NCT05723237

Brief Summary

The lack of knowledge of women on breast cancer and health literacy poses a major obstacle to people's breast cancer screening behaviors and beliefs. In order to increase social sensitivity and awareness on this issue; In particular, it is important to research, examine and examine how the municipalities and their employees, who are representatives of the society, evaluate breast cancer screening studies. The aim of our project is to evaluate the effect of breast cancer screening training given to women working in the municipality on health literacy, breast cancer screening belief and behavior. This study will be conducted in a randomized-controlled experimental design with women (n=120) working in a municipality in Istanbul Province between November 2022 and November 2023. Data will be obtained face-to-face using the Participant Information Form, the Health Literacy Scale and the Breast Cancer Screening Beliefs Scale. The women in the experimental group (n=60) will be given 16 hours of breast cancer screening training, two days a week, two hours a day (60 min+60 min) for four weeks, by the researchers. No application will be made to the control group (n=60). Follow-up evaluations of the research will be completed in the following six months. The Health Literacy Scale and Breast Cancer Screening Beliefs Scale will be re-administered to all women in the experimental and control groups at the first follow-up after three months and at the second follow-up after 6 months. The data will be analyzed with statistical methods and the effectiveness of the training will be evaluated. When the project is concluded; The results will be presented as an article in a national or international journal, or as an oral presentation at a national or international congress. It will be ensured that breast cancer screening training given to women working in the municipality will increase their level of health literacy, have a positive effect on breast cancer screening belief and behavior, and increase their awareness and knowledge level on this subject. In the long term, widespread effects such as reducing the costs women spend on breast cancer, reducing mortality and morbidity rates, raising a conscious society, training undergraduate students involved in the project, and helping them learn by experiencing the research conducted at the national level are foreseen.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2023

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

February 3, 2023

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 10, 2023

Completed
5 days until next milestone

Study Start

First participant enrolled

February 15, 2023

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 15, 2023

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2023

Completed
Last Updated

May 24, 2023

Status Verified

May 1, 2023

Enrollment Period

6 months

First QC Date

February 3, 2023

Last Update Submit

May 22, 2023

Conditions

Outcome Measures

Primary Outcomes (7)

  • Information Form

    It includes demographic information such as age, education level, income level, occupation, and duration of employment. In addition, it includes questions about whether they have sufficient information about breast cancer screening, whether they have received education, smoking status, and whether they have a chronic disease.

    1. day

  • Health Literacy Scale

    It is a five-point Likert scale containing 25 items. There is a positive relationship between the total score obtained from the scale and health literacy, and as the score obtained from the scale increases, the health literacy level of individuals also increases. It consists of four sub-dimensions. The first sub-dimension, Access to Information, consists of five items (1-5). The Comprehension of Information sub-dimension consists of seven items (items 6-12). The Evaluation/Evaluation sub-dimension consists of eight items (items 13 to 20). The Application/Using sub-dimension includes five items (items 21-25). The minimum score that can be obtained from the scale is 25; The maximum is 125 points.

    1. day

  • Health Literacy Scale

    It is a five-point Likert scale containing 25 items. There is a positive relationship between the total score obtained from the scale and health literacy, and as the score obtained from the scale increases, the health literacy level of individuals also increases. It consists of four sub-dimensions. The first sub-dimension, Access to Information, consists of five items (1-5). The Comprehension of Information sub-dimension consists of seven items (items 6-12). The Evaluation/Evaluation sub-dimension consists of eight items (items 13 to 20). The Application/Using sub-dimension includes five items (items 21-25). The minimum score that can be obtained from the scale is 25; The maximum is 125 points.

    30th day

  • Health Literacy Scale

    It is a five-point Likert scale containing 25 items. There is a positive relationship between the total score obtained from the scale and health literacy, and as the score obtained from the scale increases, the health literacy level of individuals also increases. It consists of four sub-dimensions. The first sub-dimension, Access to Information, consists of five items (1-5). The Comprehension of Information sub-dimension consists of seven items (items 6-12). The Evaluation/Evaluation sub-dimension consists of eight items (items 13 to 20). The Application/Using sub-dimension includes five items (items 21-25). The minimum score that can be obtained from the scale is 25; The maximum is 125 points.

    60th day

  • Breast Cancer Screening Beliefs Scale

    The scale consists of 13 items. The scale consists of three sub-dimensions. Attitude towards health screenings sub-dimension items 1, 2, 3 and 4, breast cancer knowledge and perceptions sub-dimension items 5, 6, 7 and 8, and obstacles for mammography screenings sub-dimension 9, 10, 11, 12 and 13 consists of substances.The lowest score obtained from the scale is 0, and the highest score is 100. The fact that the mean score of the sub-dimensions of the scale is 65 and above indicates that screening beliefs have increased positively, their level of knowledge has increased and the barriers to mammography screening have decreased.

    1. day

  • Breast Cancer Screening Beliefs Scale

    The scale consists of 13 items. The scale consists of three sub-dimensions. Attitude towards health screenings sub-dimension items 1, 2, 3 and 4, breast cancer knowledge and perceptions sub-dimension items 5, 6, 7 and 8, and obstacles for mammography screenings sub-dimension 9, 10, 11, 12 and 13 consists of substances.The lowest score obtained from the scale is 0, and the highest score is 100. The fact that the mean score of the sub-dimensions of the scale is 65 and above indicates that screening beliefs have increased positively, their level of knowledge has increased and the barriers to mammography screening have decreased.

    30th day

  • Breast Cancer Screening Beliefs Scale

    The scale consists of 13 items. The scale consists of three sub-dimensions. Attitude towards health screenings sub-dimension items 1, 2, 3 and 4, breast cancer knowledge and perceptions sub-dimension items 5, 6, 7 and 8, and obstacles for mammography screenings sub-dimension 9, 10, 11, 12 and 13 consists of substances.The lowest score obtained from the scale is 0, and the highest score is 100. The fact that the mean score of the sub-dimensions of the scale is 65 and above indicates that screening beliefs have increased positively, their level of knowledge has increased and the barriers to mammography screening have decreased.

    60th day

Study Arms (2)

Experiment

EXPERIMENTAL

The women in the experimental group (n=60) will be given 16 hours of breast cancer screening training, two days a week, two hours a day (60 min+60 min) for four weeks, by the researchers.

Other: Breast Cancer Education

Control Group

NO INTERVENTION

No application will be made to the control group (n=60).

Interventions

The women in the experimental group (n=60) will be given 16 hours of breast cancer screening training, two days a week, two hours a day (60 min+60 min) for four weeks, by the researchers.

Experiment

Eligibility Criteria

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

You may qualify if:

  • Women aged 18 and over,
  • Volunteering to participate in the study,
  • Working in the municipality for at least 1 month and
  • Not having any communication problems

You may not qualify if:

  • Women who have any communication barrier and
  • Do not volunteer to participate in the study will be excluded from the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul Aydin University

Istanbul, Turkey (Türkiye)

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 3, 2023

First Posted

February 10, 2023

Study Start

February 15, 2023

Primary Completion

August 15, 2023

Study Completion

December 30, 2023

Last Updated

May 24, 2023

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will not share

Locations