To evaluate the effect of educational program based on Health Belief Model on adopting preventive behaviors of breast cancer in women of reproductive age referring to Qazvin comprehensive health centers.
Design
Clinical trial with control and intervention groups, parallel, blinded, simple randomized groups
Settings and conduct
The study population consisted of women of reproductive age of 18-49 years who were covered by health centers in Qazvin. Samples were entered in a list from lowest to highest score based on the Health Literacy Assessment Tool and then randomly selected 84 individuals (depending on the number of sample size in phase II). The infestation of information is first taken by the control group and entered into the study after the intervention group.
Participants/Inclusion and exclusion criteria
Arrival: literate women of reproductive age (18-49 years)
Women residing in Qazvin city
Having active file in health community centers.
Exclusion: Any Factor That Impairs Women's Participation: Immigration
Breast cancer
Having mental and physical illnesses
Intervention groups
Intervention group In addition to the current training of the center, they receive educational intervention based on Health Belief Model. The control group received only the current training of the center.
Main outcome variables
Health belief model constructs (Awareness, Perceived severity, Perceived benefits, Perceived barriers, Self-efficacy, Cue for action).
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200201046323N1
Registration date:2020-02-08, 1398/11/19
Registration timing:prospective
Last update:2020-02-08, 1398/11/19
Update count:0
Registration date
2020-02-08, 1398/11/19
Registrant information
Name
Sara Chalambari
Name of organization / entity
Tarbiyat Modares Univercity
Country
Iran (Islamic Republic of)
Phone
+98 21 6522 7097
Email address
s.chalambari@modares.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-02-19, 1398/11/30
Expected recruitment end date
2020-06-18, 1399/03/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Educational Intervention Based on Health Belief Model in Breast Cancer Prevention Behaviors in Women of Reproductive Age
Public title
The effect of education on preventive behaviors of breast cancer
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Literate women
Women residing in Qazvin city
Women with active profile in community health centers
Women of reproductive age (18-49 years)
Exclusion criteria:
Migration and emigration
Experience of Breast Cancer
Physical and neurological diseases Suffering
Illiteracy
Age
From 18 years old to 49 years old
Gender
Female
Phase
1
Groups that have been masked
No information
Sample size
Target sample size:
84
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization gives each woman an equal chance of being selected. In this way, the names of eligible women will be listed and numbered. They are then selected at random. According to the law of probability, the people selected must have the same characteristics as the community from which they are elected.
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 Tarbiat Modares University
Street address
Tehran Jalal AleAhmad Nasr P.O.Box: 14115-111
City
Tehran
Province
Tehran
Postal code
1411713116
Approval date
2020-01-14, 1398/10/24
Ethics committee reference number
IR.MODARES.REC.1398.203
Health conditions studied
1
Description of health condition studied
Brest Cancer Preventive Behaviour
ICD-10 code
C50.9
ICD-10 code description
Malignant neoplasm of breast
Primary outcomes
1
Description
Preventive Behaviors of Breast Cancer
Timepoint
Measurement of behavior before, immediately after intervention, 3 months after educational intervention
Method of measurement
Using a Man-made questionnaire "Effectiveness of Health Education Based on Health Belief Model in Adoption of Preventive Behaviors of Breast Cancer", which was psychometric evaluated by Kalan-FermanFarma et al.in 2014.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Women are eligible to receive 10 training sessions (lectures, group discussions) in addition to the routine training provided by the Comprehensive Health Centers. In addition to completing the pre-test questionnaire, the group will complete a questionnaire assessing the effectiveness of educational intervention on preventive behaviors immediately after and three months after the intervention.
Category
Behavior
2
Description
Control group: Women are eligible to receive no educational intervention program other than routine training provided by comprehensive health centers. In addition to completing the pre-intervention questionnaire, the group will complete a questionnaire assessing the effectiveness of educational intervention on preventive behaviors immediately after and three months after the intervention.
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Bolandian Health Center
Full name of responsible person
Sara Chalambari
Street address
End of Shahid Babaei Street ,Next to the Canal
City
Qazvin
Province
Qazvin
Postal code
3414763111
Phone
+98 28 3365 2972
Email
sara74chalambari@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Faculty of Medical Sciences, Tarbiat Modares University
Full name of responsible person
Dr. Jacob Fathollahi
Street address
Tehran, Jalal Al Ahmad, Nasr, Tarbiat Modarres University
City
Tehran
Province
Tehran
Postal code
141173116
Phone
+98 21 8288 4506
Email
Aminsh_f@modares.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Faculty of Medical Sciences, Tarbiat Modares University
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
Faculty of Medical Sciences, Tarbiat Modares University
Full name of responsible person
Ferdinand Amin Shokravi
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Health Promotion
Street address
Tehran-Jalal Al Ahmad, Nasr, Tarbiat Modarres University
City
Tehran
Province
Tehran
Postal code
1411713116
Phone
+98 21 8288 4506
Email
Aminsh_f@modares.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Faculty of Medical Sciences, Tarbiat Modares University
Full name of responsible person
Ferdinand Amin Shokravi
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Health Promotion
Street address
Tehran-Jalal Al Ahmad, Nasr, Tarbiat Modarres University
City
Tehran
Province
Tehran
Postal code
1411713116
Phone
+98 21 8288 4506
Email
Aminsh_f@modares.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Faculty of Medical Sciences, Tarbiat Modares University
Full name of responsible person
Ferdinand Amin Shokravi
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Health Promotion
Street address
Tehran-Jalal Al Ahmad, Nasr, Tarbiat Modarres University
City
Tehran
Province
Tehran
Postal code
1411731116
Phone
+98 21 8288 4506
Email
Aminsh_f@modares.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is 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
Yes - There is a plan to make this available
Title and more details about the data/document
Demographic information is confidential but information about the consequences of awareness, perceived severity, perceived benefits, perceived barriers, self-efficacy, cues to action , and shareable practice
When the data will become available and for how long
One week after receiving the request by email to the principal of the study
To whom data/document is available
Researchers at the scientific and academic institutes of the Ministry of Health
Under which criteria data/document could be used
Vice Chancellors for Health, Universities of Medical Sciences
From where data/document is obtainable
With Dr. Farkhondeh Amin Shokravi in charge of the study by email: Aminsh_f@modares.ac.ir
What processes are involved for a request to access data/document
one week after receiving an email by corresponding researcher