Breast NeoplasmsHBM-BSENCT07149636
Health Belief Model-Based Survey on Breast Self-Examination Awareness and Practice Among Community-Dwelling Middle-Aged and Older Women
An observational study of Breast Neoplasms and Breast Self-Examination, run by Peking Union Medical College Hospital at 1 site in China.
Trial summary
This observational study aims to evaluate the current status of breast self-examination (BSE) practices and related influencing factors among middle-aged and older women in urban communities, using the Health Belief Model (HBM) as the theoretical framework. Read more about this study
- Who is it for?
- Ages 40 to 99 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Neoplasms, Breast Self-Examination, Cancer Screening
- How many people
- 3,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2023to 1 Sep 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 99 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: This study will recruit community-dwelling women aged approximately 40 years and above from multiple urban and suburban residential areas in Beijing, China. Participants will be permanent residents who have lived in the community for at least 6 months and are able to communicate effectively to complete the survey. The study population represents a diverse range of educational backgrounds, occupations, and health awareness levels. All participants will be enrolled during community-based health education and screening activities, and informed consent will be obtained prior to participation.
Who may be able to join
- Self-identified females aged approximately 40 years and older.
- Permanent residents of the selected community for at least 6 months.
- Able to communicate and understand the survey questions clearly.
- Provide informed consent to participate in the study.
Who cannot join
- History of breast cancer or other serious breast diseases requiring ongoing treatment.
- Cognitive impairment, severe mental illness, or other conditions affecting the ability to answer the questionnaire.
- Temporary residents or those planning to leave the community within 6 months.
- Refusal to fill out survey.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Health Belief Model-Based Cross-Sectional Study on Breast Self-Examination Awareness, Practices, and Influencing Factors Among Community-Dwelling Middle-Aged and Older Women in China
This observational study aims to evaluate the current status of breast self-examination (BSE) practices and related influencing factors among middle-aged and older women in urban communities, using the Health Belief Model (HBM) as the theoretical framework. The HBM is a well-established public health model for understanding preventive health behaviors, focusing on perceived susceptibility, perceived severity, perceived benefits, perceived barriers, cues to action, and self-efficacy.
The study will recruit community-dwelling women above approximately 40 years of age who have adequate cognitive and communication abilities. Data collection will be conducted through structured questionnaires administered during community health education activities. The survey will collect demographic information (e.g., age, occupation, education level, family history of breast cancer) and BSE-related variables, including awareness of breast cancer, perceived benefits and barriers to screening, knowledge of BSE methods, and sources of health information.
Read more
The primary outcome is the prevalence of regular BSE practices among participants. Secondary outcomes include factors associated with regular BSE performance, such as age group, occupation type, education level, family history, and knowledge of BSE techniques. Logistic regression will be used to identify independent predictors of regular BSE practices.
Findings from this study will help identify key gaps between awareness and practice, guide targeted community-based health education, and provide evidence for developing accessible, culturally appropriate breast cancer screening strategies in China. Ultimately, the results are expected to improve early detection rates and reduce the proportion of locally advanced breast cancer cases.
Read the detailed description
This observational cross-sectional study is designed to investigate the prevalence and determinants of breast self-examination (BSE) practices among community-dwelling women in China, based on the Health Belief Model (HBM). Breast cancer remains the most common malignancy among women worldwide. While imaging-based screening programs have improved early detection rates in many high-income countries, large segments of the population in low- and middle-income settings still face barriers to regular breast cancer screening. In China, BSE remains a practical and low-cost complementary method for early detection, particularly in areas where mammography coverage is incomplete.
The Health Belief Model (HBM) is a theoretical framework widely used to explain preventive health behaviors and adherence to disease management. It encompasses six core dimensions: (1) perceived susceptibility to the disease, (2) perceived severity of the disease, (3) perceived benefits of preventive actions, (4) perceived barriers to taking action, (5) cues to action, and (6) self-efficacy in carrying out the preventive behavior. The present study applies the HBM framework to systematically assess the psychosocial and cognitive factors influencing BSE behaviors in Chinese women.
