Health Condition 1: C00-D49- Neoplasms
Conditions
Interventions
None listed
Sponsors
Prof Sameer Bakhshi
Eligibility
Inclusion criteria
Inclusion criteria: 1. Age between 4 years to 2. Patients with a history of pathologically confirmed malignancies. 3. Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2. 4. Both the child and their guardian understand Hindi. 5. For inclusion in group 1, pretesting, or pilot testing: Pediatric cancer patients currently undergoing highly-emetogenic or moderately emetogenic chemotherapy. 6. 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. 7. For inclusion in group 3: Cancer survivors, currently not on any form of therapy.
Exclusion criteria
Exclusion criteria: 1. Any physical or cognitive impairments that preclude the use of PeNAT, such as blindness or mental retardation. 2. Any history of CNS disease including brain metastasis, seizure disorder, developmental disorder, or psychosis 3. For patients in group 2, any patient having gastrointestinal ailments such as neutropenic colitis at the time of testing will be excluded. 4. Not willing to participate in the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. The test-retest reliability coefficient between the first and second paired PeNAT-Hindi scores in group 1 2. The mean difference between the PeNAT-Hindi scores in groups 1 and 2/3 3. The correlation coefficient between the PeNAT-Hindi nausea scores and the number of episodes of vomiting/ retching 4. The correlation coefficient between the childrenâ??s PeNAT-Hindi nausea scores and the numeric rating scale (NRS) scores for nausea as assessed by the parents Timepoint: 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 patientâ??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. | — |
Secondary
| Measure | Time frame |
|---|---|
| The correlation coefficient between the childrenâ??s PeNAT-Hindi nausea scores and the Numeric Pain Rating Scale (NPRS) scores for pain as assessed by the parents. Timepoint: At the time of the first PeNAT assessment within 4-24 hours of chemotherapy.;The responsiveness of the PeNAT-Hindi tool to changes in the severity of nausea over time.Timepoint: 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. | — |
Countries
India
Contacts
Public ContactSameer Bakhshi
All India Institute of Medical Sciences, New Delhi
Outcome results
None listed