Music Therapy vs Cognitive Behavioral Therapy for Anxiety in Cancer Survivors

Recruiting at 2 trial locations

Overseen By Jun Mao, MD, MSCE

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Memorial Sloan Kettering Cancer Center

Must not be taking: Anxiety medications

Disqualifiers: Suicidal ideation, Bipolar, Schizophrenia, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 26 weeks

350 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Do I need to stop my current medications to join the trial?

The trial does not specify if you need to stop your current medications, but you cannot join if you plan to start or change anxiety medications in the next 8 weeks.

What data supports the effectiveness of this treatment for anxiety in cancer survivors?

Research shows that music therapy can help reduce anxiety in cancer patients, especially when personalized to their preferences. Studies have found that music therapy can improve mood and reduce stress, making it a promising treatment for anxiety in cancer survivors. ^{1 2 3 4 5}

Is music therapy safe for cancer survivors?

Music therapy is generally considered safe and can help improve mood, reduce stress, and enhance relaxation for cancer patients. It is used as a supportive care method to promote physical and emotional well-being during treatment. ^{4 6 7 8 9}

How does music therapy differ from other treatments for anxiety in cancer survivors?

Music therapy is unique because it uses music-based activities, like listening to or creating music, to help reduce anxiety and improve mood in cancer patients. Unlike traditional therapies, it can be integrated into supportive cancer care to enhance emotional well-being and quality of life without relying on medication. ^{4 6 7 10 11}

Research Team

Jun Mao, MD, MSCE

Principal Investigator

Memorial Sloan Kettering Cancer Center

Eligibility Criteria

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.

Inclusion Criteria

Access to Zoom and a quiet/private location

I have been diagnosed with cancer before, regardless of the type or stage.

I am 18 years old or older.

Exclusion Criteria

Active suicidal ideation, bipolar disorder, schizophrenia, or substance abuse

Score of ≥10 indicative of cognitive impairment on the Blessed Orientation-Memory-Concentration

I have undergone 7 or more therapy sessions for anxiety in the last 6 months.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either music therapy or cognitive behavioral therapy virtually to reduce anxiety

26 weeks

Virtual sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Cognitive Behavioral Therapy
• Music Therapy

Trial Overview 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.

Participant Groups

Group I: Music Therapy (MT) Experimental Treatment 2 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 Control 2 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.

Cognitive Behavioral Therapy is already approved in European Union, United States, Canada for the following indications:

Approved in European Union as Cognitive Behavioral Therapy for:

• Anxiety disorders
• Depressive disorders
• Eating disorders
• Post-traumatic stress disorder (PTSD)
• Obsessive-compulsive disorder (OCD)

Approved in United States as Cognitive Behavioral Therapy for:

• Anxiety disorders
• Depressive disorders
• Eating disorders
• Post-traumatic stress disorder (PTSD)
• Obsessive-compulsive disorder (OCD)
• Substance use disorders

Approved in Canada as Cognitive Behavioral Therapy for:

• Anxiety disorders
• Depressive disorders
• Eating disorders
• Post-traumatic stress disorder (PTSD)
• Obsessive-compulsive disorder (OCD)

Who Is Running the Clinical Trial?

Memorial Sloan Kettering Cancer Center

Lead Sponsor

Trials

1,998

Recruited

602,000+

Patient-Centered Outcomes Research Institute

Collaborator

Trials

592

Recruited

27,110,000+

Findings from Research

A study involving 65 cancer patients found that there is a strong interest in music therapy, particularly in music listening, which could enhance patient comfort and engagement in therapeutic interventions.

The patients' preferences for music therapy were linked to factors such as their levels of anxiety, negative emotions, age, and their beliefs about the benefits and barriers of the therapy, indicating the importance of tailoring interventions to individual patient needs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cancer patients' interest and preferences for music therapy. Burns, DS., Sledge, RB., Fuller, LA., et al.[2019]

In a clinical trial involving 120 female breast cancer patients, music therapy significantly reduced state anxiety levels compared to routine nursing care alone, with lower anxiety scores observed at three different post-test measurements.

The study demonstrated that music therapy can be an effective complementary intervention for managing anxiety in patients following radical mastectomy, highlighting its potential role in holistic cancer care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of music therapy on anxiety of patients with breast cancer after radical mastectomy: a randomized clinical trial. Li, XM., Zhou, KN., Yan, H., et al.[2022]

Music therapy is gaining recognition as an effective integrative oncology practice, with increasing evidence from randomized controlled trials demonstrating its positive impact on patients' quality of life.

Personalization of music therapy is crucial, as individual music preferences and cultural backgrounds significantly influence its effectiveness, highlighting the need for tailored approaches in cancer care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Addressing the need for personalizing music therapy in integrative oncology. Rajendran, T.[2022]

A systematic review of 13 studies involving 946 cancer patients found that music therapy (MT) can be effective in reducing anxiety and distress associated with radiation treatment (RT).

