Music Therapy for Pediatric Cancer

Recruiting at 3 trial locations

Overseen By Claire J Kendrick, MM

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Indiana University

Must not be taking: Steroids

Disqualifiers: Ph+ ALL, Cushing disease, Asthma, others

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

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

250 Participants Needed

Trial Summary

What is the purpose of this trial?

Music therapy has become a standard palliative care service in many pediatric and adult hospitals; however, a majority of music therapy research has focused on the use of music to improve psychosocial dimensions of health, without considering biological dimensions. This study builds on prior work examining the psychosocial mechanisms of action underlying an Active Music Engagement (AME) intervention, designed to help manage emotional distress and improve positive health outcomes in young children with cancer and parents, by examining its effects on biomarkers of stress and immune function. The purposes of this two group, randomized controlled trial are to examine biological mechanisms of effect and dose-response relationships of AME on child/parent stress during the consolidation phase of Acute Lymphoblastic Leukemia (ALL) treatment. Specific aims are to: Aim 1. Establish whether AME lowers child and parent cortisol during ALL treatment. Aim 2. Examine cortisol as a mediator of AME effects on child and parent outcomes during ALL treatment. Aim 3 (exploratory). Examine the dose-response relationship of AME on child and parent cortisol during ALL treatment. Findings will provide a more holistic understanding about how active music interventions work to mitigate cancer-related stress and its potential to improve immune function, with direct implications for the evidence-based use of music to improve health.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it excludes children taking steroid medication for asthma or those with uncontrolled asthma.

What data supports the effectiveness of the treatment Active Music Engagement for pediatric cancer patients?

Research shows that music therapy, including Active Music Engagement, can help children with cancer by reducing stress, improving mood, and enhancing their quality of life. It can also promote supportive relationships and provide a sense of normalcy and hope. ^{1 2 3 4 5}

Is music therapy safe for children with cancer?

Music therapy, including Active Music Engagement, is generally considered safe and is used in hospitals to help manage emotional distress and improve health outcomes in children with cancer. It can reduce pain, anxiety, and stress, and improve social interactions and emotional well-being. ^{1 3 5 6 7}

How is the Active Music Engagement treatment different from other treatments for pediatric cancer?

Active Music Engagement (AME) is unique because it uses music to help manage emotional distress and improve health outcomes by focusing on both psychosocial and biological aspects, such as stress and immune function, rather than just addressing physical symptoms like many traditional treatments. ^{1 2 3 4 8}

Research Team

Sheri L Robb, PhD

Principal Investigator

Indiana University

Eligibility Criteria

This trial is for children aged 3-8 with B- or T-cell acute lymphoblastic leukemia (ALL) or lymphoblastic lymphoma, currently in induction therapy. A parent over 18 must attend all sessions. Excluded are children with Ph+ ALL, Cushing disease, certain treatment protocols, uncontrolled asthma, steroid medication for asthma, non-English speaking parents, or significant cognitive impairments.

Inclusion Criteria

I can have a parent over 18 with me at all sessions.

My child has been diagnosed with a serious form of leukemia or lymphoma.

My child is between 3 and 8 years old.

Exclusion Criteria

I, as a parent, do not speak English.

The child has a significant cognitive impairment that might hinder participation (determination made in consultation with attending physician, oncologist, and parents).

My child is on steroids for asthma or their asthma isn't well managed.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Consolidation Treatment

Participants receive Active Music Engagement (AME) or attention control during the consolidation phase of ALL treatment. Sessions occur weekly with a focus on reducing stress and improving quality of life.

4-8 weeks

Weekly clinic visits

Follow-up

Participants are monitored for changes in stress biomarkers and quality of life post-treatment.

4 weeks

Treatment Details

Interventions

• Active Music Engagement
• Audio Storybooks

Trial Overview The study tests how Active Music Engagement (AME) and listening to audio storybooks affect stress hormones and immune function in young kids with cancer and their parents during ALL treatment. It's a randomized trial comparing the biological impact of these interventions.

Participant Groups

Group I: Active Music Engagement Experimental Treatment 1 Intervention

See intervention description.

Group II: Audio Storybooks Active Control 1 Intervention

See intervention description.

Active Music Engagement is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Active Music Engagement for:

• Palliative care for pediatric and adult cancer patients
• Management of emotional distress and stress in young children with cancer and their parents

Approved in European Union as Music Therapy for:

• Palliative care for cancer patients
• Rehabilitation and stress management in various medical conditions

Approved in Canada as Music Therapy for:

• Palliative care for cancer patients
• Mental health support and rehabilitation

Who Is Running the Clinical Trial?

