Clinical trial NCT06022900: The Effect of Health Education on Breast Cancer
Official title: The Impact of Two Distinct Health Education Approaches on Mammography Self-Efficacy, Health Beliefs, and Screening Program Participation: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Keywords: Breast Cancer
Mammography
Health Education
Online Education
Home Visit
Lead sponsor: Saglik Bilimleri Universitesi Gulhane Tip Fakultesi
Sponsor class: OTHER
First posted: 2023-09-05
Enrollment: 126
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel Assignment randomised control trial
Primary purpose: OTHER

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.

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.

Primary outcomes:
measure: Self-Efficacy Scale for Mammography
timeFrame: 60 days
Secondary outcomes:
measure: Champion's Health Belief Model Scale
timeFrame: 60 days
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: University of Health Sciences
Study officials:
affiliation: Sağlık Bilimleri Üniversitesi Gülhane Hemşirelik Fakültesi
name: Serpil Ozdemir, PhD
role: PRINCIPAL_INVESTIGATOR
References: