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CTRI Number  CTRI/2021/02/031300 [Registered on: 15/02/2021] Trial Registered Prospectively
Last Modified On: 14/02/2021
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Descriptive survey 
Study Design  Other 
Public Title of Study   Risk factors for breast cancer, health beliefs and screening behaviours 
Scientific Title of Study   A study to assess the awareness of risk factors for breast cancer, health beliefs and screening behaviours of working women in selected colleges of Udupi district, Karnataka.  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Gurbinder kaur 
Designation  Post graduate student 
Affiliation  Manipal college of nursing, manipal 
Address  Manipal college of nursing, Manipal Academy of Higher Education, Manipal, Udupi(district), Karnataka.

Udupi
KARNATAKA
576104
India 
Phone  7001743129  
Fax    
Email  ritukaur2513@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Mrs Pratibha 
Designation  Assistant Professor M.sc Nursing (OBG) 
Affiliation  Manipal college of nursing, manipal 
Address  Department of Obstetrics & Gynaecology Nursing Manipal college of nursing, Manipal Academy of Higher Education Manipal Udupi district

Udupi
KARNATAKA
576104
India 
Phone  9964025177  
Fax    
Email  pratibha.prakash@manipal.edu  
 
Details of Contact Person
Public Query  
Name  Mrs Pratibha 
Designation  Assistant professor OBG nursing department 
Affiliation  Manipal college of nursing, manipal 
Address  Department of Obstetrics & Gynaecology Nursing Manipal college of nursing Manipal Academy of Higher Education Manipal Udupi district

Udupi
KARNATAKA
576104
India 
Phone  9964025177  
Fax    
Email  pratibha.prakash@manipal.edu  
 
Source of Monetary or Material Support  
Manipal College of Dental Sciences, Manipal 
Manipal College of Health Professions, Manipal  
Manipal institute of Management, Manipal 
Manipal Institute of Technology, Manipal 
Manipal School of architecture and planning, Manipal 
Welcomgroup Graduate School of Hotel Administration, Manipal 
 
Primary Sponsor  
Name  Gurbinder Kaur SELF 
Address  Manipal college of Nursing, Manipal Academy of Higher Education, Manipal, Karnataka 
Type of Sponsor  Other [self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 6  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Keerthilatha M Pai  Manipal College of Dental Sciences, Manipal  Manipal College of Dental Sciences, Manipal Academy of Higher Education, Manipal - 576104
Udupi
KARNATAKA 		 0820-2922340

keerthilatha.pai@manipal.edu 
Dr G Arun Maiya  Manipal College of Health Professions, Manipal  Manipal College of Health Professions, Manipal Academy of Higher Education, Manipal 576104
Udupi
KARNATAKA 		 0820-2922704

dean.mchp@manipal.edu 
Dr Raveendranath Nayak  Manipal Institute of Management, Manipal  Manipal Institute of Management, Manipal Academy of Higher Education, Manipal - 576104
Udupi
KARNATAKA 		 9164623286

ravi.nayak@manipal.edu 
Dr Ashok Rao  Manipal Institute of Technology  Dean, MIT, Manipal Academy of Higher Education, Manipal- 576104
Udupi
KARNATAKA 		 08202571060

a.rao@manipal.edu 
Dr Deepika Shetty  Manipal School of Architecture and Plannin  MIT Campus, Manipal Academy of Higher Education Manipal 576104
Udupi
KARNATAKA 		 08202924115

office.msap@manipal.edu 
Dr Thirugnanasambantham K  Welcomgroup Graduate School of Hotel Management, Manipal  Welcomgroup Graduate School of Hotel Management, Manipal Academy of Higher Education, Manipal576194
Udupi
KARNATAKA 		 9343163237

meenakshi.garg@manipal.edu 
 
Details of Ethics Committee  
No of Ethics Committees= 7  
Name of Committee  Approval Status 
Institutional ethics committee  Approved 
Permission letter from Institute 1  Approved 
Permission letter from Institute 2  Approved 
Permission letter from Institute 3  Approved 
Permission letter from Institute 4  Approved 
Permission letter from Institute 5  Approved 
Permission letter from Institute 6  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Healthy  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  30.00 Year(s)
Age To  60.00 Year(s)
Gender  Female 
Details  1. Working women between the age group of 30-60 years
2. Who are available during the period of data collection
3. Who are ready to participate in the study.
 
 
ExclusionCriteria 
Details   
 
Method of Generating Random Sequence   Random Number Table 
Method of Concealment    
Blinding/Masking    
Primary Outcome  
Outcome  TimePoints 
Percentage of awareness of risk factors   1 year 
 
Secondary Outcome  
Outcome  TimePoints 
Health beliefs and screening behaviors Scores  1 year 
 
Target Sample Size   Total Sample Size="271"
Sample Size from India="271" 
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)   15/02/2021 
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="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

The findings of the study will help in improving awareness among women concerning breast cancer and its screening. Identifying health beliefs will help in planning the best possible preventive strategies for individual and community. This will further aid in providing adequate information and plan interventions for early detection of the danger signs by women themselves hence reducing the mortality and morbidity rates. The findings will further contribute in planning effective strategies aimed at minimizing the perceived barriers towards breast cancer screening and thus enhancing the preventive and screening behaviours and improving overall women health.

The findings of the study will help in improving awareness among women concerning breast cancer and its screening. Identifying health beliefs will help in planning the best possible preventive strategies for individual and community.

 
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