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AzTrials

Breast CancerNCT06690320

Effect of Planned Education on Health Beliefs and Fatalism in Women at High Risk of Breast Cancer

A study testing IMPLEMENTATION OF A PLANNED EDUCATION PROGRAM ON HEALTH BELIEF MODEL AND FATUALIST TENDENCIES IN WOMEN AT HIGH RISK OF BREAST CANCER in people with Breast Cancer and Health Behavior, run by Ege University at 1 site in Turkey (Türkiye).

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Ages 30 years and older, women only
What is being tested?
IMPLEMENTATION OF A PLANNED EDUCATION PROGRAM ON HEALTH BELIEF MODEL AND FATUALIST TENDENCIES IN WOMEN AT HIGH RISK OF BREAST CANCER
Could I receive a placebo?
No, everyone receives an active treatment
How many people
72 participants
Where
1 siteTurkey (Türkiye)
Study dates
17 Jan 2023to 30 Sep 2025
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 30 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Turkey (Türkiye)1 site
  • Ege UnIversty

    Bornova, İzmir, 35030

Other trials in Turkey (Türkiye)

About this study

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.

Read the detailed description

Breast cancer is the most commonly diagnosed cancer in women, accounting for approximately 12% of cancer cases. According to the World Health Organization, 2.3 million women were diagnosed with breast cancer in 2020, and 685,000 people lost their lives. Breast cancer ranks second in cancer death statistics in Turkey. Approximately 15,000 women are diagnosed with breast cancer every year. The incidence is highest in the 25-49 age group with 35.6%.The increase in breast cancer prevalence rates in the world and in Turkey and the decreasing age of onset show how important it is to increase public awareness of this issue and their participation in screening programs. Today, 30-50% of cancer can be prevented. This can be achieved by avoiding risk factors and implementing existing evidence-based prevention strategies. Some of the prevention strategies are; reaching women at risk for breast cancer, early diagnosis, and providing health behaviors through education.

The American Cancer Society states that there are women at high risk for breast cancer, and that factors such as gender, age, history, family history, early menarche, etc. that increase the risk factor should be evaluated In this context, it is necessary to evaluate breast cancer risk status correctly. Models aimed at predicting the risk of developing cancer are useful for implementing prevention strategies such as planning education and providing counseling In Turkey, the 'Breast Cancer Risk Assessment Form' is used for calculations aimed at predicting the risk of developing breast cancer. Thus, the risk status in breast cancer can be determined and early precautions can be taken according to the situation. Early stage diagnosis in breast cancer provides a good prognosis and is of critical importance for long-term survival. In this project, reaching high-risk women in breast cancer using the 'Breast Cancer Risk Assessment Form' and calculating their risk levels is seen as an important gain.

The probability of recovery is high for many early-diagnosed cancers. Especially considering that the age at which breast cancer screening begins varies among high-risk women, reaching these high-risk women at the right time in society, ensuring that individual risk is calculated and perceived correctly, is important for gaining health behaviors appropriate for early diagnosis methods. In this direction; It is necessary to gain health behaviors such as early diagnosis methods such as breast self-examination (BSE), clinical breast examination (CBE) and mammography to high-risk women in breast cancer through planned education. Another gain of this project is to gain health behaviors in early diagnosis in breast cancer through planned education.

Global Breast Cancer Initiative (GBCI); recommends disseminating early diagnosis methods and creating breast cancer awareness for health promotion and development Awareness can only be achieved through educational activities carried out within the framework of a developed plan. It is stated that women have information needs (treatment, breast cancer symptoms and breast self-examination) and support needs (learning to do BSE, women's concerns for themselves and their relatives, having professional breast examination at the health institution) in breast cancer prevention. In this context, the importance of planned education is increasing in order to provide information and support needs in breast cancer prevention. The importance of providing planned education to women is also emphasized in many studies. The selection of the method in the planned education should be in a way that will meet the information and support needs. Especially BSE; It becomes more permanent when it provides experience-based learning through 'doing, living' on a breast model. In this project, especially with a planned education based on 'doing, living' experience-based learning, providing women at high risk of breast cancer with the experience of feeling and finding breast cancer signs and symptoms on a 'breast model', experiencing pathological formations and performing BSE examination skills with steps, and ensuring the permanence of health behavior is seen as an important gain.

On the other hand, it is stated that the health belief status and fatalism approach of the individual are also important for the early diagnosis behaviors of breast cancer to be permanent. These health beliefs can be preventive or supportive in some cases. Fatalism and health belief are important predictors in the potential emergence of the behavior.Therefore, knowing and measuring the health belief and fatalism status of women is important for women at high risk of breast cancer. Another output of the project is the measurement of the health beliefs and fatalism status of women at high risk of breast cancer.

Being tested
IMPLEMENTATION OF A PLANNED EDUCATION PROGRAM ON HEALTH BELIEF MODEL AND FATUALIST TENDENCIES IN WOMEN AT HIGH RISK OF BREAST CANCER
Keywords
breast cancer, health belief model, fatalism, public health nursing, nurse, early diagnosis of cancer
Medical subject headings
Breast Neoplasms, Health Behavior, Breast Self-Examination

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • IMPLEMENTATION OF A PLANNED EDUCATION PROGRAM ON HEALTH BELIEF MODEL AND FATUALIST TENDENCIES IN WOMEN AT HIGH RISK OF BREAST CANCERBehavioural

    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

Study groups in NCT06690320
Study groupRoleWhat they receive
control groupNo interventionNo 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 groupExperimentalA one-session planned training program will be applied to the experimental group.
Receives: Behavioral: IMPLEMENTATION OF A PLANNED EDUCATION PROGRAM ON HEALTH BELIEF MODEL AND FATUALIST TENDENCIES IN WOMEN AT HIGH RISK OF BREAST CANCER

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 15 days

Secondary outcomes (1)
  1. Powe's Breast Cancer Fatalism Scale

    Powe's Breast Cancer Fatalism Scale will be applied to the experimental and control groups. The scale consists of 11 items. It is answered as yes / no. A "yes" answer is calculated as 1 point, a "no" answer is calculated as 0 points.

    Measured: 15 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Nov 2024
  2. Study start17 Jan 2023
  3. Primary completion30 Dec 2024 (estimated)
  4. Study completion30 Sep 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Screening
Allocation
Randomised
Intervention model
Parallel groups
Model description
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.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
72 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06690320
Sponsor's protocol ID
23-4.1T/56
Status last verified
Oct 2024
First submitted
20 Oct 2024
Last updated
15 Nov 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 23167367
  • 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.

    PubMed 24969891
  • 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.

    PubMed 33538338

Questions about this trial

What is this clinical trial studying?

A study testing IMPLEMENTATION OF A PLANNED EDUCATION PROGRAM ON HEALTH BELIEF MODEL AND FATUALIST TENDENCIES IN WOMEN AT HIGH RISK OF BREAST CANCER in people with Breast Cancer and Health Behavior, run by Ege University at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: enrolling by invitation, as of the sponsor's last update on 15 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Champion's Health Belief Model Scale (time frame: 15 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06690320, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Nov 2024; AzTrials last refreshed its copy on 8 Nov 2026.

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