The Effect of Health Education on Breast Cancer

The Impact of Two Distinct Health Education Approaches on Mammography Self-Efficacy, Health Beliefs, and Screening Program Participation: a Randomized Controlled Trial

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.

Study Overview

• Status: Completed
• Conditions: Breast Cancer
• Intervention / Treatment: Behavioral: Online training group; Behavioral: Face-to-face training group

Detailed Description

This investigation was structured as a single-blind, parallel-group randomized controlled trial, taking place at the Toprakkale Family Health Center in Osmaniye Province from January to July 2023. A power analysis indicated that at least 96 participants were necessary to achieve a significant effect size (d=0.18) with a 95% power and a 0.05 error margin. The G Power 3.1.9.2 software facilitated these calculations. To mitigate the potential impact of data loss, an additional 30% of participants were included, resulting in a final sample size of 126 individuals, with each of the three groups consisting of 42 participants.

Women aged 40 to 69 who visited the Family Health Center were informed about the study's objectives and subsequently invited to participate. After obtaining consent, the volunteers were screened against the established inclusion criteria. The researchers provided detailed information about the study's goals and handed out Form I to those deemed eligible.

For the purpose of randomization, a block randomization technique was employed, assigning participants to groups based on their order of arrival at the center according to the pre-established randomization list. The control group did not receive any intervention during the study duration. Participants in the online training group were offered digital health education along with an electronic brochure, while those in the face-to-face training group received personalized health education through home visits and a physical training brochure.

Four weeks into the intervention, both the online and face-to-face groups received reminder calls to encourage ongoing engagement. At the conclusion of the eight-week period, all participants completed Form II, allowing for the evaluation of outcomes across all groups.

• Study Type: Interventional
• Enrollment (Actual): 126
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Ankara, Turkey, 06000
    • University of Health Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control group; 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.
Experimental: Online training group; 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; online health education with video call
Experimental: Face-to-face training group; 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; Face-to-face health education with home visit

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Champion's Health Belief Model Scale	Description: This study focused on two specific sub-dimensions of the scale: the perception of benefits associated with mammography and the perception of barriers to mammography. The benefits sub-dimension comprises five items, while the barriers sub-dimension includes eleven items. In this scale, the perceived benefits of mammography are scored on a scale from 5 to 25 points, whereas the perceived barriers to mammography are scored from 11 to 55 points.	60 days

Collaborators and Investigators

• Sponsor: Saglik Bilimleri Universitesi Gulhane Tip Fakultesi
• Investigators: Principal Investigator: Serpil Ozdemir, PhD, Sağlık Bilimleri Üniversitesi Gülhane Hemşirelik Fakültesi

Study record dates

Study Major Dates

• Study Start (Actual): March 9, 2023
• Primary Completion (Actual): April 17, 2023
• Study Completion (Actual): May 26, 2023

Study Registration Dates

• First Submitted: August 21, 2023
• First Submitted That Met QC Criteria: August 28, 2023
• First Posted (Actual): September 5, 2023

Study Record Updates

• Last Update Posted (Estimated): October 9, 2024
• Last Update Submitted That Met QC Criteria: October 7, 2024
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: Breast Cancer; Health Education; Mammography; Home Visit; Online Education
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: BREASTCANCER

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No