The review highlights the potential of MT as a supportive intervention for oncology patients, suggesting it may improve their emotional well-being before and during RT, although further research is needed to address clinical management challenges.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Music therapy and radiation oncology: State of art and future directions. Nardone, V., Vinciguerra, C., Correale, P., et al.[2020]

Mindfulness-based music therapy (MBMT) significantly improved attention in women with breast cancer undergoing chemotherapy, as shown by a repeated measures analysis of variance.

Participants also experienced notable improvements in mood, particularly a significant reduction in fatigue, highlighting MBMT as a beneficial intervention for managing mood distress during treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Effect of Mindfulness-Based Music Therapy on Attention and Mood in Women Receiving Adjuvant Chemotherapy for Breast Cancer: A Pilot Study. Lesiuk, T.[2015]

Music therapy is an effective complementary treatment for cancer patients, helping to improve mood, reduce stress, pain, and anxiety, and enhance relaxation during their treatment process.

Integrating music therapy into supportive cancer care can significantly promote overall wellness and improve both physical and emotional well-being, contributing to a better quality of life for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Music therapy in supportive cancer care. Stanczyk, MM.[2022]

Music therapy can significantly help pediatric oncology patients by addressing physical, social, and psychological needs, such as reducing pain and anxiety, and decreasing reliance on pain medication.

It promotes social interaction and emotional expression, enhancing relationships with healthcare providers and family, which is crucial for patients undergoing long-term treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Music therapy research and applications in pediatric oncology treatment. Standley, JM., Hanser, SB.[2017]

Music therapy and music medicine have been shown to have positive effects on children and adolescents with various psychiatric disorders, including mood/anxiety disorders and substance abuse, highlighting their potential as effective treatment options.

The article discusses the need for further research to better understand the mechanisms of action and to strengthen the evidence base for music therapy in psychiatric treatment, while also providing practical suggestions for healthcare professionals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Music therapy and music medicine for children and adolescents. Yinger, OS., Gooding, L.[2022]

There is a significant lack of quantitative research on the effects of music therapy for individuals with mental illnesses, despite its potential to treat various clinical populations.

This study analyzes high-quality research methods from cognitive behavioral therapy (CBT) to propose improved methodologies for future music therapy research, aiming to strengthen the evidence base and enhance treatment for mental health patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Quantitative comparison of cognitive behavioral therapy and music therapy research: a methodological best-practices analysis to guide future investigation for adult psychiatric patients. Silverman, MJ.[2019]

A systematic review of 13 trials involving 606 breast cancer patients found that arts therapies, including music and art therapy, significantly reduce anxiety levels, with a standardized mean difference of -1.10.

However, the review did not find significant effects of arts therapies on depression, quality of life, pain, or other emotional states, indicating that while beneficial for anxiety, their overall impact on other aspects of well-being remains unclear.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Arts therapies for anxiety, depression, and quality of life in breast cancer patients: a systematic review and meta-analysis. Boehm, K., Cramer, H., Staroszynski, T., et al.[2023]

Music therapy (MT) significantly reduced anxiety and distress in patients undergoing radiation therapy, as evidenced by a decrease in STAI-S Anxiety scores from 39.1 to 31.0 and SDT scores from 3.2 to 1.7 in the MT group.

In contrast, patients who did not receive music therapy showed no significant change in anxiety or distress levels, highlighting the potential of individualized music therapy as an effective intervention for improving patient experience during stressful medical procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Impact of Music Therapy on Anxiety in Cancer Patients Undergoing Simulation for Radiation Therapy. Rossetti, A., Chadha, M., Torres, BN., et al.[2021]

References

1. England pubmed.ncbi.nlm.nih.gov

Cancer patients' interest and preferences for music therapy. [2019]

2. England pubmed.ncbi.nlm.nih.gov

Effects of music therapy on anxiety of patients with breast cancer after radical mastectomy: a randomized clinical trial. [2022]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Addressing the need for personalizing music therapy in integrative oncology. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Music therapy and radiation oncology: State of art and future directions. [2020]

5. United States pubmed.ncbi.nlm.nih.gov

The Effect of Mindfulness-Based Music Therapy on Attention and Mood in Women Receiving Adjuvant Chemotherapy for Breast Cancer: A Pilot Study. [2015]

6. Poland pubmed.ncbi.nlm.nih.gov

Music therapy in supportive cancer care. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Music therapy research and applications in pediatric oncology treatment. [2017]

8. United States pubmed.ncbi.nlm.nih.gov

Music therapy and music medicine for children and adolescents. [2022]

9. England pubmed.ncbi.nlm.nih.gov

Quantitative comparison of cognitive behavioral therapy and music therapy research: a methodological best-practices analysis to guide future investigation for adult psychiatric patients. [2019]

10. United States pubmed.ncbi.nlm.nih.gov

Arts therapies for anxiety, depression, and quality of life in breast cancer patients: a systematic review and meta-analysis. [2023]

11. United States pubmed.ncbi.nlm.nih.gov

The Impact of Music Therapy on Anxiety in Cancer Patients Undergoing Simulation for Radiation Therapy. [2021]