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

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.

Study Overview

• Status: Unknown
• Conditions: Cancer
• Intervention / Treatment: Behavioral: Guided Imagery and Music

Detailed Description

(Will be added later)

• Study Type: Interventional
• Enrollment (Anticipated): 68
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Aarhus, Denmark, 8200
    • Recruiting
    • Aarhus University Hospital
    • Contact: Lisbeth Rasmussen; Phone Number: +45 78 45 14 70; Email: lisbeth.rasmussen@skejby.rm.dk
    • Sub-Investigator: Henrik Hasle, Prof. PhD MD
    • Principal Investigator: Ilan Sanfi, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 17 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control Group; Prescribed medical/chemotherapy treatment plus standard care
Experimental: Music Group; Prescribed medical/chemotherapy treatment plus standard care + Guided Imagery and Music	Behavioral: Guided Imagery and Music; Modified and resource-oriented form of the Bonny Method of Guided Imagery and Music (BM-GIM); Other Names: Music and imagery, music therapy, active music listening

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of Aarhus
• Collaborators: Danish Cancer Society; TrygFonden, Denmark; Børnecancerfonden; Ronald McDonalds Børnefond
• Investigators: Principal Investigator: Ilan Sanfi, PhD, Aarhus University Hospital

Publications and helpful links

General Publications

• 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:CD006911. doi: 10.1002/14651858.CD006911.pub4. Review.

Study record dates

Study Major Dates

• Study Start: August 1, 2014
• Primary Completion (Anticipated): June 1, 2017
• Study Completion (Anticipated): December 1, 2017

Study Registration Dates

• First Submitted: February 3, 2015
• First Submitted That Met QC Criteria: October 19, 2015
• First Posted (Estimate): October 22, 2015

Study Record Updates

• Last Update Posted (Estimate): December 2, 2015
• Last Update Submitted That Met QC Criteria: November 30, 2015
• Last Verified: November 1, 2015

More Information

Terms related to this study

• Keywords: Teenager; moderate and/or highly emetogenic chemotherapy
• Other Study ID Numbers: GIM-Cancer-Teenagers-1