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CTRI Number  CTRI/2024/05/068147 [Registered on: 31/05/2024] Trial Registered Prospectively
Last Modified On: 30/05/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Behavioral 
Study Design  Single Arm Study 
Public Title of Study   Health Education regarding Cervical, Breast and Oral cancer among ASHA Workers 
Scientific Title of Study   Impact of Health Education on Screening of Cervical, Breast and Oral cancer among Peripheral Health Workers of district Etawah:An Interventional Study 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Shobhit Singh 
Designation  Postgraduate resident doctor 
Affiliation  Uttar pradesh university of medical sciences 
Address  Department of Community medicine Room 205
UPUMS Saifai Etawah Uttar pradesh 206130
Etawah
UTTAR PRADESH
206130
India 
Phone  9808583248  
Fax    
Email  singhdrshobhit@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Mohit Mishra 
Designation  Professor 
Affiliation  Uttar pradesh university of medical sciences 
Address  Department of Community Medicine uttar pradesh university of medical sciences saifai
Etawah Uttar pradesh
Etawah
UTTAR PRADESH
206130
India 
Phone  7007023674  
Fax    
Email  mohi.mish@gmail.com  
 
Details of Contact Person
Public Query  
Name  Shobhit singh 
Designation  Postgraduate resident doctor 
Affiliation  Uttar pradesh university of medical sciences 
Address  Department of Community Medicine Room 205
UPUMS Saifai Etawah Uttar pradesh 206130
Etawah
UTTAR PRADESH
206130
India 
Phone  9808583248  
Fax    
Email  singhdrshobhit@gmail.com  
 
Source of Monetary or Material Support  
Department of Community Medicine Uttar pradesh university of medical sciences Saifai Etawah 206130 uttar pradesh India 
 
Primary Sponsor  
Name  Dr Shobhit Singh 
Address  Department of Community Medicine upums saifai Etawah 206130 
Type of Sponsor  Other [Dr Shobhit Singh] 
 
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 Shobhit Singh  Dr Shobhit Singh  Uttar pradesh university of medical sciences
Etawah
UTTAR PRADESH 		 9808583248

singhdrshobhit@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Uttar pradesh University of Medical Sciences Ethics committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Peripheral health workers between 25 to 45 years 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Health education  Health education regarding knowledge of cervical, breast and oral cancer will be given for duration 0f 15 days 
Comparator Agent  not applicable  not applicable as single arm trial 
 
Inclusion Criteria  
Age From  25.00 Year(s)
Age To  45.00 Year(s)
Gender  Both 
Details  1.Peripheral health workers who are currently working at CHC
2.Peripheral health workers who are residing in rural or urban areas
of etawah district
3.Peripheral health workers who will provide
consent 
 
ExclusionCriteria 
Details  1.Peripheral health workers who will not be available for at least 2
visits for data collection.
2.Peripheral health workers who have been already diagnosed for cervical, breast and oral cancer 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To assess the knowledge change regarding screening of cervical cancer, breast cancer and oral cancer among peripheral health workers of
district Etawah 		 3 months after intervention 
 
Secondary Outcome  
Outcome  TimePoints 
Increase in knowledge about cervical cancer  3 months after intervention 
Increase in knowledge about breast cancer  3 months after intervention 
Increase in knowledge about oral cancer  3 months after intervention 
 
Target Sample Size   Total Sample Size="300"
Sample Size from India="300" 
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   Phase 2/ Phase 3 
Date of First Enrollment (India)   10/06/2024 
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="4"
Days="10" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
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  
The interventional study(without control) is to assess is the impact of educational intervention on awareness level of Cervical, breast and oral cancer and acceptance for screening among peripheral health worker of Etawah. Study will comprise of pre-designed pre-tested, Semi-structured questionnaire for the data collection of the variables to elicit the information regarding socio-demographic profile of the study participants. It will include name, age, gender, religion, caste, educational status, monthly income (socio-economic status), Duration of Service (years), marital status, health status etc. questionnaire will be used to assess knowledge about Awareness of cancer (cervical, breast and oral), Risk factors, symptoms and means of prevention of cancer, perception about cancer screening.
 
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