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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03398057
Other study ID # AAAAlameer
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 20, 2017
Est. completion date March 15, 2018

Study information

Verified date May 2018
Source Saudi Commission for Health Specialties, Saudi Arabia
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.


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?


Recruitment information / eligibility

Status Completed
Enrollment 150
Est. completion date March 15, 2018
Est. primary completion date February 28, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 20 Years and older
Eligibility Inclusion Criteria:

- 20 years. No personal history of BC. No first degree relative of BC. Not being pregnant or breast feeding. Ability to understand questionnaire

Exclusion Criteria:

Refused to give informed consent. Sever medical problem prevent participation.

Study Design


Related Conditions & MeSH terms

  • Breast Neoplasms
  • Effect of Health Education Regarding Screening Tools of Breast Cancer

Intervention

Other:
Health education
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 group
Placebo health education (pamphlets) will be applied to this group participants during study.

Locations

Country Name City State
Saudi Arabia Jazan Area Schools Jazan

Sponsors (1)

Lead Sponsor Collaborator
Anwar Ali Ahmad Alameer

Country where clinical trial is conducted

Saudi Arabia, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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.
Researchers assessed the improvement of participants knowledge and practice six weeks after applying of health education programs in both groups.
Primary 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.
Researchers assessed the improvement of participants knowledge and practice three months after applying of health education programs in both groups.
Secondary 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.
At the beginning of study, before applying of health education in both groups