The Effect of Walking Intervention on Sleep Related Symptom Distress in Pediatric Oncology Patients
试验速览
- 阶段
- 不适用
- 入组人数
- 55
- 试验地点
- 2
- 主要终点
- Sleep quality
研究概览
简要总结
Specific aims:
Control group(2010/1~2011/6): Aim 1: Describe the patterns of "fatigue, sleep disturbance, and pain" in children with cancer from perspectives of children and their parents over the course of one cycle (five days) of inpatient chemotherapy (CXT).
Aim 2: Determine, at various time points (during they are hospitalization various four times), the associations between fatigue, sleep disturbance, and pain over the course of four cycles (there are five days in each cycle) of CTX in children with cancer.
Aim 3: Examine the associations between a symptom cluster of fatigue, sleep disturbance, pain, child reported Quality of Life for Children with Cancer (QOLCC), parent reported uncertainty and QOL, and biomarkers over the course of four cycles of CXT in children with cancer.
Intervention group(2011/7~2012/12): Aim 4: To test an intervention program (two 20-minute sessions of walking around the nurse's station daily, five days a cycle) to reduce the symptoms of fatigue and pain and increase quality of sleep.
详细描述
※ Background & Significance: Symptom management is a major issue for pediatric oncology patients and their parents. In clinical practice patients undergoing cancer treatment seldom present with a single symptom, but usually suffer from multiple symptoms simultaneously. However, when discussing symptom distress in children with cancer, studies have mostly focused on one (single) symptom. Fatigue and pain are two of the most frequent symptoms generated by cancer treatment and they attribute this to their altered sleep pattern. The new concept of the clustering of fatigue, sleep and pain needs additional research to strengthen this beginning scientific base. At this point limited empirical studies have provided evidence or foundational knowledge of the symptom clusters experienced by children with cancer, thus this is a new area and knowledge should be developed as soon as possible for management. Innovative interventions aimed at improving their physical functions such as sleep, fatigue, and pain and adherence to positive health behaviors such as regular walking are warranted. In addition, one parent of eligible children newly diagnosed with cancer will be recruited to examine their quality of life and perception of uncertainty in illness.
※ Specific aims: Control group(2010/1~2011/6): Aim 1: Describe the patterns of "fatigue, sleep disturbance, and pain" in children with cancer from perspectives of children and their parents over the course of one cycle (five days) of inpatient chemotherapy (CXT).
Aim 2: Determine, at various time points(during they are hospitalization various four times), the associations between fatigue, sleep disturbance, and pain over the course of four cycles (there are five days in each cycle) of CTX in children with cancer.
Aim 3: Examine the associations between a symptom cluster of fatigue, sleep disturbance, pain, child reported Quality of Life for Children with Cancer (QOLCC), parent reported uncertainty and QOL, and biomarkers over the course of four cycles of CXT in children with cancer.
Intervention group(2011/7~2012/12): Aim 4: To test an intervention program (two 20-minute sessions of walking around the nurse's station daily, five days a cycle) to reduce the symptoms of fatigue and pain and increase quality of sleep.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 10 Years 至 18 Years(Child, Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •are aged 10 to 18 years
- •diagnosed with cancer
- •prescribed CTX
- •are not receiving concomitant radiation
- •have not undergone bone marrow transplantation.
排除标准
- •patients with central nervous system tumors will be ineligible because sleep problems have been associated with brain injury.
- •besides, patients with osteosarcoma and bone metastasis will not be recruited because they may have troubles with walking.
结局指标
主要结局
Sleep quality
时间窗: During subjects are hospitalization various four times, and there are five days in each period
The investigators measure the outcome by actigraph and questionnaire.
次要结局
未报告次要终点
研究者
National Taiwan University Hospital
Associate Professor
National Taiwan University Hospital
