NCT05677737

Brief Summary

Method: It was conducted in a randomized controlled experimental type. The population of the study consisted of 2426 women over the age of 20 living in a family health center in Erzurum between October 2021 and September 2022. The sample of the study consisted of 252 women with 0.05 margin of error and 95% confidence level, according to the sample size calculation formula used in cases where the universe is known. Within the framework of the exclusion criteria of the study, 52 women were excluded from the study and 200 women were included in the randomization.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
165

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2022

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 15, 2022

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

December 29, 2022

Completed
12 days until next milestone

First Posted

Study publicly available on registry

January 10, 2023

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 28, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 15, 2023

Completed
Last Updated

July 19, 2023

Status Verified

July 1, 2023

Enrollment Period

10 months

First QC Date

December 29, 2022

Last Update Submit

July 18, 2023

Conditions

Outcome Measures

Primary Outcomes (2)

  • Breast Cancer Screening Beliefs Scale

    Breast Cancer Screening Beliefs Questionnaire: The scale was developed by Kwok et al. (2010) in 2010 to determine women's breast cancer screening beliefs. Turkish adaptation, reliability, and validity of the scale were performed by Türkoğlu and Sis Çelik in 2021. The scale has three sub scales including Attitudes towards General Health Checkups, Knowledge and Perceptions about Breast Cancer, and Perceived Barriers to Mammographic Screening. Cronbach's alpha internal coefficients were found to range between 0.76 and 0.87 in the sub-scales of the original scale. The scores to be obtained from the scale range between 0 and 100. Mean scores of 65 and over in the sub-scales indicate that screening beliefs increase positively, knowledge level increases, and barriers to mammography screening decrease.

    two week

  • Health Belief Model Scale in Breast Cancer Screening

    This policy was first established by Champion in 1984 in the Health Belief Model base building. The scale has 8 dimensions: sensitivity, caring, health motivation, BSE barriers, benefits, self-efficacy, mammography benefits and barriers. Necessary components were tested, with the scale's caring and health motivation being revised in 1993, refinement in 1999, and BSE benefits, barriers, and self-efficacy dimensions revised again in 1997 (Champion, 1993; Champion and Scott, 1997; Champion, 1999; Champion, 1984) . Turkish validity and reliability were performed by Gözüm and Aydın in 2004. The scale includes subsections of "sensitivity", "caring", "health motivation", "BSE benefits", "BSE barriers", "BSE self-efficacy". The scale is a Likert-type scale scored from 1 to 5. A score closer to 5 means that caring, health motivation, BSE benefits, BSE barriers and BSE self-efficacy are perceived to be high.

    Two week

Study Arms (2)

Experimental

EXPERIMENTAL

In the study, the women in the experimental group will be trained every two weeks for 6 weeks.

Other: Education

Control

NO INTERVENTION

No intervention will be applied to the control group.

Interventions

Educational program; It will be applied to the individuals in the experimental group for an average of 40 minutes in a time period they are suitable through the online platform prepared for the individuals in the experimental group in a three-month period. The literature will be scanned and appropriate educational materials will be created, and videos will be used to support education. Educational program During the first interview, the individuals in the experimental group will be introduced to the online platform, their entrance will be provided, they will be informed about how to follow the trainings, and sample applications will be made. Six main topics will be covered in the training program and will be completed every two weeks in three months.

Experimental

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Being over 18 years old
  • Being literate,
  • Computer can be used,
  • Internet is accessible,
  • Not getting breast cancer before,

You may not qualify if:

  • Having received training on breast cancer before
  • Having a history of breast cancer in first degree relatives
  • Those who did not attend all of the online trainings in the experimental group

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ataturk Unıversity

Erzurum, Yakutiye, 25240, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Educational Status

Intervention Hierarchy (Ancestors)

Socioeconomic FactorsPopulation Characteristics

Study Officials

  • Aslı Sis Çelik, Assoc. Prof.

    Ataturk University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assist Prof.

Study Record Dates

First Submitted

December 29, 2022

First Posted

January 10, 2023

Study Start

August 15, 2022

Primary Completion

May 28, 2023

Study Completion

July 15, 2023

Last Updated

July 19, 2023

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will not share

Locations