Women's HealthNCT06543147
Effect of Education on Breast Cancer Fear and Health Beliefs
A study testing breast cancer and breast self- examination education in people with Women's Health and Health Education, run by Kırklareli University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 20 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Women's Health, Health Education
- What is being tested?
- breast cancer and breast self- examination education
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 17 Mar 2018to 30 Apr 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 20 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- having a history of breast cancer
- having a communication barrier
- being in the lactation process
- not volunteering to participate in the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Education About Breast Cancer and Breast Self- Examination on Breast Cancer Fear and Health Beliefs: Randomized Controlled Trial
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.
Read more
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.
Read the 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
- Conditions
- Women's Health, Health Education
- Being tested
- breast cancer and breast self- examination education
- Keywords
- Breast self examination, health belief model, breast cancer, breast cancer fear
- Medical subject headings
- Health Education, Breast Self-Examination, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
breast cancer and breast self- examination educationOther
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. 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.
| Study group | Role | What they receive |
|---|---|---|
| experimental group | Experimental | There are 79 female participants in this group. After the pre-test, participants in the experimental group were given breast cancer and breast self-examination training. After the training, they were reminded to do breast self-examination by phone for six months. The post-test was administered six months later. Receives: Other: breast cancer and breast self- examination education |
| Control Group | No intervention | There are 80 female participants in this group. A pre-test was applied to the participants in the control group. The participants in the experimental group were given an intervention for six months, while the participants in the control group were not. A post-test was applied after six months. 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Champion Health Belief Model Scale
The CHBMS consists of 6 subscales and 42 items; susceptibility perception of the perceived individual risks of catching breast cancer (3 items), seriousness perception about the perceived degree of individual threat from breast cancer (7 items), benefits perception expressing advantages related to BSE (4 items), barriers perception about perceived obstacles related to BSE (11 items), confidence expressing perceived individual competence in the ability to identify an abnormal breast mass during BSE (10 items) and health motivation subscale (7 items). Each subscale is evaluated separately and total points including the whole scale are not calculated. Women receiving low points for the barrier subscale and high points from the other subscales show positive attitudes and beliefs related to breast cancer and BSE
Measured: Six mounth
Champion Breast Cancer Fear Scale
Items on the scale investigate emotions like fear, upset, tension, irritation, restlessness, and worry and situations like depression or increased heart rate when breast cancer is considered. The scale contains 8 items and has a five-point Likert response. Responses to the scale are "definitely disagree" 1 point, "disagree" 2 points, "undecided" 3 points, "agree" 4 points and "completely disagree" 5 points. The lowest points that can be obtained from the scale is 8 with the highest points of 40. High points show high levels of fear about breast cancer. For definition of fear levels to breast cancer low levels of fear are 8-15 points, moderate levels of fear are 16-23 points and high levels of fear are 24-40 points.
Measured: Six mounth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2024
- Study start17 Mar 2018
- Primary completion1 Oct 2018
- Study completion30 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Women's HealthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 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.
- Masking
- None (open label)
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kırklareli University
- Sponsor type
- University, hospital or other
- Collaborators
- Ordu University Scientific Research Projects Coordination Department
- Responsible party
- Principal investigator, Nermin Kayar, Kırklareli University
- Investigators
- nermin kayar, Principal investigator, nerminkayar@klu.edu.tr
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06543147
- Sponsor's protocol ID
- Nermin KAYAR
- Other IDs
- 2018/B-1838
- Status last verified
- Aug 2024
- First submitted
- 3 Aug 2024
- Last updated
- 7 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Clinical data are not publicly available due to privacy laws. Questions regarding data can be directed to the corresponding author.
Publications
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.
PubMed 17235224Champion 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.
PubMed 15367754
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Education About Breast Cancer and Breast Self- Examination on Breast Cancer Fear and Health Beliefs: Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06543147
- Acronym / sponsor ID
- Nermin KAYAR
- Conditions
- Women's Health, Health Education
- Keywords
- Breast self examination, health belief model, breast cancer, breast cancer fear
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Kırklareli UniversityUniversity, hospital or other
- Collaborators
- Ordu University Scientific Research Projects Coordination Department
- Study start
- 17 Mar 2018 (actual)
- Primary completion
- 1 Oct 2018 (actual)
- Study completion
- 30 Apr 2019 (actual)
- First posted
- 7 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| experimental group | Experimental | Other: breast cancer and breast self- examination educationThere are 79 female participants in this group. After the pre-test, participants in the experimental group were given breast cancer and breast self-examination training. After the training, they were reminded to do breast self-examination by phone for six months. The post-test was administered six months later. |
| Control Group | No intervention | –There are 80 female participants in this group. A pre-test was applied to the participants in the control group. The participants in the experimental group were given an intervention for six months, while the participants in the control group were not. A post-test was applied after six months. 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 |
Who may qualify
- Ages
- 20 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- having a history of breast cancer
- having a communication barrier
- being in the lactation process
- not volunteering to participate in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| breast cancer and breast self- examination educationThe 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. 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. | Other | experimental group |
Primary outcome
Champion Health Belief Model Scale
Time frame: Six mounth
The CHBMS consists of 6 subscales and 42 items; susceptibility perception of the perceived individual risks of catching breast cancer (3 items), seriousness perception about the perceived degree of individual threat from breast cancer (7 items), benefits perception expressing advantages related to BSE (4 items), barriers perception about perceived obstacles related to BSE (11 items), confidence expressing perceived individual competence in the ability to identify an abnormal breast mass during BSE (10 items) and health motivation subscale (7 items). Each subscale is evaluated separately and total points including the whole scale are not calculated. Women receiving low points for the barrier subscale and high points from the other subscales show positive attitudes and beliefs related to breast cancer and BSE
Champion Breast Cancer Fear Scale
Time frame: Six mounth
Items on the scale investigate emotions like fear, upset, tension, irritation, restlessness, and worry and situations like depression or increased heart rate when breast cancer is considered. The scale contains 8 items and has a five-point Likert response. Responses to the scale are "definitely disagree" 1 point, "disagree" 2 points, "undecided" 3 points, "agree" 4 points and "completely disagree" 5 points. The lowest points that can be obtained from the scale is 8 with the highest points of 40. High points show high levels of fear about breast cancer. For definition of fear levels to breast cancer low levels of fear are 8-15 points, moderate levels of fear are 16-23 points and high levels of fear are 24-40 points.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2024.
- Background: PubMed 17235224Karayurt 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.
- Results publication: PubMed 15367754Champion 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.
- Individual participant dataSharing planned: No. Clinical data are not publicly available due to privacy laws. Questions regarding data can be directed to the corresponding author.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
nermin kayar principal investigator
nerminkayar@klu.edu.tr
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing breast cancer and breast self- examination education in people with Women's Health and Health Education, run by Kırklareli 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 5 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: finished, as of the sponsor's last update on 7 Aug 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 Health Belief Model Scale (time frame: Six mounth). The study lists 2 primary outcomes in all. 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 NCT06543147, which also lists 2 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 7 Aug 2024.