Music Therapy for Pediatric Cancer

No longer 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how music therapy can manage stress and improve health outcomes for young children with cancer and their parents. Specifically, it examines whether an Active Music Engagement (AME) intervention can lower stress hormones and boost immune function during leukemia treatment. Participants will either engage in music therapy or listen to audio storybooks to determine which is more effective. Children aged 3 to 8 undergoing treatment for specific types of leukemia or lymphoma, and not on certain medications, may be eligible. The goal is to determine if music can effectively reduce stress in these young patients and their families. As an unphased trial, this study provides a unique opportunity to explore innovative ways to support emotional and physical health during treatment.

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 prior data suggests that Active Music Engagement and Audio Storybooks are safe for children with cancer?

Research has shown that Active Music Engagement (AME) is generally safe for children with cancer. Studies have found that it not only reduces emotional distress but also supports positive health outcomes. Parents report that AME helps cope with the stress of cancer treatment, indicating it is well-received by both children and their families. The reviewed studies reported no negative effects. AME appears to be a safe and supportive option for managing stress in young cancer patients. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Active Music Engagement for pediatric cancer patients because it offers a refreshing approach compared to traditional treatments like chemotherapy and radiation. Unlike these standard treatments, which focus on directly targeting cancer cells, Active Music Engagement aims to improve the emotional and psychological well-being of young patients, potentially reducing anxiety and enhancing quality of life during treatment. This approach leverages the power of music to engage children in a way that is non-invasive and enjoyable, making it a unique and promising adjunct therapy in the holistic care of pediatric cancer patients.

What evidence suggests that this trial's treatments could be effective for pediatric cancer?

Research shows that Active Music Engagement (AME), a treatment in this trial, can reduce stress and improve well-being in children with cancer and their parents. Studies have found that AME lowers anxiety and enhances the quality of life for kids undergoing cancer treatment. It also helps young children with cancer develop better coping skills. For parents, AME lessens distress and symptoms of traumatic stress. These findings suggest that AME might effectively manage stress and could even help boost the immune system during cancer treatment. Another treatment arm in this trial involves Audio Storybooks, which researchers will compare to AME to evaluate their effectiveness. ^{1 6 7 8 9}

Who Is on the Research Team?

Sheri L Robb, PhD

Principal Investigator

Indiana University

Are You a Good Fit for This Trial?

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

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.

My child has Ph+ acute lymphoblastic leukemia.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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]

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]

Citations

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pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/38145309/

Mediators and Moderators of Active Music Engagement to ...

Conclusions: AME is a promising intervention for mitigating traumatic stress symptoms and supporting well-being in parents of children with cancer, particularly ...

2.

clinicaltrials.gov

clinicaltrials.gov/study/NCT03085927

Mechanisms of Active Music Engagement to Improve ...

This study investigates behavioral, social, and psychological factors that may explain how an Active Music Engagement (AME) intervention (ie, an interactive, ...

3.

sciencedirect.com

sciencedirect.com/science/article/pii/S0965229921000662

MUSIC INTERVENTIONS IN PEDIATRIC ONCOLOGY

There is evidence to support the use of music to reduce pain and anxiety and improve quality of life in children undergoing cancer treatment. Despite the high ...

4.

frontiersin.org

frontiersin.org/journals/psychology/articles/10.3389/fpsyg.2025.1550051/full

Who benefits from active music engagement during cancer ...

Lowering parent distress and TSS during treatment is associated with lower child distress, improved health-related quality of life, and better ...

5.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/18033724/

A non-randomized [corrected] controlled trial of the active ...

This study supports the use of the AME intervention to encourage coping-related behaviors in hospitalized children aged 4-7 receiving cancer treatment.

6.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/38337169/

Parent perspectives of an active music engagement ...

Conclusions: This work elucidates how AME works to counteract stressful qualities of cancer treatment. As parents witnessed positive and ...

7.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10750508/

Mediators and Moderators of Active Music Engagement ...

This study elucidates mechanisms of an active music engagement intervention on clinical outcomes in young children with cancer and parents.

8.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S1744388120311646

The role of music therapy in the treatment of children ...

Music therapy, in paediatric oncology, seems to have a good feasibility and positive effects on mental and physical health.

9.

oncologynurseadvisor.com

oncologynurseadvisor.com/news/acute-cancer-music-intervention-transforms-parents-perspective-treatment/

Music Intervention Transforms Parents' Perspective During ...

Active music engagement proved to be a developmentally appropriate and effective coping mechanism for parents and their child with cancer.