Clinical trial NCT02583139: Designed Music Narratives for the Reduction of Side Effects of Chemotherapy in Children (7-12 Years) With Cancer
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cancer
Chemotherapy-induced Nausea and Vomiting
Effects of Chemotherapy
Keywords: Children, Moderate and/or highly emetogenic chemotherapy
Lead sponsor: University of Aarhus
Sponsor class: OTHER
Collaborators: name: Danish Cancer Society
name: Børnecancerfonden
name: Ronald McDonalds Børnefond
name: TrygFonden, Denmark
First posted: 2015-10-22
Enrollment: 68
Sex: ALL
Minimum age (years): 7
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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: (Will be added later)

Eligibility 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

Primary outcomes:
measure: Duration (minutes) of Acute Nausea
timeFrame: Registered the two first evenings within the first 32 hours after onset of chemotherapy during 5th cycle of chemotherapy after enrolment in study
Secondary outcomes:
measure: Intensity of Acute Nausea as measured by the Visual Analogue Scale
timeFrame: Registered the two first evenings within the first 32 hours after onset of chemotherapy during 5th cycle of chemotherapy after enrolment in study
measure: Distress regarding Acute Nausea as measured by the Visual Analogue Scale
timeFrame: Registered the two first evenings within the first 32 hours after onset of chemotherapy during 5th cycle of chemotherapy after enrolment in study
measure: Amount (mg/m2) of Nausea Reducing Medicine Consumed
timeFrame: During admission (an expected average of 3 days) and the first three days after discharge regarding 5th cycle of chemotherapy after enrolment in study
measure: Multiple Acute Side Effects of Chemotherapy as measured by the Memorial Symptom Assessment Scale
timeFrame: Registered the two first evenings within the first 32 hours after onset of chemotherapy during 5th cycle of chemotherapy after enrolment in study
measure: Numbers of Acute Vomiting
timeFrame: Registered the two first evenings within the first 32 hours after onset of chemotherapy during 5th cycle of chemotherapy after enrolment in study
measure: Duration (minutes) of Acute Pain
timeFrame: Registered the two first evenings within the first 32 hours after onset of chemotherapy during 5th cycle of chemotherapy after enrolment in study
measure: Acute Pain Intensity as measured by the Visual Analogue Scale
timeFrame: Registered the two first evenings within the first 32 hours after onset of chemotherapy during 5th cycle of chemotherapy after enrolment in study
measure: Number of Days to Absolute Neutrophil Count Recovery (ANCR) defined as ANCR ≥ 0.5 x 109/L
timeFrame: 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)
measure: Duration (minutes) of Acute Fatigue
timeFrame: Registered the two first evenings within the first 32 hours after onset of chemotherapy during 5th cycle of chemotherapy after enrolment in study
measure: Distress of Acute Fatigue as measured by a 5-point Likert-type Scale
timeFrame: Registered the two first evenings within the first 32 hours after onset of chemotherapy during 5th cycle of chemotherapy after enrolment in study
measure: Appraised Food Intake and Appetite as measured by a 5-point Likert-type Scale
timeFrame: Registered the two first evenings within the first 32 hours after onset of chemotherapy during 5th cycle of chemotherapy after enrolment in study
measure: Weight (kg)
timeFrame: Change between weight from during course 1 and course 5 after inclusion in study
measure: Satisfaction with Applied Music Intervention as measured by a Likert-type Scale (participants in music group only)
timeFrame: Last day (i.e. expected 3rd or 4th day) of 5th cycle of chemotherapy after enrolment in study
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Aarhus University Hospital
Study officials:
affiliation: Aarhus University Hospistal
name: Ilan Sanfi, PhD
role: PRINCIPAL_INVESTIGATOR
References: