Designed Music Narratives for the Reduction of Side Effects of Chemotherapy in Children (7-12 Years) With Cancer

Study Overview
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Brief Summary
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The purpose of this study is to determine whether a specially-designed music-narratives are effective in reducing side effects of chemotherapy in 7- to 12-year-olds with cancer.

Detailed Description
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(Will be added later)

Official Title
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The Effect and Meaning of Designed Music Narratives on Anticipatory, Acute, and Delayed Side Effect of Chemotherapy in Children (7-12 Years) With Cancer: a Randomized Controlled Multisite Study

Conditions
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Cancer, Chemotherapy-induced Nausea and Vomiting, Effects of Chemotherapy

Intervention / Treatment
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* Behavioral: Designed Music Narratives


Participation Criteria
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Eligibility Criteria
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Children at the ages 7-12 Four or five (dependent on their overall plan of medical treatment) consecutive courses of chemotherapy administrated at the involved child cancer units and (administered) over a period of minimum 24 hours incl. hydration with assumed moderate to severe nausea and vomiting. The specific type of chemotherapy may vary across the four/five consecutive courses but shall include one of the following moderate and/or highly emetogenic types of chemotherapy: Moderate emetogenic chemotherapy: Carboplatin Cyclophosphamide <1500 mg/m2 Cytarabine >1 g/m2 Daunorubicin Doxorubicin Epirubicin Idarubicin Ifosfamide Mitoxantrone Methotrexate >1000 mg/m2 Highly emetogenic chemotherapy: Cisplatin >25 mg/m2 Cyclophosphamide >1500 mg/m2 Dacarbazine Understand Norwegian/Danish Parents must be able to read and understand Norwegian/Danish No significant hearing impairment Written and verbal informed consent from both possessors of the custody Verbal informed consent from child/participant Exclusion Criteria: Previous and/or acute psychiatric diagnosis Cognitive and mental deficits or impaired functioning

Ages Eligible for Study
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Minimum Age: 7 Years
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Music Narrative Group<br>Prescribed medical/chemotherapy treatment plus standard care + Designed Music Narratives | Behavioral: Designed Music Narratives<br>* Four music narratives for children each comprising an introductory relaxation exercise, a resource-oriented narrative including guided imagery suggestions and relaxing nature scenarios plus especially composed music. The narrative and music reflect and support each other.<br>|
| No Intervention: Control Group<br>Prescribed medical/chemotherapy treatment plus standard care | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration (minutes) of Acute Nausea | Self-reported duration og nausea in minutes within the first 32 hours after onset of chemothera | Registered the two first evenings within the first 32 hours after onset of chemotherapy during 5th cycle of chemotherapy after enrolment in study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intensity of Acute Nausea as measured by the Visual Analogue Scale | Self-reported intensity of nausea, calculated as the average of the two measurements | Registered the two first evenings within the first 32 hours after onset of chemotherapy during 5th cycle of chemotherapy after enrolment in study | 
| Distress regarding Acute Nausea as measured by the Visual Analogue Scale | Self-reported distress regarding nausea, calculated as the average of the two measurements | Registered the two first evenings within the first 32 hours after onset of chemotherapy during 5th cycle of chemotherapy after enrolment in study | 
| Amount (mg/m2) of Nausea Reducing Medicine Consumed |  | During admission (an expected average of 3 days) and the first three days after discharge regarding 5th cycle of chemotherapy after enrolment in study | 
| Multiple Acute Side Effects of Chemotherapy as measured by the Memorial Symptom Assessment Scale | Self-reported side effects, calculated as the average of the two measurements. The Memorial Symptom Assessment Scale is a self-report composite measure that measures bodily and psychological symptoms of side effects | Registered the two first evenings within the first 32 hours after onset of chemotherapy during 5th cycle of chemotherapy after enrolment in study | 
| Numbers of Acute Vomiting | Self-reported numbers of vomiting during the first 32 hours | Registered the two first evenings within the first 32 hours after onset of chemotherapy during 5th cycle of chemotherapy after enrolment in study | 
| Duration (minutes) of Acute Pain | Self-reported duration of acute pain in minutes within the first 32 hours after onset of chemotherapy | Registered the two first evenings within the first 32 hours after onset of chemotherapy during 5th cycle of chemotherapy after enrolment in study | 
| Acute Pain Intensity as measured by the Visual Analogue Scale | Self-reported intensity of pain, calculated as the average of the two measurements | Registered the two first evenings within the first 32 hours after onset of chemotherapy during 5th cycle of chemotherapy after enrolment in study | 
| Number of Days to Absolute Neutrophil Count Recovery (ANCR) defined as ANCR ≥ 0.5 x 109/L | Number of days before the immune system recovers after chemotherapy. In the study, Absolute Neutrophil Count Recovery (ANCR) is defined as ANCR ≥ 0.5 x 109/L. In addition, if no nadir < 0.5 x 109/L occurs the period is 0 (zero) | Time to Event: Measured Day 1 in 5th cycle of chemotherapy after enrolment in study - until first day with ANC ≥ 0.5 x 109/L after the nadir period (an expected average of 9-15 days) | 
| Duration (minutes) of Acute Fatigue | Self-reported duration of acute fatigue in minutes within the first 32 hours after onset of chemotherapy | Registered the two first evenings within the first 32 hours after onset of chemotherapy during 5th cycle of chemotherapy after enrolment in study | 
| Distress of Acute Fatigue as measured by a 5-point Likert-type Scale | Self-reported Distress regarding Acute Fatigue, calculated as the average of the two measurements | Registered the two first evenings within the first 32 hours after onset of chemotherapy during 5th cycle of chemotherapy after enrolment in study | 
| Appraised Food Intake and Appetite as measured by a 5-point Likert-type Scale | Self-reported appraised food intake, calculated as the average of the two measurements | Registered the two first evenings within the first 32 hours after onset of chemotherapy during 5th cycle of chemotherapy after enrolment in study | 
| Weight (kg) |  | Change between weight from during course 1 and course 5 after inclusion in study | 
| Satisfaction with Applied Music Intervention as measured by a Likert-type Scale (participants in music group only) | Self-report, registered once during 5th cycle of chemotherapy | Last day (i.e. expected 3rd or 4th day) of 5th cycle of chemotherapy after enrolment in study | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Children, Moderate and/or highly emetogenic chemotherapy