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

Cancer Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02583139
• Other study ID #: MF-Cancer-Children-1
• Status: Recruiting
• Phase: N/A
• First received: February 3, 2015
• Last updated: May 11, 2016
• Start date: August 2014
• Est. completion date: December 2018

Study information

• Verified date: May 2016
• Source: University of Aarhus
• Contact: Ilan Sanfi, PhD
• Phone: +4522973661
• Email: ilan[@]sanfi.dk
• Is FDA regulated: No
• Health authority: Denmark: The Regional Committee on Biomedical Research EthicsDenmark: Danish Dataprotection AgencyNorway: Data Protection AuthorityNorway: Regional Ethics Commitee
• Study type: Interventional

Clinical Trial 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.

Description:

(Will be added later)

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 68
• Est. completion date: December 2018
• Est. primary completion date: June 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 7 Years to 12 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Cancer
• Chemotherapy-induced Nausea and Vomiting
• Effects of Chemotherapy

Intervention

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.

Locations

Country	Name	City	State
Denmark	Aarhus University Hospital	Aarhus

Sponsors (5)

Lead Sponsor	Collaborator
University of Aarhus	Børnecancerfonden, Danish Cancer Society, Ronald McDonalds Børnefond, TrygFonden, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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)	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	Weight (kg)		Change between weight from during course 1 and course 5 after inclusion in study	No
Secondary	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	No