Study Population and Setting Participants will be recruited from multiple community health centers in Beijing. Eligible participants are women aged approximately 40 years and above, who are permanent residents in the community, possess adequate cognitive and communication abilities, and provide informed consent. Exclusion criteria include history of breast cancer, severe psychiatric illness, or inability to complete the survey.
Data Collection Procedures
Data will be collected during community health promotion activities between June 2023 and June 2025. A standardized, structured questionnaire will be used, consisting of two major sections:
- Demographic and background information: age, occupation, education level, family history of breast cancer, and health examination history.
- HBM-based measurement items:
- Awareness of breast cancer as a common malignancy
- Awareness of the importance of breast cancer screening and BSE
- Frequency of undergoing health examinations
- Main barriers to regular health examinations (e.g., financial concerns, lack of companion, perceived lack of necessity, other)
- Knowledge of BSE methods and sources of information (traditional media, modern media, in-person health education)
- Confidence in performing BSE correctly and regularly
For categorical questions, binary or multiple-choice options will be used. Open-ended questions will be coded into predefined categories based on pilot survey responses.
Quality Control Measures Prior to the study, a detailed implementation protocol and investigator manual will be developed. A pilot survey will be conducted to refine question wording and improve comprehension. During the survey, trained interviewers will strictly follow standardized procedures, avoid leading questions, and provide neutral clarifications for respondents with low literacy levels. At the end of each survey day, data will be reviewed for completeness and consistency, and invalid questionnaires will be excluded. Data entry will follow a double-entry protocol with logical checks to ensure accuracy.
Data Analysis Plan Descriptive statistics will be used to summarize demographic variables and BSE-related indicators. Categorical variables will be expressed as frequencies and percentages, and compared using Chi-square tests. Continuous variables will be expressed as mean ± standard deviation (SD) and compared using t-tests. Univariate analysis will be followed by multivariate logistic regression to identify independent predictors of regular BSE practices, with results reported as odds ratios (OR) and 95% confidence intervals (CI). A p-value < 0.05 will be considered statistically significant.
Expected Outcomes and Significance This study will quantify the gap between awareness of BSE and actual practice, identify key psychosocial and logistical barriers to regular BSE, and explore how different HBM dimensions contribute to screening behavior. The results will inform the design of tailored community-based health education programs, emphasizing skill-based training rather than solely awareness campaigns. By providing empirical evidence on screening-related behaviors in an urban Chinese population, this research will support policymakers, clinicians, and public health educators in developing culturally adapted, cost-effective strategies for breast cancer early detection.
- Keywords
- Breast Self-Examination, Breast Cancer Screening, Health Belief Model, Women's Health, Community Health Education, Preventive Health Behavior, Early Detection of Breast Cancer
- Medical subject headings
- Breast Neoplasms, Breast Self-Examination, Health Education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Community-Dwelling Women | Women above a certain age threshold residing in urban and suburban communities in Beijing, who meet inclusion criteria and participate in a cross-sectional survey based on the Health Belief Model regarding breast self-examination awareness and practice. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants Performing Regular Breast Self-Examination (BSE)
Percentage of surveyed women who report performing BSE at least once per month, assessed through a standardized questionnaire at the time of study participation.
Measured: Day 1
Secondary outcomes (3)
Percentage of Participants Knowing the Correct Method of BSE
Percentage of surveyed women who report knowing how to correctly perform BSE, assessed through a structured questionnaire.
Measured: Day 1
Percentage of Participants Aware of the Importance of BSE
Percentage of surveyed women who acknowledge the importance and health benefits of BSE, based on responses to a structured questionnaire.
