Guided Imagery and Music for the Reduction of Side Effects of Chemotherapy in Teenagers
The Effect and Meaning of a Designed Guided Imagery and Music Intervention on Anticipatory, Acute, and Delayed Side Effect of Chemotherapy in Teenagers 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 modified and resource-oriented form of Guided Imagery and Music (GIM) is effective in reducing side effects of chemotherapy in teenagers 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
Typical duration 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, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2017
CompletedDecember 2, 2015
November 1, 2015
2.8 years
February 3, 2015
November 30, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Duration (minutes) of Acute Nausea
Self-reported duration og nausea in minutes during 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
Secondary Outcomes (14)
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
- +9 more secondary outcomes
Study Arms (2)
Music Group
EXPERIMENTALPrescribed medical/chemotherapy treatment plus standard care + Guided Imagery and Music
Control Group
NO INTERVENTIONPrescribed medical/chemotherapy treatment plus standard care
Interventions
Modified and resource-oriented form of the Bonny Method of Guided Imagery and Music (BM-GIM)
Eligibility Criteria
You may qualify if:
- Teenagers at the ages 12-17
- 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:
- +8 more 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
Related Publications (1)
Bradt J, Dileo C, Myers-Coffman K, Biondo J. Music interventions for improving psychological and physical outcomes in people with cancer. Cochrane Database Syst Rev. 2021 Oct 12;10(10):CD006911. doi: 10.1002/14651858.CD006911.pub4.
PMID: 34637527DERIVED
MeSH Terms
Conditions
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ilan Sanfi, PhD
Aarhus University Hospital
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, 2017
Study Completion
December 1, 2017
Last Updated
December 2, 2015
Record last verified: 2015-11