Indiana University

Lead Sponsor

Trials

1,063

Recruited

1,182,000+

UCSF Benioff Children's Hospital Oakland

Collaborator

Trials

80

Recruited

19,100+

James Whitcomb Riley Hospital for Children

Collaborator

Trials

5

Recruited

2,400+

Riley Hospital for Children at Indiana University Health

Collaborator

Trials

1

Recruited

250+

Ann & Robert H Lurie Children's Hospital of Chicago

Collaborator

Trials

275

Recruited

5,182,000+

Children's Mercy Hospital Kansas City

Collaborator

Trials

261

Recruited

941,000+

National Institute of Nursing Research (NINR)

Collaborator

Trials

623

Recruited

10,400,000+

Findings from Research

This study involves 228 child/parent dyads undergoing treatment for pediatric cancer, examining the effects of Active Music Engagement (AME) on stress and immune function by measuring salivary cortisol and blood samples.

The trial aims to enhance understanding of how AME can biologically impact stress levels during cancer treatment, potentially leading to improved clinical practices in palliative care for young patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Protocol and biomarker strategy for a multi-site randomized controlled trial examining biological mechanisms and dosing of active music engagement in children with acute lymphoblastic leukemia and lymphoma and parents. Robb, SL., Russ, KA., Holochwost, SJ., et al.[2023]

Music therapy has been shown to improve psychological well-being and social relationships in children and adolescents with cancer, based on a review of 27 studies from a pool of 522 articles.

The interventions are generally well received by patients, families, and healthcare professionals, although there are gaps in the literature regarding the specifics of the therapy methods and outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The relevance of music therapy in paediatric and adolescent cancer patients: a scoping review. Rodríguez-Rodríguez, RC., Noreña-Peña, A., Chafer-Bixquert, T., et al.[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 provides significant emotional and psychological benefits for pediatric oncology patients, helping them develop a healthy self-image and cope with their illness.

The study highlights the importance of making preferred music and music therapy accessible to children undergoing cancer treatment, as it can promote calmness, relieve distress, and foster supportive relationships.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Music's relevance for children with cancer: music therapists' qualitative clinical data-mining research. O'Callaghan, C., Dun, B., Baron, A., et al.[2013]

The Active Music Engagement (AME + P) intervention was feasible for parents to deliver to their young children with cancer, as they were able to successfully conduct the activities.

Children who participated in the AME + P intervention showed lower emotional distress, but parents did not experience any emotional benefits from delivering the program, indicating that while the intervention helped children, it may not be suitable for parent delivery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pilot Randomized Trial of Active Music Engagement Intervention Parent Delivery for Young Children With Cancer. Robb, SL., Haase, JE., Perkins, SM., et al.[2023]

In a randomized clinical trial involving breast cancer patients undergoing chemotherapy, a 30-minute music intervention before treatment significantly improved quality of life scores compared to a control group.

The music group also experienced lower levels of depression and anxiety, as well as reduced incidence of vomiting during chemotherapy, indicating that music can be an effective complementary therapy to alleviate some adverse effects of cancer treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of a Music Intervention on Quality of Life in Breast Cancer Patients Undergoing Chemotherapy: A Randomized Clinical Trial. Lima, TU., Moura, ECR., Oliveira, CMB., et al.[2021]

The Music Attentiveness Screening Assessment (MASA) shows promise in measuring auditory attention in children aged 5 to 9, with a significant correlation to established auditory attention measures, indicating its potential utility in clinical settings.

Test-retest reliability for the MASA was moderately high for one item (r = .84) but lower for another (r = .63), suggesting that while MASA can assess attention, further refinement and validation are needed for consistent results.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Construct validity and reliability of the Music Attentiveness Screening Assessment (MASA). Waldon, EG., Broadhurst, E.[2019]

A systematic review of 19 studies involving 596 children and adolescents with cancer found that music therapy significantly reduces psychological distress and enhances well-being, indicating its effectiveness as a supportive treatment during hospitalization.

Despite the positive outcomes, the review highlighted challenges such as the variety of music therapy methods used, which complicates the ability to generalize the findings across different settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The role of music therapy in the treatment of children with cancer: A systematic review of literature. Facchini, M., Ruini, C.[2022]

References

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

Protocol and biomarker strategy for a multi-site randomized controlled trial examining biological mechanisms and dosing of active music engagement in children with acute lymphoblastic leukemia and lymphoma and parents. [2023]

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

The relevance of music therapy in paediatric and adolescent cancer patients: a scoping review. [2022]

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

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

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

Music's relevance for children with cancer: music therapists' qualitative clinical data-mining research. [2013]

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

Pilot Randomized Trial of Active Music Engagement Intervention Parent Delivery for Young Children With Cancer. [2023]

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

Impact of a Music Intervention on Quality of Life in Breast Cancer Patients Undergoing Chemotherapy: A Randomized Clinical Trial. [2021]

7. England pubmed.ncbi.nlm.nih.gov

Construct validity and reliability of the Music Attentiveness Screening Assessment (MASA). [2019]

8. England pubmed.ncbi.nlm.nih.gov

The role of music therapy in the treatment of children with cancer: A systematic review of literature. [2022]