Effect of Health Education Regarding Screening Tools of Breast CancerNCT03398057
Effect of Health Education on Female Teachers' Knowledge and Practices Regarding Early Breast Cancer Detection and Screening in the Jazan Area: A Quasi-Experimental Study
A study testing Health education in people with Effect of Health Education Regarding Screening Tools of Breast Cancer, run by Anwar Ali Ahmad Alameer at 1 site in Saudi Arabia.
Trial summary
The purpose of this study is to assess the effectiveness of health education in improving the knowledge and practices of female teachers regarding screening tools and the early detection of breast cancer. 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
- Effect of Health Education Regarding Screening Tools of Breast Cancer
- What is being tested?
- Health education
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 20 Nov 2017to 15 Mar 2018
- 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
- 20 years. No personal history of BC. No first degree relative of BC. Not being pregnant or breast feeding. Ability to understand questionnaire
Who cannot join
- Refused to give informed consent. Sever medical problem prevent participation.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to assess the effectiveness of health education in improving the knowledge and practices of female teachers regarding screening tools and the early detection of breast cancer.
Read the detailed description
A two-group quasi-experimental design was conducted among 150 female teachers, who were selected from 75 schools of the Jazan General Administration of Education. Schools were chosen by a simple cluster randomization method. Schools were non-randomly assigned to either the intervention or control group. Eligible participants were recruited by a simple randomization method, proportional to the total number of teachers at each school. Those in the intervention group (n=75 teachers) were compared to the control group (n=75 teachers) at baseline, as well as at 6 weeks and 3 months post-intervention.
Study aim:
Assess effectiveness of health education on improving knowledge and practices regarding Breast cancer(BC) early detection and screening tools among female teachers after six weeks, three months in health education group in compare with control group.
Specific objectives:
Estimate level of awareness among female teachers regarding knowledge and practices of BC early detection and screening tools in Jazan area schools.
Measure the impact of health education on female teachers knowledge and practices regarding BC early detection and screening tools in health education group in compare with control group. So Research questions are:
What is the current awareness level of female teachers in Jazan area schools regarding knowledge and practices of BC early detection and screening tools? Does health education improve knowledge and practices regarding BC early detection and screening tools among female teachers in Jazan area schools in health education group more than control group?
- Being tested
- Health education, Control group
- Keywords
- Breast cancer screening; health education; breast self-examination; clinical breast examination; mammography.
- Medical subject headings
- Health Education, Breast Self-Examination
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Health educationOther
SHEP included a comprehensive lecture about BC, with a generally deep focus on detection and screening tools, which were illustrated by a PowerPoint presentation with pictures and videos. The program also included a practical session about BSE (on breast silicon model). At the end of SHEP, a focused group discussion was conducted to answer participants' questions, and to discuss important barriers regarding BSE practice and visiting primary health care centers or clinics to undergo CBE and mammography. Different scientific and administrative solutions were discussed. SHEP materials were distributed as a hard copy (booklet) and in electronic format (CD) for all participants in the health education group at the end of training.
Control groupOther
Placebo health education (pamphlets) will be applied to this group participants during study.
| Study group | Role | What they receive |
|---|---|---|
| Health education group(intervention group) | Experimental | Standardized heath education Program(SHEP) applied to this group participants . Receives: Other: Health education |
| Control group | Placebo comparator | Placebo health education. Receives: Other: Control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effectiveness of health education on improving knowledge and practice regarding BC screening tools in health education group(75 female teachers) VS control group(75 female teachers)
Researchers assessed knowledge regarding BC detection and screening tools,through modified version of BCK test questionnaire which originally developed by Kathryn L.McCance,1989, USA, it contains nineteen questions. BSE knowledge and practices were assessed through BSE scale which developed by Champion,V.L.,1984, it contains fifteen questions.
Researchers assessed clinical breast examination (CBE) and mammography practice through questions from ''Detection of Breast Cancer: Knowledge, Attitude, and Practice of Family Health Strategy Women'' questionnaire by de Oliveria RD and ''Intervention Tailoring for Chinese American Women: Comparing the Effect of Two Video on Knowledge, Attitudes, Intentions to Obtain a Mammogram'' questionnaire by Wang JH, it contains 4 questions.All previous questionnaires are valid and reliable instruments.
Measured: Researchers assessed the improvement of participants knowledge and practice six weeks after applying of health education programs in both groups.
Effectiveness of health education on improving knowledge and practice regarding BC screening tools in health education group(75 female teachers) VS control group(75 female
Researchers assessed knowledge regarding BC detection and screening tools,through modified version of BCK test questionnaire which originally developed by Kathryn L.McCance,1989, USA, it contains nineteen questions. BSE knowledge and practices were assessed through BSE scale which developed by Champion,V.L.,1984, it contains fifteen questions.
