Protocol summary

Summary
Breast cancer is the most common cancer in women worldwide and the second cause of death among women with 35-55 years old. A way to early detection is mammography. This study compared the effectiveness of two different educational methods based on Health Belief Model on teachers' Mammography. This study is a random clinical trial which has been carried out since December to March, 2015 in 21 elementary schools in Bushehr, a southwestern province in Iran. The study sample includes 180 female elementary school teachers. The inclusion criteria were women older than 40 years old, not having breast cancer or other types of cancers, not having family history of breast cancer, not having breast biopsy experience and mammography in the past three years. Since participants in three groups can flaw educational effectiveness's on each groups with receive information through educational method, it chose some schools for each of three groups (group education, multimedia education and control) through random allocation with lottery of elementary schools to provide sixty people for each group. People were divided to multimedia education, group education and control group. Both multimedia and group education received education based on Health Belief Model (HBM). The control group received no education. The people completed the Champion questionnaire that containing demographic questions, knowledge and constructs of HBM, before, immediate and three months after educational and performance question was completed before beginning the training and three months later.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2014112620105N1
Registration date: 2015-08-17, 1394/05/26
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2015-08-17, 1394/05/26
Registrant information
Name
Esmat Heydari
Name of organization / entity
Bushehr University of Medical Sciences, Bushehr, Iran
Country
Iran (Islamic Republic of)
Phone
+98 77 3345 0069
Email address
es.heydari@bpums.ac.ir
Recruitment status
Recruitment complete
Funding source
Bushehr University of Medical Sciences, Bushehr, Iran
Expected recruitment start date
2014-12-22, 1393/10/01
Expected recruitment end date
2015-03-19, 1393/12/28
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison between group and multimedia education based on Health Belief Model on mammography in teachers of Bushehr
Public title
The impact of training for Mammography to detect early breast cancer
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion Criteria: They should not have breast or other types of cancers; their first degree relatives do not have breast cancer; they should not have breast biopsy experience; they should not have mammography experience in the past three years.
Age
From 40 years old to 65 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 180
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Bushehr University of Medical Sciences
Street address
Bushehr University of Medical Sciences, Salman Farsi St, Bahmani, Bushehr, Iran
City
Bushehr
Postal code
7514633341
Approval date
2014-11-17, 1393/08/26
Ethics committee reference number
B-93-16-12

Health conditions studied

1

Description of health condition studied
Breast Cancer
ICD-10 code
C50
ICD-10 code description
Malignant neoplasm of breast

Primary outcomes

1

Description
Mammography
Timepoint
Before education and 3 months later
Method of measurement
Champion Standard Questionnaire

Secondary outcomes

1

Description
Knowledge of Breast Cancer
Timepoint
Before, immediately and after three months education
Method of measurement
Champion Standard Questionnaire

2

Description
Perceived Susceptibility
Timepoint
Before, immediately and after three months education
Method of measurement
Champion Standard Questionnaire

3

Description
Perceived Severity
Timepoint
Before, immediately and after three months education
Method of measurement
Champion Standard Questionnaire

4

Description
Health Motivation
Timepoint
Before, immediately and after three months education
Method of measurement
Champion Standard Questionnaire

5

Description
Perceived Benefits
Timepoint
Before, immediately and after three months education
Method of measurement
Champion Standard Questionnaire

6

Description
Perceived Barriers
Timepoint
Before, immediately and after three months education
Method of measurement
Champion Standard Questionnaire

Intervention groups

1

Description
The people of group education received two 1-hour group education sessions were based on Health Belief Model
Category
Prevention

2

Description
Education was presented through designed booklet, educational messages and multimedia based on Health Belief Model for using at home in multimedia education group
Category
Prevention

3

Description
The control group received no education
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Education organization of Bushehr City
Full name of responsible person
Faramarz Salimi
Street address
Management 0f Bushehr City Education, Transmission Crossroads, Bushehr, Iran
City
Bushehr

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research of Bushehr University of Medical Sciences
Full name of responsible person
Afshin Ostovar
Street address
Bushehr University of Medical Sciences, Salman Farsi St, Bahmani, Bushehr, Iran
City
Bushehr
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research of Bushehr University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Bushehr University of Medical Sciences, Bushehr, Iran
Full name of responsible person
Azita Noroozi
Position
Ph.D. of Health Education
Other areas of specialty/work
Street address
Bushehr University of Medical Sciences, Salman Farsi St, Bahmani, Bushehr, Iran
City
Bushehr
Postal code
7514633341
Phone
+98 77 3332 2081
Fax
+98 77 3332 3123
Email
azitanoroozi@yahoo.com
Web page address
www.bpums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Bushehr University of Medical Sciences, Bushehr, Iran
Full name of responsible person
Azita Noroozi
Position
Ph.D. of Health Education
Other areas of specialty/work
Street address
Bushehr University of Medical Sciences, Salman Farsi St, Bahmani, Bushehr, Iran
City
Bushehr
Postal code
7514633341
Phone
+98 77 3332 2081
Fax
+98 77 3332 3123
Email
azitanoroozi@yahoo.com
Web page address
www.bpums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Bushehr University of Medical Sciences, Bushehr, Iran
Full name of responsible person
Esmat Heydari
Position
MSc Student of Health Education
Other areas of specialty/work
Street address
Bushehr University of Medical Sciences, Salman Farsi St, Bahmani, Bushehr, Iran
City
Bushehr
Postal code
7514633341
Phone
+98 77 3332 2081
Fax
+98 77 3332 3123
Email
esmat.h.5@gmail.com
Web page address
www.bpums.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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