1. Home
  2. Approved trials
  3. » فارسی

The role of breast cancer risk assessment in educational intervention based on Health Belief Model for mammography performance in women with family history of breast cancer

Protocol summary

Study aim
Determining the role of breast cancer risk assessment in educational intervention based on health belief model on mammography in women with a family history of breast cancer
Design
A randomized controlled clinical trial with 3 groups with parallel groups of 210 women aged 40 years and older living in Bushehr. Three groups will be assigned
Settings and conduct
In women living in Bushehr, after sampling and contacting people to attend the center and after completing the questionnaires, in the group of educational intervention with a model of health belief and risk assessment, first using the online breast cancer risk assessment program based on the model IBIS risk evaluator Edition 10's lifetime risk is estimated and the results are interpreted for the person, then the delivery of a booklet based on the structures of the health belief model, the person is asked to do within the next 3 months Have a mammogram and repeat it annually
Participants/Inclusion and exclusion criteria
Admission of women 40 years and older with a family history of breast cancer and no mammography during the past two years, literacy, lack of urination and breastfeeding, willingness to participate in the study of no breast cancer or other cancers and living in Bushehr At the time of conducting the study and leaving the study, not reading the educational booklet at the specified time and carrying the sample
Intervention groups
1- Educational intervention group with health belief model and risk assessment, 2- Risk assessment group 3- Control group
Main outcome variables
Perceived sensitivity, perceived severity, perceived benefits, perceived barriers, health motivation, risk of breast cancer, mammography

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20200721048161N1
Registration date: 2020-08-02, 1399/05/12
Registration timing: prospective

Last update: 2020-08-02, 1399/05/12
Update count: 0
Registration date
2020-08-02, 1399/05/12
Registrant information
Name
Hajar Tamimi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 77 3483 2188
Email address
tamimi.h.65@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-09-21, 1399/06/31
Expected recruitment end date
2020-11-20, 1399/08/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The role of breast cancer risk assessment in educational intervention based on Health Belief Model for mammography performance in women with family history of breast cancer
Public title
The role of breast cancer risk assessment in educational intervention based on Health Belief Model for mammography performance in women with family history of breast cancer
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Women 40 years and older Having a family history of breast cancer Not having a mammogram for the past two years Literacy for reading and writing Lack of urination and breastfeeding Willingness to participate in the study No person has breast cancer or other cancers Living in Bushehr at the time of the study
Exclusion criteria:
Failure to read the training booklet at the time specified for the participants Getting pregnant during the study
Age
From 40 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 210
Randomization (investigator's opinion)
Randomized
Randomization description
After preparing the selected samples, individuals will be randomly assigned to three groups (random allocation) to In this way, the names of the people are written on separate sheets and by lottery, the first choice will be assigned to the educational intervention group with the pattern of health belief and risk assessment, the second to the risk assessment group and the third to the control group. It will continue for other people to assign people in groups.
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 Bushehr University of Medical Sciences
Street address
Salman Farsi St. Bushehr University of Medical Sciences
City
Bushehr
Province
Boushehr
Postal code
7514633341
Approval date
2020-07-18, 1399/04/28
Ethics committee reference number
IR.BPUMS.REC.1399.065

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
Doing and not doing mammography
Timepoint
Before training and three months after training
Method of measurement
View mammography answers

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group:In the group of educational intervention with the model of health belief and risk assessment, first using the online program of breast cancer risk assessment based on Gil model edited by IBIS risk evaluator, the 10-year and lifetime risk of the person is estimated and the results are interpreted for the person. Which were based on the structures of the health belief model received.
Category
Prevention

2

Description
Intervention group: In individuals in the risk assessment group, using the online breast cancer risk assessment program based on the Gil model edited by IBIS risk evaluator, the 10-year and lifetime risk is estimated and the results are compared based on the percentage of risk of cancer in the next 10 years. With similar people in terms of age and type of risk of cancer (low risk, moderate risk or high risk) based on what is specified in this online program
Category
Prevention

3

Description
Control group: The control group did not receive any training until the end of the study period (after completing the second stage questionnaires).
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Cancer Registration Center
Full name of responsible person
Hakimeh Abadi
Street address
Sports Street in front of Mosalla Jomeh, Bushehr University of Medical Sciences
City
Bushehr
Province
Boushehr
Postal code
7514633341
Phone
+98 77 3333 0743
Email
hakimehabadi51@gmail.com
Web page address

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Boushehr University of Medical Sciences
Full name of responsible person
Gholamreza Khamisipour
Street address
Salman Farsi St. Bushehr University of Medical Sciences
City
Bushehr
Province
Boushehr
Postal code
7516433341
Phone
+98 77 2333 1802
Fax
+98 77 2333 1802
Email
khamisipoor@bpums.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
Boushehr 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
Boushehr University of Medical Sciences
Full name of responsible person
Dr. Azita Norouzi
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Health Promotion
Street address
Salman Farsi St. Bushehr University of Medical Sciences
City
Bushehr
Province
Boushehr
Postal code
7514633341
Phone
+98 917 772 4605
Email
azitanoroozi@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Boushehr University of Medical Sciences
Full name of responsible person
Dr. Azita Norouzi
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Health Promotion
Street address
Salman Farsi St. Bushehr University of Medical Sciences
City
Bushehr
Province
Boushehr
Postal code
7514633341
Phone
+98 917 772 4605
Email
azitanoroozi@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Boushehr University of Medical Sciences
Full name of responsible person
Hajar Tamimi
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Public Health
Street address
Shahid Jahandideh St. 75693-75671
City
Saadabad
Province
Boushehr
Postal code
7567175693
Phone
+98 917 770 2167
Email
tamimi.h.65@gmail.com

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
No - There is not 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
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Loading...