“Translation and Validation of the Hindi version of the Pediatric Nausea Assessment Tool (PeNAT) in the Indian Populationâ€
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- 1. The test-retest reliability coefficient between the first and second paired PeNAT-Hindi scores in group 1
研究概览
简要总结
Chemotherapy-inducednausea and vomiting (CINV) is one of the most common side-effects in patientsof all ages treated with chemotherapy. Over the years, a fewtools have been developed for the measurement of nausea in general in thepediatric population, as well as chemotherapy-induced nausea, but none have been validated in the Indian population. The primary objective of this study is the translation/adaptation and validation of the pediatric nausea assessment (PeNAT) tool for use in the Hindi-speakingpediatric population in India. The PeNAT tool,developed by LL Dupuis, is available in the public domain and is free to use. Usingthe PeNAT involves three steps, the first of which is determining what word isused for nausea in each child’s family. Subsequently, the child is taught howto use the PeNAT tool and how to express the severity of their nausea bychoosing an appropriate face from a choice of four faces used in the PeNATscale. The PeNAT tool was validated on a population of children receivingchemotherapy and is hence of particular interest for use in research involvinganti-emetic regimens in the pediatric cancer population. The PeNAT tool hasalready been translated/ validated in French and Spanish.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 4.00 Year(s) 至 18.00 Year(s)（—）
- 性别
- All
入选标准
- •Age between 4 years to ≤18 years, and willing to participate in the study.
- •Patients with a history of pathologically confirmed malignancies.
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or
- •Both the child and their guardian understand Hindi.
- •For inclusion in group 1, pretesting, or pilot testing: Pediatric cancer patients currently undergoing highly-emetogenic or moderately emetogenic chemotherapy.
- •For inclusion in group 2, pretesting, or pilot testing: Pediatric cancer patients currently on treatment, but not having received chemotherapy within the past five days.
- •For inclusion in group 3: Cancer survivors, currently not on any form of therapy.
排除标准
- •Any physical or cognitive impairments that preclude the use of PeNAT, such as blindness or mental retardation.
- •For patients in group 2, any patient having gastrointestinal ailments such as neutropenic colitis at the time of testing will be excluded.
- •Not willing to participate in the study.
结局指标
主要结局
1. The test-retest reliability coefficient between the first and second paired PeNAT-Hindi scores in group 1
时间窗: 1. For patients in group 1, first and second PeNAT scoring will be done within 4-24 hours of chemotherapy, 1 hour apart. Just prior to the first PeNAT assessment, the parent or guardian will be asked to assess the severity of the patient’s nausea. | 2. Number of episodes of vomiting or retching for 4 hours before the first test and between the two tests. | 3. In groups 2 and 3, the children will be administered the PeNAT-Hindi instrument once at any time during a routine OPD visit.
2. The mean difference between the PeNAT-Hindi scores in groups 1 and 2/3
时间窗: 1. For patients in group 1, first and second PeNAT scoring will be done within 4-24 hours of chemotherapy, 1 hour apart. Just prior to the first PeNAT assessment, the parent or guardian will be asked to assess the severity of the patient’s nausea. | 2. Number of episodes of vomiting or retching for 4 hours before the first test and between the two tests. | 3. In groups 2 and 3, the children will be administered the PeNAT-Hindi instrument once at any time during a routine OPD visit.
3. The correlation coefficient between the PeNAT-Hindi nausea scores and the number of episodes of vomiting/ retching
时间窗: 1. For patients in group 1, first and second PeNAT scoring will be done within 4-24 hours of chemotherapy, 1 hour apart. Just prior to the first PeNAT assessment, the parent or guardian will be asked to assess the severity of the patient’s nausea. | 2. Number of episodes of vomiting or retching for 4 hours before the first test and between the two tests. | 3. In groups 2 and 3, the children will be administered the PeNAT-Hindi instrument once at any time during a routine OPD visit.
4. The correlation coefficient between the children’s PeNAT-Hindi nausea scores and the numeric rating scale (NRS) scores for nausea as assessed by the parents
时间窗: 1. For patients in group 1, first and second PeNAT scoring will be done within 4-24 hours of chemotherapy, 1 hour apart. Just prior to the first PeNAT assessment, the parent or guardian will be asked to assess the severity of the patient’s nausea. | 2. Number of episodes of vomiting or retching for 4 hours before the first test and between the two tests. | 3. In groups 2 and 3, the children will be administered the PeNAT-Hindi instrument once at any time during a routine OPD visit.
次要结局
- The correlation coefficient between the children’s PeNAT-Hindi nausea scores and the Numeric Pain Rating Scale (NPRS) scores for pain as assessed by the parents.
- The responsiveness of the PeNAT-Hindi tool to changes in the severity of nausea over time.(All patients in group 1 will continue to assess their nausea till 24 hours after the last dose of chemotherapy in their cycle. These scores will be compared with the initial scores for responsiveness testing.)