NCT06022900

Brief Summary

Objective: This study aimed to explore how face-to-face and online health education influenced several factors related to breast cancer, including individuals' self-reported knowledge of breast cancer and mammography, perceptions of the benefits and barriers to mammography, self-confidence in undergoing mammography, and the rates of participation in screening programs. Materials and Methods: This research utilized a parallel group design within a single-blind randomized controlled trial framework. A total of 126 healthy participants were recruited, equally divided into three groups of 42, from individuals enrolled at the Toprakkale Family Health Center between January and July 2023, all of whom met the eligibility requirements.In this study, a 10-point Visual Analogue Scale, along with the mammography benefit and barrier perception sub-dimensions from Champion's Health Belief Model Scale and the Mammography Self-Efficacy Scale, were utilized for participants to self-assess their knowledge regarding breast cancer and mammography. While the control group received standard care, the face-to-face education group benefited from health education and informational brochures delivered through home visits, supplemented by a follow-up reminder call. Meanwhile, the online training group received health education and digital brochures via video calls, along with one reminder session. Following a two-month follow-up period, data from the three groups were compared using One-Way Analysis of Variance and the Kruskal-Wallis H test. Multiple comparisons were conducted using Tukey's test and Dunn's test, while Generalized Linear Models were employed for assessing group and time differences.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
126

participants targeted

Target at P50-P75 for not_applicable breast-cancer

Timeline
Completed

Started Mar 2023

Shorter than P25 for not_applicable breast-cancer

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 9, 2023

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 17, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 26, 2023

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

August 21, 2023

Completed
15 days until next milestone

First Posted

Study publicly available on registry

September 5, 2023

Completed
Last Updated

October 9, 2024

Status Verified

August 1, 2023

Enrollment Period

1 month

First QC Date

August 21, 2023

Last Update Submit

October 7, 2024

Conditions

Keywords

Breast CancerMammographyHealth EducationOnline EducationHome Visit

Outcome Measures

Primary Outcomes (1)

  • Self-Efficacy Scale for Mammography

    The scale comprises 10 items, each rated on a 5-point Likert type format. The total score that can be achieved ranges from 10 to 50.

    60 days

Secondary Outcomes (1)

  • Champion's Health Belief Model Scale

    60 days

Study Arms (3)

Control group

NO INTERVENTION

During the study period, this group participated in the standard breast cancer screening program, which is a nationwide health initiative implemented throughout the country to promote early detection and prevention of breast cancer.

Online training group

EXPERIMENTAL

Alongside the standard breast cancer screening services, participants in this group were offered comprehensive online health education that emphasized both breast cancer awareness and prevention strategies. Additionally, they received a digital educational brochure designed to enhance their understanding of the disease. Four weeks after their enrollment in the study, participants were contacted via phone to reinforce the significance of regular screenings and to provide them with a summary of essential information regarding the benefits of early detection.

Behavioral: Online training group

Face-to-face training group

EXPERIMENTAL

In addition to the standard breast cancer screening services, individuals in this group received tailored in-person health education regarding breast cancer and its prevention through comprehensive home visits, which included a well-designed training brochure. At the conclusion of the fourth week following their enrollment in the study, participants were contacted via phone to emphasize the critical importance of regular screening. During this call, they were provided with a concise summary of key information aimed at reinforcing the benefits of early detection and encouraging ongoing participation in screening programs.

Behavioral: Face-to-face training group

Interventions

online health education with video call

Online training group

Face-to-face health education with home visit

Face-to-face training group

Eligibility Criteria

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

You may qualify if:

  • Must voluntarily agree to participate in the research. Must be literate in Turkish. Must be aged between 40 and 69 years. Must identify as a woman. Must have access to the necessary technology for video calls.

You may not qualify if:

  • Any barriers to effective communication. Currently pregnant or in the postpartum period. Currently breastfeeding. Having undergone a mammogram within the past two years. A history of benign breast disease or breast cancer. A family history of breast cancer.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Health Sciences

Ankara, Ankara, 06000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Breast NeoplasmsHealth Education

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesAdherence InterventionsMedication AdherencePatient CompliancePatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Study Officials

  • Serpil Ozdemir, PhD

    Sağlık Bilimleri Üniversitesi Gülhane Hemşirelik Fakültesi

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Single (Participant); single blind study, participants do not know their group
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: Parallel Assignment randomised control trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD RN

Study Record Dates

First Submitted

August 21, 2023

First Posted

September 5, 2023

Study Start

March 9, 2023

Primary Completion

April 17, 2023

Study Completion

May 26, 2023

Last Updated

October 9, 2024

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will not share

Locations