NCT07083310

Brief Summary

Breast cancer is the most common cancer among women worldwide and can be deadly if not found early. Screening tests like mammograms help find breast cancer early, which improves the chances of successful treatment. However, many women do not take part in regular screenings because of fear, lack of knowledge, or other barriers. This study looks at two ways of teaching women about breast cancer and mammogram screening: traditional health education and a counseling approach called motivational interviewing. Motivational interviewing helps women feel more confident and motivated to get screened by talking about their concerns and encouraging positive decisions. The goal is to see which method better increases women's knowledge about breast cancer, their beliefs about health, their confidence in getting mammograms, and their actual participation in screening programs. The results will help improve how we support women in taking care of their breast health.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
78

participants targeted

Target at P25-P50 for not_applicable breast-cancer

Timeline
Completed

Started Jul 2025

Shorter than P25 for not_applicable breast-cancer

Status
not yet 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

First Submitted

Initial submission to the registry

July 1, 2025

Completed
Same day until next milestone

Study Start

First participant enrolled

July 1, 2025

Completed
23 days until next milestone

First Posted

Study publicly available on registry

July 24, 2025

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2025

Completed
Last Updated

July 24, 2025

Status Verified

July 1, 2025

Enrollment Period

3 months

First QC Date

July 1, 2025

Last Update Submit

July 16, 2025

Conditions

Keywords

breast cancermammographymotivational interview

Outcome Measures

Primary Outcomes (1)

  • Mammography Screening Participation Rate

    The rate of participants who attend mammography screening within 6 months will be evaluated using health records and surveys.

    Within 6 months after education/motivational interviewing intervention

Secondary Outcomes (1)

  • Breast Cancer Knowledge Level

    Baseline and 1 month after intervention

Study Arms (3)

Health Education Group

EXPERIMENTAL

Participants will receive structured education sessions focused on increasing knowledge about breast cancer, risk factors, and the importance of early screening.

Behavioral: Health Education

Motivational Interviewing Group

EXPERIMENTAL

Participants will engage in one-on-one counseling sessions using motivational interviewing techniques to enhance motivation and reduce barriers to mammography screening.

Behavioral: Motivational Interviewing

Control Group

NO INTERVENTION

Participants will not receive any intervention during the study period.

Interventions

Structured group education focused on breast cancer awareness, risk reduction, and early detection.

Also known as: Assign to Arm: Health Education Group
Health Education Group

Individual counseling sessions using motivational interviewing to enhance screening behavior.

Also known as: Motivational Interviewing group
Motivational Interviewing Group

Eligibility Criteria

Age40 Years - 69 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Willingness to participate in the study
  • Being a woman aged between 40 and 69 years
  • Being literate
  • Registered at the Family Health Center where the study is conducted

You may not qualify if:

  • Having a first-degree relative (mother/sister) with a history of breast cancer
  • Having had a mammogram in the last two years and/or regularly
  • Having been diagnosed with any type of cancer
  • Being pregnant
  • Being in the postpartum period
  • Having a physical communication impairment (e.g., hearing, speech)
  • Having a diagnosis of neuropsychiatric illness

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Motivational Interviewing

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Directive CounselingCounselingMental Health ServicesBehavioral Disciplines and ActivitiesHealth ServicesHealth Care Facilities Workforce and Services

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
"The study is single-blind; only the participants are unaware of their group assignment, while the investigators are informed."
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Participants were randomized into two intervention groups and one control group using block randomization via a digital program (randomiser.org). Six letter combinations of "A," "B," and "C" were created and randomly assigned to 78 participants in blocks of 13. The sequence of combinations was predetermined (see Figure 3.5). Letters "A," "B," and "C" were assigned to the health education, control, and motivational interviewing groups, respectively.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

July 1, 2025

First Posted

July 24, 2025

Study Start

July 1, 2025

Primary Completion

October 1, 2025

Study Completion

October 1, 2025

Last Updated

July 24, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share