Researchers assessed clinical breast examination (CBE) and mammography practice through questions from ''Detection of Breast Cancer: Knowledge, Attitude, and Practice of Family Health Strategy Women'' questionnaire by de Oliveria RD and ''Intervention Tailoring for Chinese American Women: Comparing the Effect of Two Video on Knowledge, Attitudes, Intentions to Obtain a Mammogram'' questionnaire by Wang JH, it contains 4 questions.All previous questionnaires are valid and reliable instruments.
Measured: Researchers assessed the improvement of participants knowledge and practice three months after applying of health education programs in both groups.
Secondary outcomes (1)
Baseline knowledge and practice regarding BC screening tools in health education group(75 female teachers) VS control group(75 female teachers)
Researchers assessed knowledge regarding BC detection and screening tools,through modified version of BCK test questionnaire which originally developed by Kathryn L.McCance,1989, USA, it contains nineteen questions. BSE knowledge and practices were assessed through BSE scale which developed by Champion,V.L.,1984, it contains fifteen questions.
Researchers assessed clinical breast examination (CBE) and mammography practice through questions from ''Detection of Breast Cancer: Knowledge, Attitude, and Practice of Family Health Strategy Women'' questionnaire by de Oliveria RD and ''Intervention Tailoring for Chinese American Women: Comparing the Effect of Two Video on Knowledge, Attitudes, Intentions to Obtain a Mammogram'' questionnaire by Wang JH, it contains 4 questions.All previous questionnaires are valid and reliable instruments.
Measured: At the beginning of study, before applying of health education in both groups
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2018
- Study start20 Nov 2017
- Primary completion28 Feb 2018
- Study completion15 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Effect of Health Education Regarding Screening Tools of Breast CancerStudies 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
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Anwar Ali Ahmad Alameer
- Sponsor type
- Other government
- Responsible party
- Sponsor-investigator, Anwar Ali Ahmad Alameer, Saudi Commission for Health Specialties, Saudi Arabia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03398057
- Sponsor's protocol ID
- AAAAlameer
- Status last verified
- May 2018
- First submitted
- 28 Dec 2017
- Last updated
- 7 May 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: After analysis of data, we will destroy all individual data to save participants privacy.
Publications
Alameer A, Mahfouz MS, Alamir Y, Ali N, Darraj A. Effect of Health Education on Female Teachers' Knowledge and Practices Regarding Early Breast Cancer Detection and Screening in the Jazan Area: a Quasi-Experimental Study. J Cancer Educ. 2019 Oct;34(5):865-870. doi: 10.1007/s13187-018-1386-9.
PubMed 29951902
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Health Education on Female Teachers' Knowledge and Practices Regarding Early Breast Cancer Detection and Screening in the Jazan Area: A Quasi-Experimental Study
- ClinicalTrials.gov ID
- NCT03398057
- Acronym / sponsor ID
- AAAAlameer
- Keywords
- Breast cancer screening; health education; breast self-examination; clinical breast examination; mammography.
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Anwar Ali Ahmad AlameerOther government
- Study start
- 20 Nov 2017 (actual)
- Primary completion
- 28 Feb 2018 (actual)
- Study completion
- 15 Mar 2018 (actual)
- First posted
- 12 Jan 2018 (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 purpose of this study is to assess the effectiveness of health education in improving the knowledge and practices of female teachers regarding screening tools and the early detection of breast cancer.
Detailed description
A two-group quasi-experimental design was conducted among 150 female teachers, who were selected from 75 schools of the Jazan General Administration of Education. Schools were chosen by a simple cluster randomization method. Schools were non-randomly assigned to either the intervention or control group. Eligible participants were recruited by a simple randomization method, proportional to the total number of teachers at each school. Those in the intervention group (n=75 teachers) were compared to the control group (n=75 teachers) at baseline, as well as at 6 weeks and 3 months post-intervention.
Study aim:
Assess effectiveness of health education on improving knowledge and practices regarding Breast cancer(BC) early detection and screening tools among female teachers after six weeks, three months in health education group in compare with control group.
Specific objectives:
Estimate level of awareness among female teachers regarding knowledge and practices of BC early detection and screening tools in Jazan area schools.
Measure the impact of health education on female teachers knowledge and practices regarding BC early detection and screening tools in health education group in compare with control group. So Research questions are:
What is the current awareness level of female teachers in Jazan area schools regarding knowledge and practices of BC early detection and screening tools? Does health education improve knowledge and practices regarding BC early detection and screening tools among female teachers in Jazan area schools in health education group more than control group?
