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CTRI Number  CTRI/2024/12/078168 [Registered on: 16/12/2024] Trial Registered Prospectively
Last Modified On: 14/12/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Understanding How Men Feel About Breast Cancer Check-ups for Their Partners 
Scientific Title of Study   Exploring Mens Intentions on Their Partners Participation in Breast Cancer Screening 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Rashpreet Kaur Kalsi 
Designation  Student  
Affiliation  Prasanna School of Public Health 
Address  Department of Healthcare and Hospital Management, Prasanna School of Public Health, MAHE, Manipal, Karnataka

Udupi
KARNATAKA
576104
India 
Phone  9359468022  
Fax    
Email  rashpreet.psphmpl2023@learner.manipal.edu  
 
Details of Contact Person
Scientific Query
 
Name  DrSwathi K S 
Designation  Associate Professor  
Affiliation  Prasanna School of Public Health 
Address  Department of Healthcare and Hospital Management, Prasanna School of Public Health, MAHE, Manipal, Karnataka
Department of Healthcare and Hospital Management, Prasanna School of Public Health, MAHE, Manipal, Karnataka
Udupi
KARNATAKA
576104
India 
Phone  9481749911  
Fax    
Email  swathi.ks@manipal.edu  
 
Details of Contact Person
Public Query
 
Name  DrSwathi K S 
Designation  Associate Professor  
Affiliation  Prasanna School of Public Health 
Address  Department of Healthcare and Hospital Management, Prasanna School of Public Health, MAHE, Manipal, Karnataka
Department of Healthcare and Hospital Management, Prasanna School of Public Health, MAHE, Manipal, Karnataka
Udupi
KARNATAKA
576104
India 
Phone  9481749911  
Fax    
Email  swathi.ks@manipal.edu  
 
Source of Monetary or Material Support  
Department of Healthcare and Hospital Management, Prasanna School of Public Health, Madhav Nagar, Manipal, Udupi, Karnataka, India 576104 
 
Primary Sponsor  
Name  Rashpreet Kaur Kalsi 
Address  Department of Healthcare and Hospital Management, Prasanna School of Public Health, MAHE, 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 = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Rashpreet Kaur Kalsi  Prasanna School of Public Health  Department of Healthcare and Hospital Management, Prasanna School of Public Health, MAHE, Manipal, Karnataka
Udupi
KARNATAKA 
9359468022

rashpreet.psphmpl2023@learner.manipal.edu 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee-2 (Student Research)  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Breast Cancer  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  21.00 Year(s)
Age To  60.00 Year(s)
Gender  Male 
Details  1. Men aged 21 years and above.
2. Men willing to participate.
3. Men who can read and understand the English language.
4. Men willing to provide informed consent to participate in the study.
 
 
ExclusionCriteria 
Details  1. Men who are not willing to provide consent.
2. Men with cognitive or neurological disorders.
3. Men below the age of 21 years.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
This study will evaluate factors influencing mens intentions to support their partners participation in breast cancer screening  8 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
It will examine their attitudes, subjective norms, and perceived structural barriers and habits, and how health literacy influences their attitudes and subjective norms.   8 weeks 
 
Target Sample Size   Total Sample Size="422"
Sample Size from India="422" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="430" 
Phase of Trial   N/A 
Date of First Enrollment (India)   25/12/2024 
Date of Study Completion (India) 10/01/2025 
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  
Aim: The main aim of the study is to investigate the factors that influence men’s intention to support their partner’s participation in breast cancer screening using the modified Theory of Planned Behavior (TPB).
Objectives:
1. To understand the factors influencing men’s intention to support their partner’s participation in breast cancer screening.
2. To assess the association of health literacy and knowledge on the attitude and subjective norms towards breast cancer screening intentions.
Justification for study:
Breast cancer is the most common malignancy among women worldwide and the leading cause of cancer incidence and mortality in India, responsible for 13.5% of new cancer cases and 10% of cancer-related deaths in 2020.  Women’s decision to undergo screening often depends on their husbands’ or partners’ opinions, particularly in low-middle-income countries (LMlCs) like India. Men play significant roles in their partner’s health, ranging from joint decision-making or granting permission to providing financial support and transportation. Given the importance of men’s role in the promotion of breast cancer screening, it is crucial to identify the factors that determine their support for screening. This study aims to fill the gap by understanding the determinants of men’s support for breast cancer screening using modified Theory of Planned Behavior. It will address factors such as knowledge about breast cancer and screening, attitude, subjective norms, perceived barriers, and other factors such as personal habits and health literacy, which may influence health-related support behaviors.

Detailed description of procedure/processes:
This study will adopt a cross-sectional study design utilizing a survey method. The study protocol will be submitted for approval from the Institutional Ethics Committee (IEC).
A pre-validated structured questionnaire, consisting of Likert scale items, is developed to measure various aspects related to the study, such as demographics, knowledge and awareness about breast cancer and screening, attitudes, subjective norms, perceived barriers, health habits, health literacy, and intentions to support partners’ participation in breast cancer screening. Participants will be recruited via convenience sampling and contacted through social media platforms and messaging apps such as WhatsApp, SMS, and email. Primary respondents will be encouraged to share the survey with their contacts (secondary respondents). Eligible participants will be men aged 21 years and above who consent to participate. Detailed information about the study, including its objectives, procedures, and potential risks and benefits, will be provided to all participants. Those who agree to participate will receive a link to the survey, hosted as a Google Form. The first page of the survey will include a consent form detailing the study. Only those who provide informed consent will complete the questionnaire. Data collected will be self-reported and analyzed using appropriate statistical methods, with Jamovi software used for analysis.
Benefits: The study will help identify key factors influencing men’s intentions to support their partner’s breast cancer screening and understand the role of health literacy and knowledge in shaping men’s attitudes and beliefs towards breast cancer screening.




 
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