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Effectiveness of an educational intervention based on fear appeals on attitude, behavioral intention and breast cancer preventive behaviors

Protocol summary

Summary
objectives: The aim of this study is to evaluate the attitude, behavioral intention and preventive behavior of breast cancer in women. This study is a population based study, and Inclusion criteria: women 40 years and older who do not have breast cancer and history , their first-degree relatives do not have this disease, have ability to read and write and have not psychological disorders will be in study. If there will not be even one of these criteria,the participant will reject . Study design:about 600 people will be sampled (according to the number of 40 years old and older women in Tehran and the time and financial limits), this number will be selected. Of course, we will try to maintain the characteristics of this type of study. This study is a cluster randomized control .Tehran is divided to 22 districts.Every districts in this study will subdivided to some blocks which are related to population so large districts will have more blocks. To avoid information contamination in study, blocks will be used separately for intervention and control . Blocks will randomly allocate to intervention and control and number of them are the same in every district.This study is not blinded . Some skilled female questioners will be educated and they visit women in their home in selected places. people will consent and give phone number for follow-up then will complete the researcher-made questionnaire (prepared on the basis of studies and its validity and reliability is done, and is approved by specialist ) .Implementation: the intervention group will receive (the 2 pamphlets which are designed and tested on the basis of fear appeals) at baseline and after 2 weeks. They are different in messages and photographs but in the same content. After 3 months follow up will be done, both the intervention and control group will complete the questionnaire again, control group will receive the two pamphlets used in the study to observe the ethics . The control group will receive nothing as educational material in this study. The main variables in this study are attitude,behavioral intention and preventive behaviors of breast cancer.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2017013032315N1
Registration date: 2017-09-14, 1396/06/23
Registration timing: prospective

Last update:
Update count: 0
Registration date
2017-09-14, 1396/06/23
Registrant information
Name
Vahideh Termeh zonouzy
Name of organization / entity
ّFaculty of Medical Sciences, Tarbiat Modares University
Country
Iran (Islamic Republic of)
Phone
+98 21 8288 3421
Email address
v.termeh@modares.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research,Tarbiat Modares University.
Expected recruitment start date
2017-10-01, 1396/07/09
Expected recruitment end date
2017-12-29, 1396/10/08
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effectiveness of an educational intervention based on fear appeals on attitude, behavioral intention and breast cancer preventive behaviors
Public title
fear appeal effect on attitude,behavioral intention and breast cancer preventive behaviors in women
Purpose
Prevention
Inclusion/Exclusion criteria
]Inclusion Criteria:40 years old and above ؛Have ability to read and write ؛Not have breast cancer and it's history؛ Not have breast cancer in her relative( mother,sister,daughter) and not have psychiatric disorders. Exclusion Criteria: If there will not even one inclusion criteria( like younger than 40), the participant will remove from study.
Age
From 40 years old to 99 years old
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 600
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Randomization in selecting blocks to intervention or control will be done with Excel software.

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee in Faculty of Medical Sciences, Tarbiat Modares University
Street address
pole nasr, Jalal al ahmad, Faculty of Medical Sciences, Tarbiat Modares University
City
Tehran
Postal code
Approval date
2015-11-09, 1394/08/18
Ethics committee reference number
IR.TMU.REC.1394.150

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
Attitude
Timepoint
Before and3 months after manipulation
Method of measurement
Using questionnair is made by researcher for this study

2

Description
Behavioral intention
Timepoint
Before and3 months after manipulation
Method of measurement
Using questionnair is made by researcher for this study

3

Description
Behavior
Timepoint
Before and3 months after manipulation
Method of measurement
Using questionnair is made by researcher for this study

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: using 2 designed pamphlets based on fear appeals. people receive the first one after completing the questionnaire at baseline and, after 2 weeks.
Category
Prevention

2

Description
Control group: There is no implementation in control group in this study.
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
samples will be collected in Tehran( in all 22 districts ).
Full name of responsible person
Dr. Shamsedin Niknami
Street address
Pole Nasr, Jalal Al Ahmad, Faculty of Medical Sciences, Tarbiat Modares University, Tehran, Iran
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research,Tarbiat Modares University
Full name of responsible person
Dr.Shamsedin Niknami
Street address
Pole Nasr, Jalal Al Ahmad, Tehran, Iran
City
Tehran
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,Tarbiat Modares University
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
Facultyl of Medical Siences, Tarbiat Modares University
Full name of responsible person
Dr.Shamsedin Niknami
Position
Faculty Member
Other areas of specialty/work
Street address
pole Nasr, Jalal Al Ahma, Tehran, Iran
City
Tehran
Postal code
Phone
+98 21 8288 3845
Fax
Email
Niknamis@modares.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Health Siences Research Institute, Jahad Daneshgahi
Full name of responsible person
Dr. Ali Montazeri
Position
Head of institute - phd
Other areas of specialty/work
Street address
No 23, Vahide Nazari Street, Felestin Avenue, Tehran, Iran
City
Teharan
Postal code
Phone
+98 21 6695 1877
Fax
Email
montazeri@acecr.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Faculty of Medical Sciences, Tarbiat Modares University
Full name of responsible person
Vahideh Termeh Zonouzy
Position
phd student
Other areas of specialty/work
Street address
Pole Nasr, Jalal Al Ahmad,Tehran, Iran
City
Tehran
Postal code
Phone
Fax
Email
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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