| CTRI Number |
CTRI/2020/10/028271 [Registered on: 07/10/2020] Trial Registered Prospectively |
| Last Modified On: |
25/10/2020 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Validation Study |
| Study Design |
Other |
|
Public Title of Study
|
“Translation and Testing of the PeNAT tool for measuring Nausea in the Hindi-speaking Indian population" |
|
Scientific Title of Study
|
“Translation and Validation of the Hindi version of the Pediatric Nausea Assessment Tool (PeNAT) in the Indian Population†|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| U1111-1257-6371 |
UTN |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sameer Bakhshi |
| Designation |
Professor |
| Affiliation |
All India Institute of Medical Sciences, New Delhi |
| Address |
Dept. of Medical Oncology,
Dr. BRAIRCH
All India Institute of Medical Sciences
AIIMS, Ansari Nagar, New Delhi
South
DELHI
110029
India |
| Phone |
01126588153 |
| Fax |
|
| Email |
sambakh@hotmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Sameer Bakhshi |
| Designation |
Professor |
| Affiliation |
All India Institute of Medical Sciences, New Delhi |
| Address |
Dept. of Medical Oncology,
Dr. BRAIRCH
All India Institute of Medical Sciences
AIIMS, Ansari Nagar, New Delhi
South
DELHI
110029
India |
| Phone |
01126588153 |
| Fax |
|
| Email |
sambakh@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Sameer Bakhshi |
| Designation |
Professor |
| Affiliation |
All India Institute of Medical Sciences, New Delhi |
| Address |
Dept. of Medical Oncology,
Dr. BRAIRCH
All India Institute of Medical Sciences
AIIMS, Ansari Nagar, New Delhi
South
DELHI
110029
India |
| Phone |
01126588153 |
| Fax |
|
| Email |
sambakh@hotmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sciences, New Delhi |
|
|
Primary Sponsor
|
| Name |
Prof Sameer Bakhshi |
| Address |
Dept. of Medical Oncology
BRAIRCH
AIIMS New Delhi 110029 |
| Type of Sponsor |
Other [Principal Investigator] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Prof Sameer Bakhshi |
All India Institute of Medical Sciences |
Dept. of Medical Oncology, Dr. BRA-IRCH, AIIMS, Ansari Nagar 110029
South
DELHI |
011-26588153
sambakh@hotmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee, AIIMS, New Dlehi |
Approved |
| Institute Ethics Committee, AIIMS, New Dlehi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C00-D49||Neoplasms, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
4.00 Year(s) |
| Age To |
18.00 Year(s) |
| Gender |
Both |
| Details |
1. Age between 4 years to ≤18 years, and willing to participate in the study.
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.
|
|
| ExclusionCriteria |
| Details |
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
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
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 children’s PeNAT-Hindi nausea scores and the numeric rating scale (NRS) scores for nausea as assessed by the parents
|
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. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
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.
|
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. |
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. |
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
15/10/2020 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="2"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
Nil. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Chemotherapy-induced
nausea and vomiting (CINV) is one of the most common side-effects in patients
of all ages treated with chemotherapy. Over the years, a few
tools have been developed for the measurement of nausea in general in the
pediatric 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-speaking
pediatric population in India. The PeNAT tool,
developed by LL Dupuis, is available in the public domain and is free to use. Using
the PeNAT involves three steps, the first of which is determining what word is
used for nausea in each child’s family. Subsequently, the child is taught how
to use the PeNAT tool and how to express the severity of their nausea by
choosing an appropriate face from a choice of four faces used in the PeNAT
scale. The PeNAT tool was validated on a population of children receiving
chemotherapy and is hence of particular interest for use in research involving
anti-emetic regimens in the pediatric cancer population. The PeNAT tool has
already been translated/ validated in French and Spanish.
|