Investigation of Impact of Theoritical- Based Education in Performing Mammography and Self- Breast Examination in Women Consulting Health Care Center in Isfahan in 96-97
Determining the Effect of the Theory- Based Educational Intervention on Performing Mammogram and Breast Self-Examination in Women Referred to Health Centers in Isfahan
Design
Controlled Clinical Trial
Settings and conduct
Select Two Health Centers in Isfahan and then Perform an Educational Intervention on One of Them
Participants/Inclusion and exclusion criteria
Women 35 Years and Older
Intervention groups
Women 35 years of Age and Older Who are Referred to the Health Care Centers that Are Undergoing Training on This Group, and After the Intervention and three months later, the questionnaire will be filled again.
Main outcome variables
Attitude; Perceived Barrier and Benefits; perceived Severity and Sensitivity; Efficacy; Screening Behaviors
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180830040907N1
Registration date:2019-03-23, 1398/01/03
Registration timing:retrospective
Last update:2019-03-23, 1398/01/03
Update count:0
Registration date
2019-03-23, 1398/01/03
Registrant information
Name
Sakine Ansari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 77 3342 1208
Email address
mosakken_2222@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-08-23, 1397/06/01
Expected recruitment end date
2018-12-21, 1397/09/30
Actual recruitment start date
2018-08-23, 1397/06/01
Actual recruitment end date
2018-12-21, 1397/09/30
Trial completion date
2018-12-21, 1397/09/30
Scientific title
Investigation of Impact of Theoritical- Based Education in Performing Mammography and Self- Breast Examination in Women Consulting Health Care Center in Isfahan in 96-97
Public title
Effect of Education in Performing Mammography and Self- Breast Examination
Purpose
Screening
Inclusion/Exclusion criteria
Inclusion criteria:
Women Older than 35 Years
Ability of Talking
Oral Consent in Control Group and Written Consent in Case Group
Exclusion criteria:
Non Iranian people
History of malignant breast disease
Age
From 35 years old
Gender
Female
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
90
Actual sample size reached:
90
Randomization (investigator's opinion)
Randomized
Randomization description
We will select an area of Isfahan and then select two health centers from that area as a control center and a center as one then randomly selected individuals (from among those who go to the center on a daily basis they do )
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 Isfahan University of Medical Sciences
Street address
Hezarjerib Ave.,Isfahan town
City
Isfahan
Province
Isfehan
Postal code
۷۳۴۶۱-۸۱۷۴۶
Approval date
2017-10-18, 1396/07/26
Ethics committee reference number
ir.mui.rec.1396.3.565
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
Perceived Severity and Sensitivity
Timepoint
Before and After the Intervention, and 3 Months later
Method of measurement
Answer Sheet
2
Description
Breast Cancer Screening Behaviors
Timepoint
Before and After the Intervention, and 3 Months later
Method of measurement
Answer Sheet
3
Description
Efficacy
Timepoint
Before and After the Intervention, and 3 Months later
Method of measurement
Answer Sheet
4
Description
Perceived Benefits and Barriers
Timepoint
Before and After the Intervention, and 3 Months later
Method of measurement
Answer Sheet
5
Description
Attitude
Timepoint
Before and After the Intervention, and 3 Months later
Method of measurement
Answer Sheet
6
Description
Abstract Norm
Timepoint
Before and After the Intervention, and 3 Months later
Method of measurement
Answer Sheet
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Women 35 and Older Referring to Health Centers Who receive educational intervention،Intervention Contains Booklet and Oral Content with visual puctures
Category
Early detection
2
Description
Control group:Women Over 35 and older Referring to Health Centers Who received no intervention
Category
Early detection
Recruitment centers
1
Recruitment center
Name of recruitment center
Baghe Abrisham Health Care Center
Full name of responsible person
Parastoo Golshiri
Street address
Isfahan, Abrisham, Baghe Abrisham Health Care Center
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3669 3985
Fax
Email
golshiri@hlth.mui.ac.ir
2
Recruitment center
Name of recruitment center
Hasan Abad Health Care Center
Full name of responsible person
Parastoo golshiri
Street address
Isfahan, Hasan Abad, Hasan Abad Health Care Center
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3669 3985
Email
golshiri@hlth.mui.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Research Deputy of Isfahan University of Medical Sciences
Full name of responsible person
Shaghayegh Hagh Joo Javanmard
Street address
Hezar Jereb St., Isfahan University of Medical Sciences and Health Services
City
Isfahan
Province
Isfehan
Postal code
۷۳۴۶۱-۸۱۷۴6
Phone
+98 31 3668 8138
Email
sh_haghjoo@med.mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research Deputy of Isfahan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Parastoo Golshiri
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Public Health/Community Medicine
Street address
Hezar Jereb St., Isfahan University of Medical Sciences and Health Services
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3669 3985
Email
golshiri@hlth.mui.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Parastoo Golshiri
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Public Health/Community Medicine
Street address
Faculty of Medicine, Isfahan University of Medical Sciences
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3669 3985
Email
golshiri@hlth.mui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Parastoo Golshiri
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Public Health/Community Medicine
Street address
Faculty of Medicine, Isfahan University of Medical Sciences
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3669 3985
Email
golshiri@hlth.mui.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Not applicable
Title and more details about the data/document
All Data, Including Data Before Intervention and After Intervention
When the data will become available and for how long
Start the Access Period 3 months After Accepting the results
To whom data/document is available
Researchers and Industry Workers
Under which criteria data/document could be used
Any Use Subject to the Mention of the Source is Allowed
From where data/document is obtainable
Sakine.ansari@gmail.com
What processes are involved for a request to access data/document
It will Be Sent About 15 Days After Requesting Data