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Official title A Study Comparing Music Therapy and Cognitive Behavioral Therapy for Anxiety in Cancer Survivors
ClinicalTrials.gov ID: NCT05215353
What this study is testing
- What it's testing
- 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.
- Phase 4: studies an already-approved treatment
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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)
You likely can't join if
- Completed active cancer treatment (e.g., surgery, radiation, chemotherapy) less than one month prior to enrollment (maintenance hormonal or targeted...
- 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
See the full eligibility 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 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...
- 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 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Miami, Florida, United States
- New York, New York, United States
- Philadelphia, Pennsylvania, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Miami, Florida, United States; New York, New York, United States; Philadelphia, Pennsylvania, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.