NCT07149636

Brief 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. 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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3,000

participants targeted

Target at P75+ for all trials

Timeline
4mo left

Started Jun 2023

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress90%
Jun 2023Sep 2026

Study Start

First participant enrolled

June 1, 2023

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2025

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

August 18, 2025

Completed
15 days until next milestone

First Posted

Study publicly available on registry

September 2, 2025

Completed
12 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2026

Expected
Last Updated

September 2, 2025

Status Verified

August 1, 2025

Enrollment Period

2 years

First QC Date

August 18, 2025

Last Update Submit

August 28, 2025

Conditions

Keywords

Breast Self-ExaminationBreast Cancer ScreeningHealth Belief ModelWomen's HealthCommunity Health EducationPreventive Health BehaviorEarly Detection of Breast Cancer

Outcome Measures

Primary Outcomes (1)

  • 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.

    Day 1

Secondary Outcomes (3)

  • Percentage of Participants Knowing the Correct Method of BSE

    Day 1

  • Percentage of Participants Aware of the Importance of BSE

    Day 1

  • Distribution of Self-Reported Barriers to Regular Health Examinations

    Day 1

Study Arms (1)

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.

Eligibility Criteria

Age40 Years - 99 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsSelf-identified females (including cisgender and transgender women) aged approximately 40 years and older.
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking union medical college hospital

Beijing, 100730, China

Location

MeSH Terms

Conditions

Breast NeoplasmsBreast Self-ExaminationHealth Education

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesSelf-ExaminationHealth BehaviorBehaviorAdherence InterventionsMedication AdherencePatient CompliancePatient Acceptance of Health CareTreatment Adherence and Compliance

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 18, 2025

First Posted

September 2, 2025

Study Start

June 1, 2023

Primary Completion

June 1, 2025

Study Completion (Estimated)

September 1, 2026

Last Updated

September 2, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL, SAP
Time Frame
Start Date: 6 months after publication of the primary manuscript. End Date: Available for 3 years after publication.
Access Criteria
Qualified researchers affiliated with academic or non-profit institutions may request access to the de-identified individual participant data (IPD) and supporting documents (study protocol, statistical analysis plan, informed consent form, and analytic code) for purposes of conducting scientifically valid analyses. Requests must include a research proposal outlining objectives, methodology, and intended use of the data, and will be reviewed by the study steering committee. Approved requestors will be required to sign a data sharing agreement and comply with applicable data protection regulations. Data will be shared through a secure, password-protected data repository.

Locations