Protocol summary

Study aim
Effect of an Educational Intervention Based on Protection Motivation Theory on early detection behaviors of breast cancer in women who visit the Community Health Centers.
Design
Semi-experimental study was performed on 20-50 year-old women referred to the health center who Non-randomized controls were divided into control and intervention groups.
Settings and conduct
Community health centers, khalkhal city
Participants/Inclusion and exclusion criteria
Women 20 to 50 years old   Do not breast-feed or during pregnancy   No previous training   do not have breast cancer
Intervention groups
In the intervention group, early detection of cancer was conducted on the basis of the theory and evaluated with the control group that received only traditional education.
Main outcome variables
Early detection of cancer

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20180304038952N1
Registration date: 2019-02-27, 1397/12/08
Registration timing: retrospective

Last update: 2019-02-27, 1397/12/08
Update count: 0
Registration date
2019-02-27, 1397/12/08
Registrant information
Name
LEILA HAKIMI
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 45 3242 4148
Email address
leila_hakimi@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-11-22, 1397/09/01
Expected recruitment end date
2018-12-21, 1397/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of an Educational Intervention Based on Protection Motivation Theory on early detection behaviors of breast cancer in women who visit the Community Health Centers
Public title
The effect of educational intervention based on the theory of early detection of breast cancer
Purpose
Screening
Inclusion/Exclusion criteria
Inclusion criteria:
Reading and writing skills You have no medical education During pregnancy or lactation is not.
Exclusion criteria:
The incomplete company attends training sessions Definitive diagnosis of breast cancer Incomplete questionnaires
Age
From 20 years old to 50 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 90
Randomization (investigator's opinion)
Not 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 Pharmacy and Nursing Schools, Midwifery
Street address
Madani Street
City
khakhal
Province
Ardabil
Postal code
5681756151
Approval date
2017-06-30, 1396/04/09
Ethics committee reference number
IR.SBMU.PHNM.1396.783

Health conditions studied

1

Description of health condition studied
Early detection of breast cancer symptoms
ICD-10 code
C50.9
ICD-10 code description
Malignant neoplasm of breast

Primary outcomes

1

Description
Change the behavior as a result of training
Timepoint
Immediately and then two months
Method of measurement
questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Prior to the intervention, a one-shot protection motivation questionnaire is taken from individuals in the early detection of breast cancer. Educational intervention is carried out in 6 sessions and then the questionnaire will be filled in immediately and in two months.
Category
Behavior

2

Description
Control group:the questionnaire is filled in three times and additional educational work is not done.
Category
Behavior

Recruitment centers

1

Recruitment center
Name of recruitment center
Community Health Center
Full name of responsible person
Leila Hakimi
Street address
Dastgeyb Ave
City
Kalkhal
Province
Ardabil
Postal code
5681856151
Phone
+98 45 3242 1542
Email
HAKIMILEILA63@GMAIL.COM

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Camelia Rohani
Street address
Velenjak St. , Shahid Chamran Highway
City
Tehran
Province
Tehran
Postal code
1985717443
Email
Intl_office@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti 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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Leila Hakimi
Position
Masters Degree in Nursing
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Madani Ave
City
Kalkhal
Province
Ardabil
Postal code
5681856151
Phone
+98 452220884
Email
leila_hakimi@sbmu.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Leila Hakimi
Position
Masters Degree in Nursing
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Madani Ave
City
Kalkhal
Province
Ardabil
Postal code
5681856151
Phone
+45 242844
Email
LEILA_HAKIMI@sbmu.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Camelia Rohani
Position
Assistant Professor, Department of Community Health Nursing
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Iran, Tehran Velenjak St. , Shahid Chamran Highway
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 8865 5388
Email
cameliarohani@yahoo.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
Further details will be provided after the completion of the study
When the data will become available and for how long
One month after the completion of the study
To whom data/document is available
Academic Institutions
Under which criteria data/document could be used
I have no condition
From where data/document is obtainable
Shahid Beheshti university of Medical Sciences
What processes are involved for a request to access data/document
The study objectives have a relative overlap
Comments
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