NCT02583126Unknown不适用
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
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 68
- 试验地点
- 2
- 主要终点
- Duration (minutes) of Acute Nausea
研究概览
简要总结
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.
详细描述
(Will be added later)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 12 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
- •Idarubicin
- •Ifosfamide
- •Mitoxantrone
- •Methotrexate >1000 mg/m2
- •Highly emetogenic chemotherapy:
- •Cisplatin >25 mg/m2
- •Cyclophosphamide >1500 mg/m2
- •Dacarbazine
- •Understand Norwegian/Danish
- •Read Norwegian/Danish (teenagers or alternatively parents)
- •No significant hearing impairment
- •Informed written consent (teenagers ≥16 years and parents)
- •Subsequent verbal confirmation of written informed consent before enrolment in study
排除标准
- •Previous and/or acute psychiatric diagnosis
- •Cognitive and mental deficits or impaired functioning
结局指标
主要结局
Duration (minutes) of Acute Nausea
时间窗: 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
次要结局
- 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)
研究者
Ilan Sanfi
Music therapist, PhD
Aarhus University Hospital
研究点 (2)
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