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CTRI Number  CTRI/2019/01/017111 [Registered on: 16/01/2019] Trial Registered Prospectively
Last Modified On: 31/05/2019
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   A study to know about the level of knowledge on Breast cancer, knowledge and practice of breast cancer prevention strategies like screening among women in Udupi district 
Scientific Title of Study   Awareness and practice of Breast cancer screening among women in Udupi district 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Kunjaru Sneha 
Designation  Post Graduate Student- MPH 3rd semester 
Affiliation  Prasanna School of Public Health, Manipal Academy of Higher Education, Manipal 
Address  Prasanna School of Public Health, Manipal Academy of Higher Education, Manipal

Udupi
KARNATAKA
576104
India 
Phone  7760552608  
Fax    
Email  sneha3399@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Prakash Narayanan 
Designation  Associate professor 
Affiliation  Prasanna School of Public Health, Manipal Academy of Higher Education, Manipal 
Address  Prasanna School of Public Health, Manipal Academy of Higher Education, Manipal, Karnataka

Udupi
KARNATAKA
576104
India 
Phone  9686570750  
Fax    
Email  prakash.nvp@manipal.edu  
 
Details of Contact Person
Public Query  
Name  Dr Kunjaru Sneha 
Designation  Post Graduate Student- MPH 3rd semester 
Affiliation  Prasanna School of Public Health, Manipal Academy of Higher Education, Manipal 
Address  Prasanna School of Public Health, Manipal Academy of Higher Education, Manipal

Udupi
KARNATAKA
576104
India 
Phone  7760552608  
Fax    
Email  sneha3399@gmail.com  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  Dr Kunjaru Sneha 
Address  Prasanna School of Public Health, Manipal Academy of Higher Education, Manipal 
Type of Sponsor  Other [Self sponsored] 
 
Details of Secondary Sponsor  
Name  Address 
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 Kunjaru Sneha  Udupi, Kaup and Karkala taluks of Udupi district  Households in Udupi, Kaup and Karkala taluks of Udupi district
Udupi
KARNATAKA 		 7760552608

sneha3399@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Women in age group of 20-60 years and those who are willing to participate 
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  60.00 Year(s)
Gender  Female 
Details  Women in the age group of 20-60 years and those who are willing to participate 
 
ExclusionCriteria 
Details  Women in that age group who are diagnosed with Breast cancer 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Reveals the level of knowledge on Breast cancer and knowledge and practice of Breast cancer screening methods among women in Udupi district   Last week of April 
 
Secondary Outcome  
Outcome  TimePoints 
Reveals the level of knowledge on Breast cancer and knowledge and practice of Breast cancer screening methods among women in Udupi district   Last week of April 
 
Target Sample Size   Total Sample Size="400"
Sample Size from India="400" 
Final Enrollment numbers achieved (Total)= "362"
Final Enrollment numbers achieved (India)="362" 
Phase of Trial   N/A 
Date of First Enrollment (India)   21/01/2019 
Date of Study Completion (India) 15/03/2019 
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)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   None yet 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

Aims & objectives:

To assess awareness of Breast cancer symptoms among adult women

To study the knowledge and practice of Breast cancer screening

To find out the association between the socio-demographic variables, knowledge on breast cancer and breast cancer screening practices.

Summary:
This purpose of this study is to assess the knowledge regarding the symptoms, risk factors of breast cancer and awareness, practice of Breast cancer screening methods among women in Udupi district. Women in the age group of 20-60 years and those who are willing to participate are included and women suffering from Breast cancer are excluded from the study. The total sample size is 400. Women residing in Udupi, Karkala and Kaup taluk of Udupi district are interviewed with the help of pre-validated questionnaire by the principal investigator about the knowledge on breast cancer symptoms, risk factors and knowledge and practice of breast cancer screening methods. From the Udupi, Karkala and Kaup taluks of Udupi district the villages(rural parts) and wards(urban parts)  are selected according to population proportionate and among each village and ward 10 households are selected randomly. The eligible participant(women) is interviewed with the help of pre-validated questionnaire which includes knowledge on breast cancer and knowledge and practice of various screening methods of breast cancer. The collected information is kept confidential. 
 
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