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

Not Applicable

• Conditions: Cancer
• Interventions: Behavioral: Guided Imagery and Music

• Registration Number: NCT02583126
• Lead Sponsor: University of Aarhus

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.

Detailed Description

(Will be added later)

Study Timeline

• Study Start: 2014-08
• Study First Submitted: 2015-02-03
• Study First Submitted QC: 2015-10-19
• Study First Posted: 2015-10-22
• Status Verified: 2015-11
• Last Update Submitted: 2015-11-30
• Last Update Posted: 2015-12-02
• Primary Completion: 2017-06
• Study Completion: 2017-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 68

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

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Duration (minutes) of Acute Nausea	Registered the two first evenings within the first 32 hours after onset of chemotherapy during 5th cycle of chemotherapy after enrolment in study	Self-reported duration og nausea in minutes during the first 32 hours after onset of chemotherapy

Secondary Outcome Measures

Name	Time	Method
Satisfaction with music intervention as measured by a Likert-type Scale (participants in music group only)	Last day (i.e. expected 3rd or 4th day) of 5th cycle of chemotherapy after enrolment in study	Self-report, registered once during 5th cycle of chemotherapy
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	Self-reported intensity of nausea, calculated as the average of the two measurements
Number of Days to Absolute Neutrophil Count Recovery defined as ANC ≥ 0.5 x 109/L	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)	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	Registered the two first evenings within the first 32 hours after onset of chemotherapy during 5th cycle of chemotherapy after enrolment in study	Self-reported duration of acute fatigue in minutes within the first 32 hours after onset of chemotherapy
Distress regarding Acute Fatigue as measured by a 5-point Likert-type Scale	Registered the two first evenings within the first 32 hours after onset of chemotherapy during 5th cycle of chemotherapy after enrolment in study	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	Registered the two first evenings within the first 32 hours after onset of chemotherapy during 5th cycle of chemotherapy after enrolment in study	Self-reported appraised food intake, calculated as the average of the two measurements
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	Self-reported numbers of vomiting during the first 32 hours
Weight (kg)	Change between weight from during course 1 and course 5 after inclusion 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	Self-reported distress regarding nausea, calculated as the average of the two measurements
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	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
Duration (minutes) of Acute Pain	Registered the two first evenings within the first 32 hours after onset of chemotherapy during 5th cycle of chemotherapy after enrolment in study	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	Registered the two first evenings within the first 32 hours after onset of chemotherapy during 5th cycle of chemotherapy after enrolment in study	Self-reported intensity of pain, calculated as the average of the two measurements
Sense of Coherence as measured by the Antonovsky Sense of Coherence Scale	Last day (i.e. expected 3rd or 4th day) of 5th cycle of chemotherapy after enrolment in study	Self-report, registered once during 5th cycle of chemotherapy

Trial Locations

Locations (1)

Aarhus University Hospital; 🇩🇰 Aarhus, Denmark