Protocol summary

Summary
The education effect base on health belief model on screening behaviors in high risk women The aim of this randomized controlled clinical trial is to investigation of breast screening behaviors in high risk women for breast cancer after appropriate educations as target group. 100 participant will be recruited who are high risk for breast cancer according to their family history of breast cancer in their first degree relative( mother, sister or daughter) , but they are not diagnosed for any kind of malignancy such as breast cancer and should be in a healthy condition in order to participate at educational sessions. They will be allocated in experiment and control group. People in experiment group will be educated for breast screening methods in 10-15 people in a class in the radiation ward of Shohada-e-Tajrish Hospital. Participants in control group will not be given any education like the experiment participants. Variables of the present study are: knowledge, perceived severity, perceived usefulness, perceived barriers , perceived susceptibility, self efficacy, breast screening behaviors rate.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201101015525N1
Registration date: 2011-06-20, 1390/03/30
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2011-06-20, 1390/03/30
Registrant information
Name
Sepidh Hajian
Name of organization / entity
Sharoud Mdical Science University
Country
Iran (Islamic Republic of)
Phone
+98 27 3339 5054
Email address
hajia@shmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Reproductive health reserch Center of Medical Science of Shahid Beheshti University
Expected recruitment start date
2010-01-10, 1388/10/20
Expected recruitment end date
2010-07-27, 1389/05/05
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The education effect base on health belief model on screening behaviors in high risk women
Public title
breast screening behaviors
Purpose
Prevention
Inclusion/Exclusion criteria
inclusion criteria: every woman who is at risk of breast cancer (because of family history of breast malignancy in her first degree relative i.e mother,sister, daughter) but has not been diagnosed for any kind of malignancy and /or suspicios pathologic of breast tumor can be rectuited for intervention if she has been not diagnosed for breast cancer . Meanwhile having general well being and health to attending at indtructive sessions . exclusion criteria: every woman with any kind of malignancy , unabling ti attending at instuctive sessions due to illness, dwelling out of Tehran
Age
No age limit
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)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Reproductive health Research Center of Shahid Beheshti Medical Sciecnce University
Street address
3th floor,Ayatollah Taleghani Hospital,Parvaneh,st.Yaman st.Velenjak,Avenue,Tehran,Iran
City
Tehran
Postal code
Approval date
2009-12-20, 1388/09/29
Ethics committee reference number
6114-3141

Health conditions studied

1

Description of health condition studied
breast screening brehaviours
ICD-10 code
c50
ICD-10 code description
c50

Primary outcomes

1

Description
breast self examination
Timepoint
before and 3 months after intervention
Method of measurement
chech list and questionnaire

2

Description
clinical examination
Timepoint
before and 3 months after intervention
Method of measurement
check list and questionnaire

3

Description
mamography
Timepoint
before and 3 months after intervention
Method of measurement
chech list and questionnaire

Secondary outcomes

1

Description
knowledge
Timepoint
before and 3 months after intervention
Method of measurement
questionnaire

2

Description
perceived severity
Timepoint
before and 3 months after intervention
Method of measurement
questionnaire

3

Description
perceived benefits
Timepoint
before and 3 months after intervention
Method of measurement
questionnaire

4

Description
perceived barriers
Timepoint
before and 3 months after intervention
Method of measurement
questionnaire

5

Description
perceived sucseptibility
Timepoint
befoer and 3 months after intervention
Method of measurement
questionnaire

6

Description
self efficacy
Timepoint
before and 3 months after intervention
Method of measurement
questionnaire

Intervention groups

1

Description
In intervention group all educations will be given based on Health Belief Model in order to behaviour change.The sassions will be held in 10-15 people groups assisting lecture,slide, posters and film presentations and instructive pamphlets will be given to participants.
Category
Early detection

2

Description
In control group we do not give them the instructions in intervention group , however if they want will be guide to health care providers to be educated .Then they will be followed up 3 months later.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Shohada-e- Tajrish Hospital
Full name of responsible person
Hamid Reaza Mirzaei
Street address
Padiation ward-Shohada-e- Tajrish Hospital Tajrish sq.Tehran,Iran
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Reproductive HealthResearch Center of Shaid Beheshti Medical Science University
Full name of responsible person
Dr.Seyed Jalil Hoseini
Street address
3th floor,Reproductive HealthResearch Center,Ayatollah Taleghani Hospital Tehran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Reproductive HealthResearch Center of Shaid Beheshti Medical Science 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
Shohada Tajrish Hospital
Full name of responsible person
Hamid Reza Mirzaei
Position
assistant professor of radiation oncology
Other areas of specialty/work
Street address
Shohada Tajrish Hospital,Tajrish sq.Tehran
City
Tehran
Postal code
Phone
+98 21 2271 8081
Fax
Email
mirzaei65@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahroud Medical Science University
Full name of responsible person
Sepideh Hajian
Position
PhD student
Other areas of specialty/work
Street address
Shahroud Medical Science University,7th Tirsq.Shahroud
City
Shahroud
Postal code
Phone
+98 27 3339 5054
Fax
Email
hajia@shmu.ac.irhajian74@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Shahroud Medical Science University
Full name of responsible person
Sepideh Hajian
Position
PhD student
Other areas of specialty/work
Street address
Reproductive HealthDepartment,Medical Science University,7th Tir sq.Shahroud,Iran.
City
Shahroud
Postal code
Phone
+98 27 3339 5954
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
Loading...