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

Not Applicable

• Conditions: Effects of Chemotherapy; Cancer; Chemotherapy-induced Nausea and Vomiting
• Interventions: Behavioral: Designed Music Narratives

• Registration Number: NCT02583139
• Lead Sponsor: University of Aarhus

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)

Study Timeline

• Study Start: 2014-08
• Study First Submitted: 2015-02-03
• Study First Submitted QC: 2015-10-19
• Study First Posted: 2015-10-22
• Status Verified: 2016-05
• Last Update Submitted: 2016-05-11
• Last Update Posted: 2016-05-12
• Primary Completion: 2018-06
• Study Completion: 2018-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 68

Inclusion Criteria

Not provided

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Exclusion Criteria

• Previous and/or acute psychiatric diagnosis
• Cognitive and mental deficits or impaired functioning

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Music Narrative Group	Designed Music Narratives	Prescribed medical/chemotherapy treatment plus standard care + Designed Music Narratives

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
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
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
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
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)
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

Trial Locations

Locations (1)

Aarhus University Hospital; 🇩🇰 Aarhus, Denmark