Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT06022900 |
| Other study ID # |
BREASTCANCER |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
March 9, 2023 |
| Est. completion date |
May 26, 2023 |
Study information
| Verified date |
August 2023 |
| Source |
Saglik Bilimleri Universitesi Gulhane Tip Fakultesi |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Objective: In this study, it was aimed to determine the effects of health education provided
by two different methods on breast cancer and mammography knowledge self-evaluation status,
perceived mammography benefit and barrier levels, mammography self-efficacy levels and
mammography screening of women aged 40-69 years.
Materials and Methods: The study was conducted in a parallel group design as a single-blind
randomized controlled trial. The sample consisted of 126 healthy volunteers, 42 in each
group, who were registered to Toprakkale Family Health Center between January and July 2023,
met the inclusion criteria. In the study, 10-unit Visual Analogue Scale, mammography benefit
and obstacle perception sub-dimension of Champion's Health Belief Model Scale and Mammography
Self-Efficacy Scale were used for self-assessment of breast cancer and mammography knowledge.
In the study, while the control group received standard care, the face-to-face education
group was given health education and brochures through home visits, and a reminder interview
was made over the phone. Health education and digital brochures were given to the online
training group via video call, and a reminder meeting was held once. After a two-month
follow-up, One-Way Analysis of Variance and Kruskal Wallis H test were used to compare the
data of the three groups, multiple comparisons were analyzed with Tukey's test and Dunn's
test. Generalized Linear Models were used for group and time comparisons.
Description:
This study was conducted as a parallel group, single-blind randomized controlled trial. The
study was carried out in Osmaniye Province Toprakkale Family Health Center between January -
July 2023. In this study, it was calculated that at least 96 participants should be included
in three groups with effect size d=0.18, 95% power and 0.05 error level. G Power 3.1.9.2
package program was used in the calculation. Considering the possible data loss in the study,
it was decided to add 30% of the participants. In this context, the sample of the study was
determined as 126 participants, 42 in each group. After briefing the women aged 40-69 who
came to the FHC for any reason about the purpose of the study, the researcher invited them to
participate in the study. Subsequently, it examined the inclusion criteria of women who
volunteered to participate in the study. The purpose of the study was explained to the
participants who met the inclusion criteria and Form I was administered to the participants.
In the randomization of the participants, the block randomization method was preferred.
Following the administration of Form I, the participants were assigned to the group in the
block randomization list according to the order of arrival at the FHC. No intervention was
made to the control group during the application process. Participants in the online training
group received online health training and a digital training brochure. Participants in the
face-to-face training group received face-to-face health education through home visits and a
training brochure. Four weeks later, the participants in the online and face-to-face training
groups were given a telephone reminder call. At the end of eight weeks, Form II was
administered to all groups.