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Health education group(intervention group) | Experimental | Other: Health educationStandardized heath education Program(SHEP) applied to this group participants . |
| Control group | Placebo comparator | Other: Control groupPlacebo health education. |
Who may qualify
- Ages
- 20 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 20 years. No personal history of BC. No first degree relative of BC. Not being pregnant or breast feeding. Ability to understand questionnaire
Key exclusion criteria (1 listed)
- Refused to give informed consent. Sever medical problem prevent participation.
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 |
|---|---|---|
| Health educationSHEP included a comprehensive lecture about BC, with a generally deep focus on detection and screening tools, which were illustrated by a PowerPoint presentation with pictures and videos. The program also included a practical session about BSE (on breast silicon model). At the end of SHEP, a focused group discussion was conducted to answer participants' questions, and to discuss important barriers regarding BSE practice and visiting primary health care centers or clinics to undergo CBE and mammography. Different scientific and administrative solutions were discussed. SHEP materials were distributed as a hard copy (booklet) and in electronic format (CD) for all participants in the health education group at the end of training. | Other | Health education group(intervention group) |
| Control groupPlacebo health education (pamphlets) will be applied to this group participants during study. | Other | Control group |
Primary outcome
Effectiveness of health education on improving knowledge and practice regarding BC screening tools in health education group(75 female teachers) VS control group(75 female teachers)
Time frame: Researchers assessed the improvement of participants knowledge and practice six weeks after applying of health education programs in both groups.
Researchers assessed knowledge regarding BC detection and screening tools,through modified version of BCK test questionnaire which originally developed by Kathryn L.McCance,1989, USA, it contains nineteen questions. BSE knowledge and practices were assessed through BSE scale which developed by Champion,V.L.,1984, it contains fifteen questions. Researchers assessed clinical breast examination (CBE) and mammography practice through questions from ''Detection of Breast Cancer: Knowledge, Attitude, and Practice of Family Health Strategy Women'' questionnaire by de Oliveria RD and ''Intervention Tailoring for Chinese American Women: Comparing the Effect of Two Video on Knowledge, Attitudes, Intentions to Obtain a Mammogram'' questionnaire by Wang JH, it contains 4 questions.All previous questionnaires are valid and reliable instruments.
Effectiveness of health education on improving knowledge and practice regarding BC screening tools in health education group(75 female teachers) VS control group(75 female
Time frame: Researchers assessed the improvement of participants knowledge and practice three months after applying of health education programs in both groups.
Researchers assessed knowledge regarding BC detection and screening tools,through modified version of BCK test questionnaire which originally developed by Kathryn L.McCance,1989, USA, it contains nineteen questions. BSE knowledge and practices were assessed through BSE scale which developed by Champion,V.L.,1984, it contains fifteen questions. Researchers assessed clinical breast examination (CBE) and mammography practice through questions from ''Detection of Breast Cancer: Knowledge, Attitude, and Practice of Family Health Strategy Women'' questionnaire by de Oliveria RD and ''Intervention Tailoring for Chinese American Women: Comparing the Effect of Two Video on Knowledge, Attitudes, Intentions to Obtain a Mammogram'' questionnaire by Wang JH, it contains 4 questions.All previous questionnaires are valid and reliable instruments.
1 secondary outcome
Baseline knowledge and practice regarding BC screening tools in health education group(75 female teachers) VS control group(75 female teachers)
Time frame: At the beginning of study, before applying of health education in both groups
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 May 2018.
- Derived from this study: PubMed 29951902Alameer A, Mahfouz MS, Alamir Y, Ali N, Darraj A. Effect of Health Education on Female Teachers' Knowledge and Practices Regarding Early Breast Cancer Detection and Screening in the Jazan Area: a Quasi-Experimental Study. J Cancer Educ. 2019 Oct;34(5):865-870. doi: 10.1007/s13187-018-1386-9.
- Individual participant dataSharing planned: No. After analysis of data, we will destroy all individual data to save participants privacy.
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Health education in people with Effect of Health Education Regarding Screening Tools of Breast Cancer, run by Anwar Ali Ahmad Alameer at 1 site in Saudi Arabia.
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 1 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 May 2018. 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 Saudi Arabia. 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. Some participants in this study may receive a placebo. 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?
Effectiveness of health education on improving knowledge and practice regarding BC screening tools in health education group(75 female teachers) VS control group(75 female teachers) (time frame: Researchers assessed the improvement of participants knowledge and practice six weeks after applying of health education programs in both groups.). 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 NCT03398057, which also lists 1 linked publication.
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 May 2018.