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

Primary Purpose

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

Status
Unknown status
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Designed Music Narratives
Sponsored by
University of Aarhus
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Cancer focused on measuring Children, Moderate and/or highly emetogenic chemotherapy

Eligibility Criteria

7 Years - 12 Years (Child)All SexesDoes not accept healthy volunteers
  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

Sites / Locations

  • Aarhus University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Music Narrative Group

Control Group

Arm Description

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

Prescribed medical/chemotherapy treatment plus standard care

Outcomes

Primary Outcome Measures

Duration (minutes) of Acute Nausea
Self-reported duration og nausea in minutes within the first 32 hours after onset of chemothera

Secondary Outcome Measures

Intensity of Acute Nausea as measured by the Visual Analogue Scale
Self-reported intensity of nausea, calculated as the average of the two measurements
Distress regarding Acute Nausea as measured by the Visual Analogue Scale
Self-reported distress regarding nausea, calculated as the average of the two measurements
Amount (mg/m2) of Nausea Reducing Medicine Consumed
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
Numbers of Acute Vomiting
Self-reported numbers of vomiting during the first 32 hours
Duration (minutes) of Acute Pain
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
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
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
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
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
Self-reported appraised food intake, calculated as the average of the two measurements
Weight (kg)
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

Full Information

First Posted
February 3, 2015
Last Updated
May 11, 2016
Sponsor
University of Aarhus
Collaborators
Danish Cancer Society, Børnecancerfonden, Ronald McDonalds Børnefond, TrygFonden, Denmark
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1. Study Identification

Unique Protocol Identification Number
NCT02583139
Brief Title
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

2. Study Status

Record Verification Date
May 2016
Overall Recruitment Status
Unknown status
Study Start Date
August 2014 (undefined)
Primary Completion Date
June 2018 (Anticipated)
Study Completion Date
December 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Aarhus
Collaborators
Danish Cancer Society, Børnecancerfonden, Ronald McDonalds Børnefond, TrygFonden, Denmark

4. Oversight

Data Monitoring Committee
No

5. Study Description

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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer, Chemotherapy-induced Nausea and Vomiting, Effects of Chemotherapy
Keywords
Children, Moderate and/or highly emetogenic chemotherapy

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
68 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Music Narrative Group
Arm Type
Experimental
Arm Description
Prescribed medical/chemotherapy treatment plus standard care + Designed Music Narratives
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
Prescribed medical/chemotherapy treatment plus standard care
Intervention Type
Behavioral
Intervention Name(s)
Designed Music Narratives
Intervention Description
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.
Primary Outcome Measure Information:
Title
Duration (minutes) of Acute Nausea
Description
Self-reported duration og nausea in minutes within the first 32 hours after onset of chemothera
Time Frame
Registered the two first evenings within the first 32 hours after onset of chemotherapy during 5th cycle of chemotherapy after enrolment in study
Secondary Outcome Measure Information:
Title
Intensity of Acute Nausea as measured by the Visual Analogue Scale
Description
Self-reported intensity of nausea, calculated as the average of the two measurements
Time Frame
Registered the two first evenings within the first 32 hours after onset of chemotherapy during 5th cycle of chemotherapy after enrolment in study
Title
Distress regarding Acute Nausea as measured by the Visual Analogue Scale
Description
Self-reported distress regarding nausea, calculated as the average of the two measurements
Time Frame
Registered the two first evenings within the first 32 hours after onset of chemotherapy during 5th cycle of chemotherapy after enrolment in study
Title
Amount (mg/m2) of Nausea Reducing Medicine Consumed
Time Frame
During admission (an expected average of 3 days) and the first three days after discharge regarding 5th cycle of chemotherapy after enrolment in study
Title
Multiple Acute Side Effects of Chemotherapy as measured by the Memorial Symptom Assessment Scale
Description
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
Time Frame
Registered the two first evenings within the first 32 hours after onset of chemotherapy during 5th cycle of chemotherapy after enrolment in study
Title
Numbers of Acute Vomiting
Description
Self-reported numbers of vomiting during the first 32 hours
Time Frame
Registered the two first evenings within the first 32 hours after onset of chemotherapy during 5th cycle of chemotherapy after enrolment in study
Title
Duration (minutes) of Acute Pain
Description
Self-reported duration of acute pain in minutes within the first 32 hours after onset of chemotherapy
Time Frame
Registered the two first evenings within the first 32 hours after onset of chemotherapy during 5th cycle of chemotherapy after enrolment in study
Title
Acute Pain Intensity as measured by the Visual Analogue Scale
Description
Self-reported intensity of pain, calculated as the average of the two measurements
Time Frame
Registered the two first evenings within the first 32 hours after onset of chemotherapy during 5th cycle of chemotherapy after enrolment in study
Title
Number of Days to Absolute Neutrophil Count Recovery (ANCR) defined as ANCR ≥ 0.5 x 109/L
Description
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 Frame
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)
Title
Duration (minutes) of Acute Fatigue
Description
Self-reported duration of acute fatigue in minutes within the first 32 hours after onset of chemotherapy
Time Frame
Registered the two first evenings within the first 32 hours after onset of chemotherapy during 5th cycle of chemotherapy after enrolment in study
Title
Distress of Acute Fatigue as measured by a 5-point Likert-type Scale
Description
Self-reported Distress regarding Acute Fatigue, calculated as the average of the two measurements
Time Frame
Registered the two first evenings within the first 32 hours after onset of chemotherapy during 5th cycle of chemotherapy after enrolment in study
Title
Appraised Food Intake and Appetite as measured by a 5-point Likert-type Scale
Description
Self-reported appraised food intake, calculated as the average of the two measurements
Time Frame
Registered the two first evenings within the first 32 hours after onset of chemotherapy during 5th cycle of chemotherapy after enrolment in study
Title
Weight (kg)
Time Frame
Change between weight from during course 1 and course 5 after inclusion in study
Title
Satisfaction with Applied Music Intervention as measured by a Likert-type Scale (participants in music group only)
Description
Self-report, registered once during 5th cycle of chemotherapy
Time Frame
Last day (i.e. expected 3rd or 4th day) of 5th cycle of chemotherapy after enrolment in study

10. Eligibility

Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Children at the ages 7-12 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 Understand Norwegian/Danish 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ilan Sanfi, PhD
Phone
+4522973661
Email
ilan@sanfi.dk
First Name & Middle Initial & Last Name or Official Title & Degree
Stine C. Ærø, BA
Phone
+47 92498316
Email
sero@ous-hf.no
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ilan Sanfi, PhD
Organizational Affiliation
Aarhus University Hospistal
Official's Role
Principal Investigator
Facility Information:
Facility Name
Aarhus University Hospital
City
Aarhus
ZIP/Postal Code
8200
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lisbeth Rasmussen
Phone
+45 78 45 14 70
Email
lisbeth.rasmussen@skejby.rm.dk
First Name & Middle Initial & Last Name & Degree
Henrik Hasle, Prof. PhD MD

12. IPD Sharing Statement

Learn more about this trial

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

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