Measured: Day 1
Distribution of Self-Reported Barriers to Regular Health Examinations
Distribution of self-reported barriers to participating in regular health examinations (e.g., financial burden, lack of convenience, perceived irrelevance), assessed through a structured questionnaire.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2025
- Study start1 Jun 2023
- Primary completion1 Jun 2025
- Study completion1 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast NeoplasmsStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 3,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07149636
- Sponsor's protocol ID
- HBM-BSE-PUMCH-2023
- Other IDs
- K8519
- Acronym
- HBM-BSE
- Status last verified
- Aug 2025
- First submitted
- 18 Aug 2025
- Last updated
- 2 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data (IPD) underlying the study results will be made available to qualified researchers upon reasonable request, after publication of the primary results, for a period of 3 years. Requests will be reviewed by the study principal investigator and require a data access agreement.
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Health Belief Model-Based Cross-Sectional Study on Breast Self-Examination Awareness, Practices, and Influencing Factors Among Community-Dwelling Middle-Aged and Older Women in China
- ClinicalTrials.gov ID
- NCT07149636
- Acronym / sponsor ID
- HBM-BSE / HBM-BSE-PUMCH-2023
- Keywords
- Breast Self-Examination, Breast Cancer Screening, Health Belief Model, Women's Health, Community Health Education, Preventive Health Behavior, Early Detection of Breast Cancer
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 1 Jun 2025 (actual)
- Study completion
- 1 Sep 2026 (estimated)
- First posted
- 2 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This observational study aims to evaluate the current status of breast self-examination (BSE) practices and related influencing factors among middle-aged and older women in urban communities, using the Health Belief Model (HBM) as the theoretical framework. The HBM is a well-established public health model for understanding preventive health behaviors, focusing on perceived susceptibility, perceived severity, perceived benefits, perceived barriers, cues to action, and self-efficacy.
The study will recruit community-dwelling women above approximately 40 years of age who have adequate cognitive and communication abilities. Data collection will be conducted through structured questionnaires administered during community health education activities. The survey will collect demographic information (e.g., age, occupation, education level, family history of breast cancer) and BSE-related variables, including awareness of breast cancer, perceived benefits and barriers to screening, knowledge of BSE methods, and sources of health information.
The primary outcome is the prevalence of regular BSE practices among participants. Secondary outcomes include factors associated with regular BSE performance, such as age group, occupation type, education level, family history, and knowledge of BSE techniques. Logistic regression will be used to identify independent predictors of regular BSE practices.
Findings from this study will help identify key gaps between awareness and practice, guide targeted community-based health education, and provide evidence for developing accessible, culturally appropriate breast cancer screening strategies in China. Ultimately, the results are expected to improve early detection rates and reduce the proportion of locally advanced breast cancer cases.
Detailed description
This observational cross-sectional study is designed to investigate the prevalence and determinants of breast self-examination (BSE) practices among community-dwelling women in China, based on the Health Belief Model (HBM). Breast cancer remains the most common malignancy among women worldwide. While imaging-based screening programs have improved early detection rates in many high-income countries, large segments of the population in low- and middle-income settings still face barriers to regular breast cancer screening. In China, BSE remains a practical and low-cost complementary method for early detection, particularly in areas where mammography coverage is incomplete.
The Health Belief Model (HBM) is a theoretical framework widely used to explain preventive health behaviors and adherence to disease management. It encompasses six core dimensions: (1) perceived susceptibility to the disease, (2) perceived severity of the disease, (3) perceived benefits of preventive actions, (4) perceived barriers to taking action, (5) cues to action, and (6) self-efficacy in carrying out the preventive behavior. The present study applies the HBM framework to systematically assess the psychosocial and cognitive factors influencing BSE behaviors in Chinese women.
Study Population and Setting Participants will be recruited from multiple community health centers in Beijing. Eligible participants are women aged approximately 40 years and above, who are permanent residents in the community, possess adequate cognitive and communication abilities, and provide informed consent. Exclusion criteria include history of breast cancer, severe psychiatric illness, or inability to complete the survey.
Data Collection Procedures
Data will be collected during community health promotion activities between June 2023 and June 2025. A standardized, structured questionnaire will be used, consisting of two major sections:
- Demographic and background information: age, occupation, education level, family history of breast cancer, and health examination history.
