Guided Imagery and Music for the Reduction of Side Effects of Chemotherapy in Teenagers
NCT ID: NCT02583126
Last Updated: 2015-12-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
68 participants
INTERVENTIONAL
2014-08-31
2017-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Music Group
Prescribed medical/chemotherapy treatment plus standard care + Guided Imagery and Music
Guided Imagery and Music
Modified and resource-oriented form of the Bonny Method of Guided Imagery and Music (BM-GIM)
Control Group
Prescribed medical/chemotherapy treatment plus standard care
No interventions assigned to this group
Interventions
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Guided Imagery and Music
Modified and resource-oriented form of the Bonny Method of Guided Imagery and Music (BM-GIM)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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. Read Norwegian/Danish (teenagers or alternatively parents)
5. No significant hearing impairment
6. Informed written consent (teenagers ≥16 years and parents)
7. Subsequent verbal confirmation of written informed consent before enrolment in study
Exclusion Criteria
2. Cognitive and mental deficits or impaired functioning
12 Years
17 Years
ALL
No
Sponsors
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Danish Cancer Society
OTHER
Børnecancerfonden
OTHER
Ronald McDonalds Børnefond
OTHER
TrygFonden, Denmark
INDUSTRY
University of Aarhus
OTHER
Responsible Party
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Ilan Sanfi
Music therapist, PhD
Principal Investigators
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Ilan Sanfi, PhD
Role: PRINCIPAL_INVESTIGATOR
Aarhus University Hospital
Locations
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Aarhus University Hospital
Aarhus, , Denmark
Countries
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Central Contacts
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Facility Contacts
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References
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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.
Other Identifiers
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GIM-Cancer-Teenagers-1
Identifier Type: -
Identifier Source: org_study_id