The Effect of Health Education on Breast Cancer

NCT ID: NCT06022900

Last Updated: 2024-10-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 126 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-09
• Study Completion Date: 2023-05-26

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.

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.

Conditions

Breast Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

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.

Group Type: EXPERIMENTAL

Online training group

Intervention Type: BEHAVIORAL

online health education with video call

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.

Group Type: EXPERIMENTAL

Face-to-face training group

Intervention Type: BEHAVIORAL

Face-to-face health education with home visit

Interventions

Online training group

online health education with video call

Intervention Type: BEHAVIORAL

Face-to-face training group

Face-to-face health education with home visit

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 69 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Saglik Bilimleri Universitesi Gulhane Tip Fakultesi

OTHER

Sponsor Role: lead

Responsible Party

Serpil Özdemir

PhD RN

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Serpil Ozdemir, PhD

Role: PRINCIPAL_INVESTIGATOR

Sağlık Bilimleri Üniversitesi Gülhane Hemşirelik Fakültesi

Locations

University of Health Sciences

Ankara, Ankara, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

BREASTCANCER

Identifier Type: -

Identifier Source: org_study_id