Cancer, Chemotherapy-induced Nausea and Vomiting, Effects of Chemotherapy
Conditions
Keywords
Children, Moderate and/or highly emetogenic chemotherapy
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)
Interventions
BEHAVIORALDesigned 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.
Sponsors
Danish Cancer Society
Børnecancerfonden
Ronald McDonalds Børnefond
TrygFonden, Denmark
University of Aarhus
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
7 Years to 12 Years
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Duration (minutes) of Acute Nausea | Registered the two first evenings within the first 32 hours after onset of chemotherapy during 5th cycle of chemotherapy after enrolment in study | Self-reported duration og nausea in minutes within the first 32 hours after onset of chemothera |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Distress regarding Acute Nausea as measured by the Visual Analogue Scale | Registered the two first evenings within the first 32 hours after onset of chemotherapy during 5th cycle of chemotherapy after enrolment in study | Self-reported distress regarding nausea, calculated as the average of the two measurements |
| 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 | Registered the two first evenings within the first 32 hours after onset of chemotherapy during 5th cycle of chemotherapy after enrolment in study | 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 |
| Numbers of Acute Vomiting | Registered the two first evenings within the first 32 hours after onset of chemotherapy during 5th cycle of chemotherapy after enrolment in study | Self-reported numbers of vomiting during the first 32 hours |
| Duration (minutes) of Acute Pain | Registered the two first evenings within the first 32 hours after onset of chemotherapy during 5th cycle of chemotherapy after enrolment in study | Self-reported duration of acute pain in minutes within the first 32 hours after onset of chemotherapy |
| Acute Pain Intensity as measured by the Visual Analogue Scale | Registered the two first evenings within the first 32 hours after onset of chemotherapy during 5th cycle of chemotherapy after enrolment in study | Self-reported intensity of pain, calculated as the average of the two measurements |
| Intensity of Acute Nausea as measured by the Visual Analogue Scale | Registered the two first evenings within the first 32 hours after onset of chemotherapy during 5th cycle of chemotherapy after enrolment in study | Self-reported intensity of nausea, calculated as the average of the two measurements |
| Duration (minutes) of Acute Fatigue | Registered the two first evenings within the first 32 hours after onset of chemotherapy during 5th cycle of chemotherapy after enrolment in study | Self-reported duration of acute fatigue in minutes within the first 32 hours after onset of chemotherapy |
| Distress of Acute Fatigue as measured by a 5-point Likert-type Scale | Registered the two first evenings within the first 32 hours after onset of chemotherapy during 5th cycle of chemotherapy after enrolment in study | Self-reported Distress regarding Acute Fatigue, calculated as the average of the two measurements |
| Appraised Food Intake and Appetite as measured by a 5-point Likert-type Scale | Registered the two first evenings within the first 32 hours after onset of chemotherapy during 5th cycle of chemotherapy after enrolment in study | Self-reported appraised food intake, calculated as the average of the two measurements |
| 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) | Last day (i.e. expected 3rd or 4th day) of 5th cycle of chemotherapy after enrolment in study | Self-report, registered once during 5th cycle of chemotherapy |
| Number of Days to Absolute Neutrophil Count Recovery (ANCR) defined as ANCR ≥ 0.5 x 109/L | 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) | 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) |
Countries
Denmark
Contacts
Primary ContactIlan Sanfi, PhD
Backup ContactStine C. Ærø, BA
Outcome results
None listed