Determine the effect of the theory-based educational intervention on women's health beliefs about breast cancer screening behavior
Design
In this Randomized clinical trial (RCT) study 100 eligible women will be selected from qualified women referring to health centers. Then, 50 women in the control group and 50 in the intervention group will be randomly assigned.For random assignment of samples, in each center, samples will select cards A and B. People with card A in the intervention group and the B card will be in the control group.
Settings and conduct
Among the comprehensive health centers of Khoy, three centers will be selected from 3 regions of the city with low socioeconomic status, medium and high. The researcher selects 33 women from each center with convenience sampling. After explaining the goals of the study, women who are eligible to enter the study and gaining confidence in their willingness to participate in the research, the questionnaire prepared by them will be completed. Then, 50 people will be randomly assigned to the control group and 50 will be in the intervention group. After performing educational intervention in the intervention group, the questionnaires will be filled in by both groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Inclination to participate in the study, age over 20 years old,
having literacy
Exclusion criteria:having breast cancer, getting instructional materials on breast cancer and its screening behaviors
Intervention groups
Educational intervention based on health belief model to promote women's beliefs about breast cancer screening behaviors that will be performed in the intervention group in 4 sessions and the control group will not receive any intervention.
Main outcome variables
Women's Health Beliefs on Breast Cancer Screening Behaviors
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20160203026347N9
Registration date:2018-12-29, 1397/10/08
Registration timing:registered_while_recruiting
Last update:2018-12-29, 1397/10/08
Update count:0
Registration date
2018-12-29, 1397/10/08
Registrant information
Name
Soheyla Ahangarzade Rezaei
Name of organization / entity
Urmia University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 44 3223 4897
Email address
rezaei.s@umsu.ac.ir
Recruitment status
Recruitment complete
Funding source
Urmia University of Medical Sciences
Expected recruitment start date
2018-03-21, 1397/01/01
Expected recruitment end date
2019-03-20, 1397/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of theory based educational program on femailes' health beliefs toward breast cancer screening behaviors.
Public title
The effect of theory based educational program on femailes' health beliefs toward breast cancer screening behaviors.
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
The desire to participate in the study
20 years old
Having literacy
Exclusion criteria:
Women with breast cancer
Getting educational materials about breast cancer and screening behaviors
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
In each center, in terms of the number of people selected, cards A and B are written to select by samples. People with card A in the intervention group and the B card will be in the control group
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 Urmia University of Medical Sciences
Street address
Urmia university of Medical Sciences, Orghans Alley, Resalat Boulevard
City
Urmia
Province
West Azarbaijan
Postal code
5714783734
Approval date
2017-06-04, 1396/03/14
Ethics committee reference number
IR.UMSU.REC.1396.128
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
health beliefs
Timepoint
Before intervention, 2 weeks after the last training session
Method of measurement
Champion Health Belief Model Scale
Secondary outcomes
1
Description
Health beliefs about breast cancer screening behaviors
Timepoint
Before intervention, 2 weeks after the last training session
Method of measurement
Champion Health Belief Model Scale
Intervention groups
1
Description
Intervention group: The intervention in the intervention group will be held in four sessions of 90 minutes. For educational intervention, combined methods including direct and indirect training methods will be used. Considering the goal of the study, which is to change the health beliefs of women, the use of speech lecture alone will not be effective, but also interactive methods should be used including group discussion and question and answer.
Category
Prevention
2
Description
Control group: In the control group, no intervention will be performed.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Comprehensive Health Services Center No. 6
Full name of responsible person
Zahra Shaabanloei
Street address
Comprehensive Health Services Center No. 6, opposite Mellat Bank, Modarres Blvd
City
Khoy
Province
West Azarbaijan
Postal code
5816646852
Phone
+98 44 3633 2253
Email
l.mokhtary@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Dr Iraj Mohebi
Street address
Urmia University of Medical Science (UMSU), UMSU Central Site: Orjhans Street, Resalat Blvd, Urmia , Iran
City
Urmia
Province
West Azarbaijan
Postal code
571478334
Phone
+98 44 3223 4897
Fax
+98 44 3222 9059
Email
college@umsu.ac.ir
Web page address
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Oroumia 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
Oroumia University of Medical Sciences
Full name of responsible person
Dr Soheila Ahangarzade Rezaei
Position
Assistent professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Pardis Nazlou, 11 km of Nazlou Road, Faculty of nursing & midwifery, Urmia, Iran
City
Urmia
Province
West Azarbaijan
Postal code
5756115111
Phone
+98 44 3275 4961
Fax
+98 44 3222 9059
Email
rezaei.s@umsu.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Dr Soheila Ahangarzade Rezaei
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Faculty of nursing & Midwifery, Pardis Nazlou, 11 km of Nazlou Road, Urmia, Iran
City
Urmia
Province
West Azarbaijan
Postal code
5756115111
Phone
+98 44 3275 4961
Fax
Email
rezaei.s@umsu.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Leila Mokhtari
Position
iNSTRUCTOR
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Faculty of nursing & Midwifery, Pardis Nazlou, 11 km of Nazlou Road, Urmia, Iran
City
URMIA
Province
West Azarbaijan
Postal code
5756115111
Phone
+98 44 3275 4961
Fax
Email
l.mokhtary@gmail.com
Web page address
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
Undecided - It is not yet known if there will be 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
No - There is not a plan to make this available
Clinical Study Report
Not applicable
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available