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

University of Aarhus

Status: Unknown

Conditions: Chemotherapy-induced Nausea and Vomiting; Effects of Chemotherapy; Cancer

Treatments: Behavioral: Designed Music Narratives

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02583139

MF-Cancer-Children-1

Details and patient eligibility

About

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.

Full description

(Will be added later)

Enrollment: 68 estimated patients

Sex: All

Ages: 7 to 12 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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68 participants in 2 patient groups

Music Narrative Group

Experimental group

Description:

Prescribed medical/chemotherapy treatment plus standard care + Designed Music Narratives

Treatment:

Behavioral: Designed Music Narratives

Control Group

No Intervention group

Description:

Prescribed medical/chemotherapy treatment plus standard care