This study is a single blind field trial with control group to evaluate effectiveness of the health education models intervention by peer group on breast cancer screening in women with positive family history. Target group are women and daughters with family history of breast cancer. Total sample size is 100. Sample size will be collected among women with a first or second degree relative of breast cancer that are referred to Saied Shohola Hospital in Isfahan. First questionnaire will be filled by questioner for women who filled the consent. If women are in pre contemplation, contemplation or relapse stages of Tran's theoretical model of breast cancer screening will be entered in the study. Then women will be allocated to intervention and control groups by computer randomized soft ware. We will choose some women with action or maintenance stages of breast cancer screening as educators in this step. At the beginning of the intervention educators will be educated by health expert on health belief model. In the second stage intervention group will be educated by educators. Immediate and 3 months after the intervention questionnaire will be filled by control and intervention groups to evaluate their knowledge, health beliefs and screening practice again.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015051921447N2
Registration date:2015-07-03, 1394/04/12
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-07-03, 1394/04/12
Registrant information
Name
Fariba Fathollahi Dehkordi
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 3792 2542
Email address
f_fathollahi@med.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Isfahan University of Medical Sciences
Expected recruitment start date
2015-05-26, 1394/03/05
Expected recruitment end date
2015-09-11, 1394/06/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effectiveness of the health education models intervention by peer group on breast cancer screening in women with positive family history
Public title
Effectiveness of education intervention on breast cancer screening
Purpose
Screening
Inclusion/Exclusion criteria
Inclusion criteria: history of breast cancer in first or second degree relative; stay on pre contemplation, contemplation or relapse stages for education receiver; stay on action or maintenance stages for educators; tendency to participate in the study
Exclusion criteria: not complete more than 20% of questionnaire; not participate in more than on session; not tendency to continue the study; breast cancer development during the study
Age
From 20 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics of Isfahan University of Medical Sciences
Street address
Isfahan University of Medical Sciences, Hezar Jerib Street
City
Isfahan
Postal code
8174673461
Approval date
2015-05-24, 1394/03/03
Ethics committee reference number
mui.rec394130
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
Clinical breast examination
Timepoint
Before and 3 months after intervention
Method of measurement
questionarie
2
Description
Mammography screening
Timepoint
Before and 3 months after intervention
Method of measurement
questionarie
Secondary outcomes
1
Description
Knowledge about breast cancer and screening
Timepoint
Before, immediate after and 3 moth after the intervention
Method of measurement
questionarie
2
Description
Health belief about breast cancer and screening
Timepoint
Before, immediate after and 3 moth after the intervention
Method of measurement
questionarie
3
Description
Distribution of breast cancer screening stage of change excluding maintenance stage
Timepoint
Before, immediate after and 3 moth after the intervention
Method of measurement
questionarie
Intervention groups
1
Description
We have an educational intervention in three sessions for intervention group. Intervention group will be educated with individuals in action or maintenance stage of breast cancer screening behavior. These sessions will be held on health belief model to increase participant perceived sensitivity and intensity about breast cancer, their knowledge about breast cancer signs, symptoms and risk factors, early detection methods, perceived benefit and barriers. In all sessions educator will tell about her successful experiences. At the end of the intervention we will give an education program booklet and CD to participants.
Category
Early detection
2
Description
To preserving ethical principles, we give an educational program booklet and CD at the end of study.
Category
Early detection
Recruitment centers
1
Recruitment center
Name of recruitment center
Saied Shohada hospital
Full name of responsible person
Simin Hematti
Street address
After Shiri Bridge, Mottahari Street
City
Isfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for research of Isfahan University of Medical Sciences
Full name of responsible person
Mahdi Nematbakhsh
Street address
Vice Chancellor for research, building number 4, Isfan University of Medical Science, Hezar Jerib street
City
Isfahan
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 Isfahan 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
Isfahan University of Medical Sciences
Full name of responsible person
Ziba Farajzadegan
Position
Professor
Other areas of specialty/work
Street address
Community Medicine Group, Isfahan School of Medicine, Isfahan University of Medical Sciences, Hezar Jerib street
City
Isfahan
Postal code
Phone
+98 31 3792 2542
Fax
Email
farajzadegan@med.mui.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Ziba Farajzadegan
Position
Professor
Other areas of specialty/work
Street address
Community Medicine Group, School of Medicine, Isfahan University of Medical Sciences, Hezar Jerib street
City
Isfahan
Postal code
Phone
+98 31 3792 2542
Fax
Email
farajzadegan@med.mui.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Fariba Fathollahi
Position
Resident of Community Medicine
Other areas of specialty/work
Street address
Community Medicine Group, School of Medicine, Isfahan University of Medical Sciences, Hezar Jerib street
City
Isfahan
Postal code
Phone
+98 31 3792 2542
Fax
Email
f_fathollahi@med.mui.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)