| 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
|
|
|
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
|
|
|
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. |