOTHER
551 Previous Clinical Trials
29,997,128 Total Patients Enrolled
Jun Mao, MD, MSCEPrincipal InvestigatorMemorial Sloan Kettering Cancer Center
9 Previous Clinical Trials
1,700 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am currently cancer-free.I have been diagnosed with cancer before, regardless of the type or stage.I am 18 years old or older.I have been feeling anxious for at least a month.I scored 8 or higher for anxiety on a medical questionnaire.My cancer is either gone or not getting worse.I speak English or Spanish.I have undergone 7 or more therapy sessions for anxiety in the last 6 months.I am willing to follow the study's procedures and accept being assigned to either of the two treatment groups.I am unable to understand and give consent for my own treatment.I finished my cancer treatment less than a month ago, but may still be on maintenance therapy.
Research Study Groups:
This trial has the following groups:- Group 1: Music Therapy (MT)
- Group 2: Cognitive Behavioral Therapy (CBT)
Awards:
This trial has 3 awards, including:- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is Music Therapy formally sanctioned by the FDA?
"Music therapy has already been approved, so its safety is rated at 3."
Answered by AI
How many individuals are taking part in this medical research?
"Affirmative, the information hosted on clinicaltrials.gov confirms that this investigation is looking for participants at present. This work was publicly posted on January 14th 2022 and most recently revised in November 17th of the same year. 300 subjects will be sought from 2 different medical centres throughout its duration."
Answered by AI
Are new participants being enlisted for this clinical investigation?
"Affirmative. The information posted on clinicaltrials.gov affirms that the trial is actively looking for participants since it first went live on January 14th 2022 and was last updated November 17th 2022. 300 individuals are sought from two different sites."
Answered by AI
Who else is applying?
What state do they live in?
New York
How old are they?
18 - 65
What site did they apply to?
Memorial Sloan Kettering Cancer Center
What portion of applicants met pre-screening criteria?
Met criteria
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