FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2024/12/078286 [Registered on: 18/12/2024] Trial Registered Prospectively
Last Modified On: 18/12/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Understanding Health Knowledge in Parents of Children with Cancer.  
Scientific Title of Study   Assessing Health Literacy in Parents of Children Diagnosed with Cancer 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Kota Nithyusha 
Designation  Student 
Affiliation  Prasanna School of Public Hea.lth 
Address  Department of Social and Health Innovation, Prasanna School of Public Health, Manipal Academy of Higher Education, Madhav Nagar, Manipal, Udupi, Karnataka- 576104, India

Udupi
KARNATAKA
576104
India 
Phone  8143838436  
Fax    
Email  nithyusha.psphmpl2023@learner.manipal.edu  
 
Details of Contact Person
Scientific Query  
Name  Dr Usha Rani 
Designation  HOD and Associate professor  
Affiliation  Prasanna School of Public Health 
Address  Prasanna School of Public Health, Manipal Academy of Higher Education, Madhav Nagar, Manipal, Udupi, Karnataka- 576104, India

Udupi
KARNATAKA
576104
India 
Phone  8310214742  
Fax    
Email  usha.rani@manipal.edu  
 
Details of Contact Person
Public Query  
Name  Dr Usha Rani 
Designation  HOD and Associate professor  
Affiliation  Prasanna School of Public Health 
Address  Prasanna School of Public Health, Manipal Academy of Higher Education, Madhav Nagar, Manipal, Udupi, Karnataka- 576104, India


KARNATAKA
576104
India 
Phone  8310214742  
Fax    
Email  usha.rani@manipal.edu  
 
Source of Monetary or Material Support  
Department of Pediatric Hematology and Oncology, Kasturba Hospital, Manipal, Udupi, Karnataka, India - 576104 
Department of Social and Health Innovation, Prasanna School of Public Health, Manipal Academy of Higher Education, Manipal, Udupi, Karnataka, India - 576104 
 
Primary Sponsor  
Name  Kota Nithyusha 
Address  Department of Social and Health Innovation, Prasanna School of Public Health, Manipal Academy of Higher Education, Manipal, Udupi, Karnataka, India - 576104 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Usha Rani  Kasturba Hospital  Department of Pediatric Hematology and Oncology, Women and Children block, Kasturba Hospital, Manipal, Udupi, Karnataka.
Udupi
KARNATAKA 		 8310214742

usha.rani@manipal.edu 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee - 2  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Assessing Health Literacy in Parents of children diagnosed with cancer 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  21.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  Participants are parents who have children who have undergone any malignant
treatment.
The parents of children who are undergoing treatment and have completed treatment. 
 
ExclusionCriteria 
Details  Parents who are not willing to participate in the survey.
Parents who do not give consent are excluded. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
The primary outcomes of the study outcomes are health literacy for promotion and access to healthcare services for the families of children diagnosed with cancer  8 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
The secondary outcome is about the specific challenges faced by the parents of their children who are diagnosed with cancer, like managing the health of the child and the treatment options  8 weeks  
 
Target Sample Size   Total Sample Size="422"
Sample Size from India="422" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" 
Phase of Trial   N/A 
Date of First Enrollment (India)   30/12/2024 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary   Aim: The aim is to assess the health literacy levels among parents of children with cancer.

 Objectives
ʉۢ To identify the factors influencing health literacy among parents.
ʉۢ To examine the impact of health literacy in addressing the issues among parents.

Study Materials:
 Using a demographic questionnaire. A modified MaHeLi scale is used to assess Health Literacy among parents, and author permission has been obtained. 

Study procedure:
The study involves obtaining ethical approvals and permissions for data collection through questionnaire forms. The study design is a cross-sectional analysis conducted on participants eligible for the study, who are parents who have children with cancer and can communicate in English or Kannada. Explaining the study and obtaining informed consent from participants. Data will be collected through questionnaire forms. Data analysis will be done.  The results will be obtained from the analyzed data.

Statistical Methods:
Descriptive and inferential statistics will be used for analysis.
 
Close