Protocol summary

Summary
The purpose of this study is implementation and evaluation of educational interventions to improve preventive behavior of breast cancer on women at risk in Tehran. The main criteria for inclusion is all women over 30 years without breast cancer, and the main exclusion criteria is all women over 30 years who has breast cancer. The population of current study is 260 women at risk of breast cancer in Tehran. Quasi random allocation technique will be used to divide the sample into experimental (n = 130) and control (n = 130) groups. At first, a meeting will conduct in order to explain the purpose of the study for both groups. Then, the questionnaire will be completed by all respondents and the data will be analyzed by SPSS software and based on the results of this analysis, the problems and weak points of participants regarding performing preventive behavior of breast cancer will be distinguished and based on these results a education program will be designed and implemented on the experimental group in 6 sessions. After implementing the educational program to improve preventive behavior of breast cancer through group discussion, lectures and pamphlet, the experimental group participants persuaded to comply with the preventive behavior of breast cancer and also reinforced to follow the instructions noted in the pamphlet regarding these behaviors. After 3 months the questionnaire, again were completed by both the experimental and control groups. Due to ethical issues, training will be conducted to control group after completion of the post test.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201305068742N2
Registration date: 2013-06-12, 1392/03/22
Registration timing: prospective

Last update:
Update count: 0
Registration date
2013-06-12, 1392/03/22
Registrant information
Name
Fereshteh Majlessi
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8898 9134
Email address
majlesif@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2013-06-20, 1392/03/30
Expected recruitment end date
2013-12-21, 1392/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
ٍEvaluation of the effectiveness of the educational intervention on promotion of preventive behavior of breast cancer on at risk women in Tehran
Public title
The Impact of education on preventive behavior of breast cancer
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: all women over age 30 who are not diagnosed with breast cancer; Not have a history of breast biopsy; To have the literacy to understand the questions in the questionnaire; No history of chronic disease; They are living in Tehran; Informed consent to participate in research. Exclusion criteria: - All women over 30 year that: Do not have literate to understand and fill questions in the questionnaire; Have a history of chronic diseases (diabetes, hypertension, etc.);Have a history of breast cancer; Have a history of mammography and ultrasound for breast cancer; No resident in Tehran
Age
From 30 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 260
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Triple blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Tehran University of Medical Sciences
Street address
Tehran University of Medical Sience,Poursina,Enghelab
City
Tehran
Postal code
-
Approval date
2012-07-17, 1391/04/27
Ethics committee reference number
81549

Health conditions studied

1

Description of health condition studied
preventive behavior of breast cancer
ICD-10 code
C50
ICD-10 code description
Malignant neoplasm of breast

Primary outcomes

1

Description
Promotion of preventive behavior of breast Cancer
Timepoint
Before intervention and 3 months after intervention
Method of measurement
Researcher made questionnaire

Secondary outcomes

1

Description
Awareness of breast cancer prevention
Timepoint
Before and three months after education
Method of measurement
Questionnaire

Intervention groups

1

Description
Intervention Groups: face to face interviews and training with emphasis on doing preventive behavior of breast cancer. Regarding to implementation of intervention group participate to the face to face education in 6 session Content of interventional program will be based on preventive behavior of breast cancer. We will use different instructional media in order to facilitate learning about it. 3 month after delivery we will fill out post tests.
Category
Behavior

2

Description
Control: face to face training for the moral issues will perform in 6 sessions content of interventional program will be based on doing preventive behavior of breast cancer, to the control group after intervention
Category
Behavior

Recruitment centers

1

Recruitment center
Name of recruitment center
Health - care Center of South
Full name of responsible person
Maryam khazaee
Street address
Departmant of Health Education and Promotion,School of Public Health,Tehran University of Medical Sience,Poursina,Enghelab
City
Tehran

2

Recruitment center
Name of recruitment center
Health - care Center of Rey
Full name of responsible person
Maryam khazaee
Street address
Departmant of Health Education and Promotion,School of Public Health,Tehran University of Medical Sience,Poursina,Enghelab
City
Rey city

3

Recruitment center
Name of recruitment center
Health - care Center of Eslamshahr
Full name of responsible person
Maryam khazaee
Street address
Departmant of Health Education and Promotion,School of Public Health,Tehran University of Medical Sience,Poursina,Enghelab
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Professor Akbar Fotouhi
Street address
Tehran University of Medical Sience,Poursina,Enghelab
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Maryam Khazaee Pool
Position
PhD student in health education
Other areas of specialty/work
Street address
Departmant of Health Education and Promotion,School of Public Health,Tehran University of Medical Sience, Poursina, Enghelab.
City
Tehran
Postal code
Phone
+98 21 8898 9134
Fax
Email
khazaie_m@yahoo.comm_khazaee@razi.tums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Maryam Khazaee pool
Position
PhD student in health education
Other areas of specialty/work
Street address
Departmant of Health Education and Promotion,School of Public Health,Tehran University of Medical Sience,Poursina,Enghelab.
City
Tehran
Postal code
Phone
+98 21 8898 9134
Fax
Email
khazaie_m@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Maryam Khazaee pool
Position
PhD student
Other areas of specialty/work
Street address
Departmant of Health Education and Promotion,School of Public Health,Tehran University of Medical Sience,Poursina,Enghelab
City
Postal code
Phone
+98 21 8898 9134
Fax
Email
khazaie_m@yahoo.com
Web page address

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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