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

University of Aarhus1 site in 1 country68 target enrollmentAugust 2014

ConditionsCancer

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Cancer
Sponsor: University of Aarhus
Enrollment: 68
Locations: 1
Primary Endpoint: Duration (minutes) of Acute Nausea
Last Updated: 10 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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)

Registry

clinicaltrials.gov

Start Date

August 2014

End Date

December 2017

Last Updated

10 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

University of Aarhus

Responsible Party

Principal Investigator

Ilan Sanfi

Music therapist, PhD

Aarhus University Hospital

Eligibility Criteria

Inclusion Criteria

•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

Exclusion Criteria

•Previous and/or acute psychiatric diagnosis
•Cognitive and mental deficits or impaired functioning

Outcomes

Primary Outcomes

Duration (minutes) of Acute Nausea

Time Frame: 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 Outcomes

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)
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)
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))
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)
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)
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)
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)
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)
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)
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)
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)
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)