NCT06690320

Brief Summary

Purpose: This project aims to examine the effects of planned education on health beliefs and fatalism in women at high risk of breast cancer. When national and international literature was examined, no project was found in which the health beliefs and fatalism of high-risk women in breast cancer were determined and then the results were evaluated by implementing a planned education. Therefore, planning an original project in this field aims to contribute to the literature. Scope and Target Group: The project will be carried out with women who applied to Ordu Education and Research Hospital Family Medicine and General Surgery Breast Polyclinic within the borders of Ordu province and who received 301 and above points from the breast cancer risk assessment form (N=72). Ordu University Education and Research Hospital is a hospital that provides services with an affiliation protocol within the framework of the "Regulation on the Methods and Principles of Cooperation with the Joint Use of the Institutions and Organizations of the Ministry of Health and its Affiliated Organizations and the Relevant Units of State Universities". Method and Expected Result: The project was planned as a randomized controlled experimental follow-up study with a pre-test-post-test control group design in order to examine the effect of planned education on health beliefs and fatalism in women at high risk of breast cancer. Planned education intervention will be applied to women at high risk of breast cancer whose health beliefs and fatalistic tendencies have been determined. Planned education will provide breast self-examination (BSE) on the model closest to human tissue, and pathologies related to breast cancer will be detected on the model by touching the model. An approach based on raising awareness of breast cancer and learning early diagnosis methods through doing and living experience will be provided. Therefore, it is expected that the planned education applied by doing and experiencing on a model close to human tissue will be effective in gaining and implementing health behaviors in women with known health beliefs and fatalistic tendencies at high risk of breast cancer. In addition, it is expected that the application by doing and experiencing will be effective in gaining permanent health behaviors.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
72

participants targeted

Target at P25-P50 for not_applicable breast-cancer

Timeline
Completed

Started Jan 2023

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 17, 2023

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

October 20, 2024

Completed
26 days until next milestone

First Posted

Study publicly available on registry

November 15, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2024

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2025

Completed
Last Updated

November 15, 2024

Status Verified

October 1, 2024

Enrollment Period

2 years

First QC Date

October 20, 2024

Last Update Submit

November 14, 2024

Conditions

Keywords

breast cancerhealth belief modelfatalismpublic health nursingnurseearly diagnosis of cancer

Outcome Measures

Primary Outcomes (1)

  • Champion's Health Belief Model Scale

    The health belief model scale will be applied to the experimental and control groups. Pre-test-post-test data to evaluate the effectiveness of the intervention for nurses who will attempt to change/improve women's beliefs and behaviors regarding breast cancer and screening behaviors. In the Turkish adaptation of the scale. CSİMO has 6 sub-dimensions and the items are listed in the order of the data below. Each sub-dimension of the scale is evaluated separately, the total score including the entire scale is not calculated. Women who score low on the "perception of obstacle" sub-scale and high on other sub-scales show that they have positive attitudes and beliefs

    15 days

Secondary Outcomes (1)

  • Powe's Breast Cancer Fatalism Scale

    15 days

Other Outcomes (1)

  • BREAST CANCER RISK ASSESSMENT FORM

    Baseline

Study Arms (2)

control group

NO INTERVENTION

No application will be made to the control group. After the research is completed, a planned training program can be applied to the experimental group upon request by the researcher within the framework of ethical responsibilities.

experiment group

EXPERIMENTAL

A one-session planned training program will be applied to the experimental group.

Behavioral: IMPLEMENTATION OF A PLANNED EDUCATION PROGRAM ON HEALTH BELIEF MODEL AND FATUALIST TENDENCIES IN WOMEN AT HIGH RISK OF BREAST CANCER

Interventions

Description: By examining the parameters of the health belief model and fatalism scales, 6 targets were determined for these scale parameters. The targets were prepared to gain early diagnosis behaviors in breast cancer. By using the breast model, the behavior will be demonstrated in practice

experiment group

Eligibility Criteria

Age30 Years+
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Being 30 years of age or older, Being at least literate, Getting a score of 301 or higher from the Breast Cancer Risk Assessment Form, Not having vision or hearing loss that would prevent communication, Accepting participation in the study voluntarily.

You may not qualify if:

  • Being a healthcare professional,
  • Having received genetic counseling for breast cancer due to a breast cancer diagnosis in a 1st, 2nd or 3rd degree relative,
  • Having received breast cancer early diagnosis training within the last 1 year,
  • Those who were diagnosed with breast cancer and received treatment during the study period will not be included in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ege UnIversty

Bornova, İzmir, 35030, Turkey (Türkiye)

Location

Related Publications (3)

  • Andic S, Karayurt O. Determination of information and support needs of first degree relatives of women with breast cancer. Asian Pac J Cancer Prev. 2012;13(9):4491-9. doi: 10.7314/apjcp.2012.13.9.4491.

  • Kharameh ZT, Foroozanfar S, Zamanian H. Psychometric properties of the Persian version of Champion's Health Belief Model Scale for colorectal cancer screening. Asian Pac J Cancer Prev. 2014;15(11):4595-9. doi: 10.7314/apjcp.2014.15.11.4595.

  • Sung H, Ferlay J, Siegel RL, Laversanne M, Soerjomataram I, Jemal A, Bray F. Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries. CA Cancer J Clin. 2021 May;71(3):209-249. doi: 10.3322/caac.21660. Epub 2021 Feb 4.

Related Links

MeSH Terms

Conditions

Breast NeoplasmsHealth BehaviorBreast Self-Examination

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesBehaviorSelf-Examination

Study Officials

  • gülşen çalış

    gulsencalis81@gmail.com

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
statistical evaluation of the research results will be made by an expert other than the researcher
Purpose
SCREENING
Intervention Model
PARALLEL
Model Details: Research population: The population of this research consists of women who received 301 or more points from the breast cancer risk assessment form who applied to the family medicine polyclinic and general surgery breast polyclinic of Ordu University Training and Research Hospital in Ordu province between 2023-2024. In the study, the sample size was calculated at a 95% confidence level using the "G. Power-3.1.9.2" program. As a result of the analysis, the standardized effect size was found to be 1.1270 at the α=0.05 level, based on the previous study, and the minimum sample size was calculated as 60 with a theoretical power of 0.99, 30 for the experimental group and 30 for the control group. Considering the losses, it was decided to collect 20% more and it was aimed to reach 72 people, 36 for the experimental group and 36 for the control group.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
NURSE

Study Record Dates

First Submitted

October 20, 2024

First Posted

November 15, 2024

Study Start

January 17, 2023

Primary Completion

December 30, 2024

Study Completion

September 30, 2025

Last Updated

November 15, 2024

Record last verified: 2024-10

Data Sharing

IPD Sharing
Will not share

Locations