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| Name | Class |
|---|---|
| Danish Cancer Society | OTHER |
| Børnecancerfonden | OTHER |
| Ronald McDonalds Børnefond | OTHER |
| TrygFonden, Denmark |
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The purpose of this study is to determine whether a specially-designed music-narratives are effective in reducing side effects of chemotherapy in 7- to 12-year-olds with cancer.
(Will be added later)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Music Narrative Group | Experimental | Prescribed medical/chemotherapy treatment plus standard care + Designed Music Narratives |
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| Control Group | No Intervention | Prescribed medical/chemotherapy treatment plus standard care |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Designed Music Narratives | Behavioral | Four music narratives for children each comprising an introductory relaxation exercise, a resource-oriented narrative including guided imagery suggestions and relaxing nature scenarios plus especially composed music. The narrative and music reflect and support each other. |
| Measure | Description | Time Frame |
|---|---|---|
| Duration (minutes) of Acute Nausea | Self-reported duration og nausea in minutes within the first 32 hours after onset of chemothera | Registered the two first evenings within the first 32 hours after onset of chemotherapy during 5th cycle of chemotherapy after enrolment in study |
| 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 |
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Children at the ages 7-12
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:
Highly emetogenic chemotherapy:
Understand Norwegian/Danish
Parents must be able to read and understand Norwegian/Danish
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ilan Sanfi, PhD | Contact | +4522973661 | ilan@sanfi.dk | |
| Stine C. Ærø, BA | Contact | +47 92498316 | sero@ous-hf.no |
| Name | Affiliation | Role |
|---|---|---|
| Ilan Sanfi, PhD | Aarhus University Hospistal | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aarhus University Hospital | Recruiting | Aarhus | 8200 | Denmark |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D014839 | Vomiting |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| INDUSTRY |
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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 |
| Number of Days to Absolute Neutrophil Count Recovery (ANCR) defined as ANCR ≥ 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) |
| 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 |
| Distress of 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 |
| Weight (kg) | Change between weight from during course 1 and course 5 after inclusion in study |
| Satisfaction with Applied 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 |