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

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

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.

Study Overview

• Status: Unknown
• Conditions: Cancer; Chemotherapy-induced Nausea and Vomiting; Effects of Chemotherapy
• Intervention / Treatment: Behavioral: Designed Music Narratives

Detailed Description

(Will be added later)

• Study Type: Interventional
• Enrollment (Anticipated): 68
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ilan Sanfi, PhD; Phone Number: +4522973661; Email: ilan@sanfi.dk
• Study Contact Backup: Name: Stine C. Ærø, BA; Phone Number: +47 92498316; Email: sero@ous-hf.no

Study Locations

• Denmark
  • Aarhus, Denmark, 8200
    • Recruiting
    • Aarhus University Hospital
    • Contact: Lisbeth Rasmussen; Phone Number: +45 78 45 14 70; Email: lisbeth.rasmussen@skejby.rm.dk
    • Sub-Investigator: Henrik Hasle, Prof. PhD MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 7 years to 12 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

1. Children at the ages 7-12

2. 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
3. Understand Norwegian/Danish

4. 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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Music Narrative Group; Prescribed medical/chemotherapy treatment plus standard care + Designed Music Narratives	Behavioral: Designed Music Narratives; 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.
No Intervention: Control Group; Prescribed medical/chemotherapy treatment plus standard care

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Aarhus
• Collaborators: Danish Cancer Society; TrygFonden, Denmark; Børnecancerfonden; Ronald McDonalds Børnefond
• Investigators: Principal Investigator: Ilan Sanfi, PhD, Aarhus University Hospistal

Study record dates

Study Major Dates

• Study Start: August 1, 2014
• Primary Completion (Anticipated): June 1, 2018
• Study Completion (Anticipated): December 1, 2018

Study Registration Dates

• First Submitted: February 3, 2015
• First Submitted That Met QC Criteria: October 19, 2015
• First Posted (Estimate): October 22, 2015

Study Record Updates

• Last Update Posted (Estimate): May 12, 2016
• Last Update Submitted That Met QC Criteria: May 11, 2016
• Last Verified: May 1, 2016

More Information

Terms related to this study

• Keywords: Children, Moderate and/or highly emetogenic chemotherapy
• Additional Relevant MeSH Terms: Signs and Symptoms, Digestive; Vomiting
• Other Study ID Numbers: MF-Cancer-Children-1

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No