- HBM-based measurement items:
- Awareness of breast cancer as a common malignancy
- Awareness of the importance of breast cancer screening and BSE
- Frequency of undergoing health examinations
- Main barriers to regular health examinations (e.g., financial concerns, lack of companion, perceived lack of necessity, other)
- Knowledge of BSE methods and sources of information (traditional media, modern media, in-person health education)
- Confidence in performing BSE correctly and regularly
For categorical questions, binary or multiple-choice options will be used. Open-ended questions will be coded into predefined categories based on pilot survey responses.
Quality Control Measures Prior to the study, a detailed implementation protocol and investigator manual will be developed. A pilot survey will be conducted to refine question wording and improve comprehension. During the survey, trained interviewers will strictly follow standardized procedures, avoid leading questions, and provide neutral clarifications for respondents with low literacy levels. At the end of each survey day, data will be reviewed for completeness and consistency, and invalid questionnaires will be excluded. Data entry will follow a double-entry protocol with logical checks to ensure accuracy.
Data Analysis Plan Descriptive statistics will be used to summarize demographic variables and BSE-related indicators. Categorical variables will be expressed as frequencies and percentages, and compared using Chi-square tests. Continuous variables will be expressed as mean ± standard deviation (SD) and compared using t-tests. Univariate analysis will be followed by multivariate logistic regression to identify independent predictors of regular BSE practices, with results reported as odds ratios (OR) and 95% confidence intervals (CI). A p-value < 0.05 will be considered statistically significant.
Expected Outcomes and Significance This study will quantify the gap between awareness of BSE and actual practice, identify key psychosocial and logistical barriers to regular BSE, and explore how different HBM dimensions contribute to screening behavior. The results will inform the design of tailored community-based health education programs, emphasizing skill-based training rather than solely awareness campaigns. By providing empirical evidence on screening-related behaviors in an urban Chinese population, this research will support policymakers, clinicians, and public health educators in developing culturally adapted, cost-effective strategies for breast cancer early detection.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Community-Dwelling Women | – | –Women above a certain age threshold residing in urban and suburban communities in Beijing, who meet inclusion criteria and participate in a cross-sectional survey based on the Health Belief Model regarding breast self-examination awareness and practice. |
Who may qualify
- Ages
- 40 to 99 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- This study will recruit community-dwelling women aged approximately 40 years and above from multiple urban and suburban residential areas in Beijing, China. Participants will be permanent residents who have lived in the community for at least 6 months and are able to communicate effectively to complete the survey. The study population represents a diverse range of educational backgrounds, occupations, and health awareness levels. All participants will be enrolled during community-based health education and screening activities, and informed consent will be obtained prior to participation.
Key inclusion criteria (4 listed)
- Self-identified females aged approximately 40 years and older.
- Permanent residents of the selected community for at least 6 months.
- Able to communicate and understand the survey questions clearly.
- Provide informed consent to participate in the study.
Key exclusion criteria (4 listed)
- History of breast cancer or other serious breast diseases requiring ongoing treatment.
- Cognitive impairment, severe mental illness, or other conditions affecting the ability to answer the questionnaire.
- Temporary residents or those planning to leave the community within 6 months.
- Refusal to fill out survey.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Percentage of Participants Performing Regular Breast Self-Examination (BSE)
Time frame: Day 1
Percentage of surveyed women who report performing BSE at least once per month, assessed through a standardized questionnaire at the time of study participation.
3 secondary outcomes
Percentage of Participants Knowing the Correct Method of BSE
Time frame: Day 1
Percentage of Participants Aware of the Importance of BSE
Time frame: Day 1
Distribution of Self-Reported Barriers to Regular Health Examinations
Time frame: Day 1
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2025.
- Individual participant dataSharing planned: Yes. De-identified individual participant data (IPD) underlying the study results will be made available to qualified researchers upon reasonable request, after publication of the primary results, for a period of 3 years. Requests will be reviewed by the study principal investigator and require a data access agreement.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Neoplasms and Breast Self-Examination, run by Peking Union Medical College Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 2 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants Performing Regular Breast Self-Examination (BSE) (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2025.