Palliative Intervention to Improve Quality of Life in Children With Cancer: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Quality of life cancer child
研究概览
简要总结
A randomized controlled trial to compare the quality of life between participants who were given palliative care (a 3-month home visit) and those who were not (intervention vs control group) was conducted. Participants consisted of children with cancer aged 2-18 years old. A two-way communication between a trained health worker and participants with or without their parents were conducted as the intervention (report by proxy or self-report). Interventions were given in 6 sessions (1 session every 2 weeks) focusing on problems solving education, symptoms management, self-care, communication, decision making, and long-term care plan assistance. In the first and twelfth week of the intervention, all participants were assessed with the Pediatric Quality of Life Inventory (PedsQLTM) questionnaire cancer module 3.0. Symptomps intensityof anorexia, sleep diturbance, and pain will be asessed in each visit. Participants were followed, Emergency Room (ER) admissions were recorded during follow up period. During the follow up period, ER admissions were recorded further.
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
- 2 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Child age 2-18 years old with malignancies who undergo treatments at the Department of Child Health of Cipto Mangunkusumo Hospital, during the study period.
- •All participants who meet the criteria to get palliative care, participants with a total score ≥ 4 based on palliative screening form.
- •Participants and or parents agree to be enrolled in study
排除标准
- •Patients who live outside Jakarta and therefore unreachable to get palliative intervention
结局指标
主要结局
Quality of life cancer child
时间窗: at the end of 3 months follow up
Measured using PedsQLTM cancer module 3.0 that consisted of eight dimension. Each dimension consisted of several items to be answered. Item scaling was answered in 5-point Likert scale from 0 (Never) to 4 (Almost always). Scores are transformed to a 0 to 100 scale. Items are reversed scored and linearly transformed to a 0-100 scale as follows: 0=100, 1=75, 2=50, 3=25, 4=0. If more than 50% of the items in the scale are missing, the scale scores should not be computed. Mean score = Sum of the items over the number of items answered. Total score is acquired by summing of all the items over the number of items answered on all the Scales.Higher scores indicate lower problems.
次要结局
- Emergency room visits(during 3 months follow up)
- Symptomps intensity(during 3 months follow up)
研究者
Murti Andriastuti, Doctor
Principal Investigator
Indonesia University