Music Therapy for Pediatric Cancer

Recruiting in Palo Alto (17 mi)

+3 other locations

Overseen by Sheri L Robb, PhD

Age: < 18

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Indiana University

Must not be taking: Steroids

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

No Placebo Group

Approved in 3 Jurisdictions

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}

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.

Trial 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 (Behavioral)
• Audio Storybooks (Behavioral)

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

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

UCSF Benioff Children's Hospital Oakland, CA

Children's Mercy Hospital Kansas City, MO

Ann & Robert H. Lurie Children's Hospital of Chicago Chicago, IL

Riley Hospital for Children Indianapolis, IN

Who Is Running the Clinical Trial?

Indiana University Lead Sponsor

UCSF Benioff Children's Hospital Oakland Collaborator

James Whitcomb Riley Hospital for Children Collaborator

Riley Hospital for Children at Indiana University Health Collaborator

Ann & Robert H Lurie Children's Hospital of Chicago Collaborator

Children's Mercy Hospital Kansas City Collaborator

National Institute of Nursing Research (NINR) Collaborator

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] Music therapy is a standard palliative care service in many pediatric and adult hospitals; however, most 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 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 (caregivers), by examining its effects on biomarkers of stress and immune function.

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

The relevance of music therapy in paediatric and adolescent cancer patients: a scoping review. [2022] Music therapy is an emerging and useful methodology to improve the quality of life of children and adolescents with cancer.

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

Music therapy research and applications in pediatric oncology treatment. [2017] Music therapy is a profession which meets multiple physical, social, and psychological needs. Music therapists can facilitate health objectives by reducing the intensity or duration of pain, alleviating anxiety, and decreasing the amount of analgesic medication needed. Rehabilitative objectives can include activities which incorporate exercise, range of motion therapy, or gait training. Reduction of fear, anxiety, stress, or grief are common psychological objectives. Music therapy is particularly effective in promoting social objectives such as increased interaction, verbalization, independence, and cooperation; enhanced relationships with health care personnel and family members; and increased stimulation during long-term hospitalization or isolation. Counseling techniques are often paired with music to achieve emotional objectives such as expression, adjustment, stability, or locus of control. The purpose of this article is to synthesize the extant music/medical research literature and clarify how music therapy can provide a quintessential combination of physical, social, and psychological benefits to enhance the health care of pediatric oncology patients.

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

Music's relevance for children with cancer: music therapists' qualitative clinical data-mining research. [2013] Music is central in most children's lives. Understanding its relevance will advance efficacious pediatric supportive cancer care. Qualitative clinical data-mining uncovered four music therapists' perspectives about music and music therapy's relevance for pediatric oncology patients up to 14 years old. Inductive and comparative thematic analysis was performed on focus group transcripts and qualitative interrater reliability integrated. Music can offer children a safe haven for internalizing a healthy self-image alongside patient identity. Music therapy can calm, relieve distress, promote supportive relationships, enable self-care, and inspire playful creativity, associated with "normalcy" and hope. Preferred music and music therapy should be available in pediatric oncology.

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

Pilot Randomized Trial of Active Music Engagement Intervention Parent Delivery for Young Children With Cancer. [2023] To examine the feasibility/acceptability of a parent-delivered Active Music Engagement (AME + P) intervention for young children with cancer and their parents. Secondary aim to explore changes in AME + P child emotional distress (facial affect) and parent emotional distress (mood; traumatic stress symptoms) relative to controls.

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] Background: Music can influence human behavior and may be used as a complementary therapy in health care. Objectives: To assess the effect of music interventions on symptoms, adverse events, and quality of life (QoL) of breast cancer patients undergoing chemotherapy (CT). Design: Nonblinded, randomized clinical trial. Women with breast cancer undergoing adjuvant CT were randomized into 2 groups-Group Music (GM) or Group Control (GC)-and followed during the first 3 cycles of treatment. Measurements: Sociodemographic data, WHOQOL-BREF, BDI-II, BAI, and Chemotherapy Toxicity Scale were assessed. Patients were evaluated after each session of the first 3 CT cycles. GM underwent a 30-minute musical intervention before CT. There was no intervention in the GC. Continuous data were analyzed by Student's t test, and &#967;2 test was used to compare qualitative variables. Results: Higher QoL scores on functional scales were observed for the GM in comparison to the GC after the first and third sessions of CT. Depression (P &lt; .001) and anxiety scores (P &lt; .001) and vomiting (P &lt; .01) incidence were lower for the GM in the third session of CT. All the participants in the GM reported positive changes in life in the Subjective Impression of the Subject questionnaire, as well as improvement in fatigue and reduced stress levels. Conclusions: Improvements in QoL, anxiety, depression, and incidence of vomiting were associated with the music intervention, suggesting a positive effect of the music intervention on adverse events of cancer CT.

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

Construct validity and reliability of the Music Attentiveness Screening Assessment (MASA). [2019] Music as alternate engagement (MAE) can be used effectively to distract children during painful or anxiety-provoking medical procedures. For such interventions to be successful, it would seem important to assess the degree to which a child can attend to musical stimuli.

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] and purpose: Music Therapy has become a consolidated strategy to relief stress in children during hospitalization, and previous research demonstrated its efficacy on individuals' health. This is a systematic review of literature on the application of music therapy with children and adolescent with cancer, with the aim of evaluating its feasibility and its benefits, in terms of physical and mental health.