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CTRI Number  CTRI/2024/12/078384 [Registered on: 20/12/2024] Trial Registered Prospectively
Last Modified On: 20/12/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Breast Cancer in India: What People Know, Feel and Do About It 
Scientific Title of Study   Breast cancer awareness, attitude and screening among the individuals of India 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Aparna Bijulal Thonoli 
Designation  Student 
Affiliation  Manipal Academy of Higher Education 
Address  Department of Health care and Hospital Management, No division Room No LH 3 Prasanna School of Public Health, Manipal Academy of Higher Education, Udupi, Karnataka, India, 576104

Udupi
KARNATAKA
576104
India 
Phone  8921384150  
Fax    
Email  aparna.psphmpl2023@learner.manipal.edu  
 
Details of Contact Person
Scientific Query
 
Name  Dr Swathi KS 
Designation  Associate Professor 
Affiliation  Manipal Academy of Higher Education 
Address  Department of Health care and Hospital Management, Room No 56, Tiger Circle Road, Madhav Nagar, Manipal, Karnataka, India

Udupi
KARNATAKA
576104
India 
Phone  9481749911  
Fax    
Email  swathi.ks@manipal.edu  
 
Details of Contact Person
Public Query
 
Name  Dr Swathi KS 
Designation  Associate Professor 
Affiliation  Manipal Academy of Higher Education 
Address  Department of Health care and Hospital Management, Room No 56, Tiger Circle Road, Madhav Nagar, Manipal, Karnataka, India

Udupi
KARNATAKA
576104
India 
Phone  9481749911  
Fax    
Email  swathi.ks@manipal.edu  
 
Source of Monetary or Material Support  
Department of Health care and Hospital Management, No division Room No LH 3 Prasanna School of Public Health, Manipal Academy of Higher Education, Udupi, Karnataka, India, 576104 
 
Primary Sponsor  
Name  Aparna Bijulal Thonoli 
Address  Department of Health care and Hospital Management, No division Room No LH 3 Prasanna School of Public Health, Manipal Academy of Higher Education, 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 Swathi KS  Prasanna School of Public Health  Department of Health care and Hospital Management, No division Room No 56 Prasanna School of Public Health, Manipal Academy of Higher Education, Udupi, Karnataka, India, 576104
Udupi
KARNATAKA 
9481749911

swathi.ks@manipal.edu 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Kasturba Medical Collge 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  Awareness and Knowledge on Breast Cancer 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  NIL  NIL 
Intervention  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  • Men and women over the age of 18
• Can read and write in English
• Voluntary participation
 
 
ExclusionCriteria 
Details  • Underage participants
• Individuals already diagnosed with breast cancer
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Awareness levels and knowledge of breast cancer symptoms and its risk factors  8 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
There are no specific secondary outcomes, as this is an observational study focusing on assessing the awareness levels, attitude and screening methods used by people in India.   8 weeks 
 
Target Sample Size   Total Sample Size="424"
Sample Size from India="424" 
Final Enrollment numbers achieved (Total)= "426"
Final Enrollment numbers achieved (India)="426" 
Phase of Trial   N/A 
Date of First Enrollment (India)   31/12/2024 
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  
Aims & objectives:
The aim of this study is to evaluate the level of knowledge about breast cancer risk factors, symptoms and importance of early detection among the individuals of India
- To understand the attitudes and perception towards breast cancer, screening methods and its barriers
- To identify sociocultural factors/ barriers related to breast cancer and screening. 
- To analyse the current screening practices, this would include looking at the types of screening methods and how frequently they are used. 

Justification:
Breast cancer (BC) is one the most prevalent cancers among women, with 2.3 million women diagnosed and 6,70,000 deaths globally in 2022 (WHO., 2024). According to the Globocan data 2020, BC contributed to 10.6% (90,408) of all deaths and 13.5% (1,78,361) of all cancer cases in India (Mehrotra and Yadav., 2022). According to the American Cancer Society, BC detected in the localised stages has a five-year survival rate of 99% (National Breast Cancer Foundation., 2024). 
BC is the most prevalent cancer in India, contributing to 28.2% of all female cancers. Between 1990 and 2016, the incidence of BC among women in India increased by 39.1%, with this rise seen consistently across all Indian states over the 26-year period (Sathishkumar et al., 2024). The 5-year breast cancer survival rate in India is 66.1%, as per the CONCORD-3 study conducted between 2010 and 2014. This is considerably lower than the rates in Australia (89.5%) and the United States of America (90.2%) (Allemani et al., 2018). 
Comprehensive information about the general public’s knowledge, attitudes, and screening practices for breast cancer in this area is lacking. It is essential to understand these factors in order to create focused interventions. It is well known that early detection through routine screening significantly improves survival rates and lowers mortality. Nonetheless, in many regions of India, the use of mammography and other breast cancer screening techniques is still uncommon. Finding the obstacles to screening can help develop plans to increase uptake and, eventually, lower the mortality rate from breast cancer. Lack of awareness, stigma, and ingrained beliefs can make screening procedures less acceptable. By concentrating on these sociocultural factors, the study can shed light on how awareness and attitudes are affected, which will facilitate the creation of culturally appropriate educational initiatives.

Detailed Procedure:
This study will use a cross-sectional design to assess breast cancer awareness, attitudes, and screening practices among the population of India. The research will use quantitative methods to gather data. Prior to the commencement of the study, ethical approval will be sought from Institutional Review Committee and Institutional Ethics Committee. The study will be conducted on individuals which include adults aged 18 or above. Convenience sampling will be used. The questionnaires will be sent through e-mail, WhatsApp and other social media to primary contacts and their secondary contacts through sharing by primary contacts. The study will be excluding individuals with prior diagnosis and individuals with cognitive impairments. The data will be collected through structured questionnaires. The questionnaires will be administered through google forms and will be conducted in English. The questions will cover demographic information, awareness of breast cancer, attitudes, screening and personal screening practices. The collected data will then be analysed using statistical software to identify any significant differences. This study will be conducted from September 2024 to January 2025. Through this procedure, the study aims to provide a comprehensive understanding of breast cancer awareness, attitudes, screening practices among the individuals in India and also look at any barriers that may be faced. 
 
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