Guided Imagery and Music for the Reduction of Side Effects of Chemotherapy in Teenagers

University of Aarhus

Status: Unknown

Conditions: Cancer

Treatments: Behavioral: Guided Imagery and Music

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02583126

GIM-Cancer-Teenagers-1

Details and patient eligibility

About

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.

Full description

(Will be added later)

Enrollment: 68 estimated patients

Sex: All

Ages: 12 to 17 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Teenagers at the ages 12-17

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

1. Previous and/or acute psychiatric diagnosis
2. Cognitive and mental deficits or impaired functioning

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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68 participants in 2 patient groups

Music Group

Experimental group

Description:

Prescribed medical/chemotherapy treatment plus standard care + Guided Imagery and Music

Treatment:

Behavioral: Guided Imagery and Music

Control Group

No Intervention group

Description:

Prescribed medical/chemotherapy treatment plus standard care