| 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
|
|
|
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
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Breast Cancer |
|
|
Intervention / Comparator Agent
|
|
|
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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