Designed Music Narratives for the Reduction of Side Effects of Chemotherapy in Children (7-12 Years) With Cancer
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
1 other identifier
interventional
68
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable cancer
Started Aug 2014
Longer than P75 for not_applicable cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2014
CompletedFirst Submitted
Initial submission to the registry
February 3, 2015
CompletedFirst Posted
Study publicly available on registry
October 22, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2018
CompletedMay 12, 2016
May 1, 2016
3.8 years
February 3, 2015
May 11, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (13)
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
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
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
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
- +8 more secondary outcomes
Study Arms (2)
Music Narrative Group
EXPERIMENTALPrescribed medical/chemotherapy treatment plus standard care + Designed Music Narratives
Control Group
NO INTERVENTIONPrescribed medical/chemotherapy treatment plus standard care
Interventions
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.
Eligibility Criteria
You may not qualify if:
- Previous and/or acute psychiatric diagnosis
- Cognitive and mental deficits or impaired functioning
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Aarhuslead
- Danish Cancer Societycollaborator
- Børnecancerfondencollaborator
- Ronald McDonalds Børnefondcollaborator
- TrygFonden, Denmarkcollaborator
Study Sites (1)
Aarhus University Hospital
Aarhus, 8200, Denmark
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ilan Sanfi, PhD
Aarhus University Hospistal
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Music therapist, PhD
Study Record Dates
First Submitted
February 3, 2015
First Posted
October 22, 2015
Study Start
August 1, 2014
Primary Completion
June 1, 2018
Study Completion
December 1, 2018
Last Updated
May 12, 2016
Record last verified: 2016-05