Clinical trial NCT06543147: Effect of Education on Breast Cancer Fear and Health Beliefs
Official title: The Effect of Education About Breast Cancer and Breast Self- Examination on Breast Cancer Fear and Health Beliefs: Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Women's Health
Health Education
Keywords: Breast self examination
health belief model
breast cancer
breast cancer fear
Lead sponsor: Kırklareli University
Sponsor class: OTHER
Collaborators: name: Ordu University Scientific Research Projects Coordination Department
First posted: 2024-08-07
Enrollment: 160
Sex: FEMALE
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Administering a pre-test to the participants in the experimental and control groups. After the pre-test, the participants in the experimental group were given breast cancer and breast self-examination training, brochure distribution, and reminders of breast self-examination by phone for six months. They administered a post-test to the participants in the experimental and control groups six months later.
Primary purpose: SCREENING

Brief summary: The study was conducted to determine the effect of breast cancer and breast self-examination (BSE) education on breast cancer fear and health beliefs. The main questions it aims to answer are:

H1: Breast cancer and BSE training given to women will affect the health beliefs of women.

H2: Breast cancer and BSE training given to women will affect the fear of breast cancer among women.

H3: Breast cancer and BSE training given to women will affect the information and behaviour in relation to breast cancer screening among women.

Researchers divided participants into experimental and control groups to examine the effects of breast cancer and breast self-examination education on breast cancer fear and health beliefs. The experimental group received education about breast cancer and breast self-examination and was reminded to perform breast self-examination by phone for six months.

Detailed description: Before beginning the research, women were informed about the aim, duration, and procedures during the research and they were included in the research after written consent was obtained from women accepting participation. Then pre-test data were collected. The collection of data in the research began on 16 October 2017.

In the first stage of the research, pre-test data were collected using the questionnaire form, Champion Health Belief Model Scale, Champion Breast Cancer Fear Scale, and face-to-face interview method, and women were asked to fill out the forms themselves. After the pre-test data were collected, the women were divided into experimental and control groups using a single-blind randomized method.

In the second stage of the research, women in the experimental group were given education about breast cancer and BSE. Slide presentations used during training provided information about breast anatomy and physiology, breast cancer symptoms and risk factors, early diagnosis methods for breast cancer and breast cancer screening programs, and barriers to breast cancer screening programs were discussed. In addition to slide presentations about breast cancer and BSE, women were also given BSE training on a breast examination mannequin and given brochures after training. The training lasted 40-50 minutes. Training was given in groups of 7-9 people and was completed from 2 April 2018 to 30 April 2018. After women in the experimental group were given training, they were called by telephone once per month until 6 months and reminded about doing BSE.

In the final stage of the research, a post-test was applied to women in the experiment and control groups six months after the first training. The posttest applied the questionnaire, CHBMS, and CBCFS for a second time. Attempts were made to determine the effect of the training and counseling on breast cancer health beliefs and fear of breast cancer.

Based on the principle of sufficient and accurate care, women in the control group were given training about breast cancer and BSE in groups of 7-9 people after posttest data were collected and given brochures at the end of training

Eligibility criteria: Inclusion Criteria:

* Being over 20 years old
* not having a history of breast cancer
* not being in the lactation process
* not having a communication barrier
* volunteering to participate in the study

Exclusion Criteria:

* having a history of breast cancer
* having a communication barrier
* being in the lactation process
* not volunteering to participate in the study

Primary outcomes:
measure: Champion Health Belief Model Scale
timeFrame: Six mounth
measure: Champion Breast Cancer Fear Scale
timeFrame: Six mounth
Secondary outcomes:
Other outcomes:
Locations:
city: Ordu
country: Turkey
facility: Ordu University
Study officials:
affiliation: nerminkayar@klu.edu.tr
name: nermin kayar
role: PRINCIPAL_INVESTIGATOR
References:
citation: Karayurt O, Dramali A. Adaptation of Champion's Health Belief Model Scale for Turkish women and evaluation of the selected variables associated with breast self-examination. Cancer Nurs. 2007 Jan-Feb;30(1):69-77. doi: 10.1097/00002820-200701000-00013.
citation: Champion VL, Skinner CS, Menon U, Rawl S, Giesler RB, Monahan P, Daggy J. A breast cancer fear scale: psychometric development. J Health Psychol. 2004 Nov;9(6):753-62. doi: 10.1177/1359105304045383.