Protocol summary

Summary
Objectives: Evaluation of Educational Program based on Integrated model health action process approach (HAPA) with Protection Motivation Theory (PMT) on breast cancer screening is:: Women over 40 years of age in health centers in Shahid Beheshti University of Tehran. Intervention group: (PARDIS Health Network). control group: (PARDIS Health Network) Sample size: The intervention group consisted of 40 individuals in the control group including 40 educational programs based on predictive structures Integrated model health action process approach (HAPA) with Protection Motivation Theory (PMT)in women 40 years old for 10 weeks .evaluation, and average score of structures before, after and 6 months after intervention. An intervention program with a group discussion class that will consider electronic learning facilities as part of the phase. Breast self-examination check list and initial questionnaire are used at intervals. There is no intervention in the control group.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2017061134472N1
Registration date: 2017-08-19, 1396/05/28
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2017-08-19, 1396/05/28
Registrant information
Name
Fatemeh Pourhaji
Name of organization / entity
Tarbiat Modares University
Country
Iran (Islamic Republic of)
Phone
+98 21 7742 8982
Email address
fatemeh.pourhaji@modares.ac.ir
Recruitment status
Recruitment complete
Funding source
Tarbiat Modares University
Expected recruitment start date
2017-07-23, 1396/05/01
Expected recruitment end date
2018-12-02, 1397/09/11
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of Educational Program based on Integrated model health action process approach (HAPA) with Protection Motivation Theory (PMT) on breast cancer screening Behavior in women older than 40 years old
Public title
Integrated model health action process approach (HAPA) with Protection Motivation Theory (PMT)
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: lack of breast cancer disease in themselves and first-degree family members; a written consent to participate in the study; the age of the person participating in the research must be over 40 years of age; individuals must have Iranian nationality. Exclusion criteria: if they have more than one-time attending classes, they will be excluded from the study; exposure to severe psychological stress during the past 6 months, including relatives' deaths or surgical procedures during the conduct of research.
Age
From 40 years old to 80 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 400
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
The intervention program is based on the predictive variables of the Integrated Health action Process Approach (HAPA) model with Protection Motivation Theory (PMT). The educational content includes breast cancer screening behavior. To determine the samples of the intervention and control groups for implementation of the educational program based on the integrated model of the Health Process Approach (HAPA) with the Protection Motivation Theory (PMT) from the 4 selected health centers, 2 health centers were randomly assigned to one of the two groups as an intervention and control group Taking place in one of the selected centers, interventions are carried out, and people in the center will be considered as witnesses. Participants are randomly selected in the study.

Secondary Ids

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Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Medical school in Tarbiat Modares University of Medical Sciences
Street address
1 room, on the first floor of Medical Ethics, Tarbiat modares University, Paul Geishaو, Tehran Tehran Tehran Iran, Islamic Republic Of
City
Tehran
Postal code
14115-111
Approval date
2016-05-03, 1395/02/14
Ethics committee reference number
IR.TMU.REC.1395.328

Health conditions studied

1

Description of health condition studied
Breast cancer screening
ICD-10 code
C50
ICD-10 code description
Malignant neoplasm of breast

Primary outcomes

1

Description
Determination and comparison of mean score of predictive structures of breast cancer screening behavior in intervention and control groups; Determination and comparison of mean scores of breast cancer screening behavior in intervention and control groups
Timepoint
Before, after and 6 months after intervention
Method of measurement
Questioner

Secondary outcomes

1

Description
Determine and compare the rate of breast cancer screening behavior in the intervention and control group
Timepoint
Before, after and 6 months after intervention
Method of measurement
Questionar

Intervention groups

1

Description
Intervention group: Conducting an educational program to enhance the structure of the integrated model of the health action process approach with the protection motivation theory in 4 sessions of 2 hours Follow up of the intervention group by 10 weekly reminders by texting and assigning assignments. Also, the film and poster of breast cancer screening behavior Will be sent through the compact disc.
Category
N/A

2

Description
Control group: did not receive any training on breast cancer screening behavior. Follow up of this group only to complete questionnaires at specified intervals
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahid Beheshti University of Medical Sciences of Iran
Full name of responsible person
Fatemeh Pourhaji
Street address
Units7, 4, 126, Molavi street, Etellaat Square, Tehranno, Tehran.
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research,Tarbiat Modares University
Full name of responsible person
Dr. Ya'qub Fath Allahi Nane Karan
Street address
Third floor, Central Building 1,Tarbiat Modares University
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
Tarbiat modares University
Full name of responsible person
Fatemeh Pourhaji
Position
PhD candidate of Health education and health promotion
Other areas of specialty/work
Street address
Room 111, 2nd, Faculty of Medicine 1, Paul Gisha, Tehran
City
Tehran
Postal code
1743874918
Phone
+98 21 7742 8982
Fax
Email
fatemeh.pourhaji@modares.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tarbiat Modares University
Full name of responsible person
Dr. Fazlollah Ghofranipour
Position
Professor
Other areas of specialty/work
Street address
Room 121, 2nd, Faculty of Medicine 1, Tarbiat Modares University, Gisha Bridge, Tehran.
City
Tehran
Postal code
14115-111
Phone
+98 21 8288 3869
Fax
Email
ghofranf@modares.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Tarbiat modares University
Full name of responsible person
Fatemeh Pourhaji
Position
PhD candidate of Health education and health promotion
Other areas of specialty/work
Street address
Room 111, 2nd, Faculty of Medicine 1, Paul Gisha, Tehran.
City
Tehran
Postal code
1743874918
Phone
+98 21 7742 8982
Fax
+98 21 2224 7383
Email
fatemeh.pourhaji@modares.ac.irpourhaje.1364@gmail.com
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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