The effectiveness of educational intervention base on Preventive Health Model for performing colorectal cancer screening in 30-50 years old population referred to health center of Karoon city in 2018
The Effectiveness of educational intervention base on Preventive Health Model for performing colorectal cancer screening in 30-50 years old population referred to health center of Karoon city in 2018
Design
Clinical trial with one intervention group and one control group, parallel groups and randomized.
Settings and conduct
The present study is a randomized controlled trial on two groups of test and control in 2018. The research population consists of 30-50 year old men and women referring to comprehensive health care centers of Karoun County. The data collection tool is a three-part questionnaire. Educational intervention involves installing the app and distributing pamphlets. Two months after completing the pre-test and intervention questionnaire, two groups will be contacted and invited to complete the questionnaire. After completing the questionnaires by both groups, the data will be entered into the SPSS 23 software and the data will be analyzed .
Participants/Inclusion and exclusion criteria
age 30 to 50,Inclination to participate in research, Diploma and higher education ,The absence of a person or primary relatives with colorectal cancer ,No history of colorectal screening ,People without any clinical symptoms, Having informed consent.
Non arrival:
Not having Android mobile phone to install educational content
Having physical limitation
Intervention groups
There will be no training and intervention for the control group. Educational content provided to the intervention group includes an app that is designed based on preventive health model, and an educational pamphlet on colorectal cancer, the importance of screening and a variety of colorectal cancer screening methods.
Main outcome variables
Perceived self-efficacy; Perceived sensitivity; Worries and fears; Screening efficiency; social support; Behavioral intention
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180909040980N1
Registration date:2019-02-04, 1397/11/15
Registration timing:registered_while_recruiting
Last update:2019-02-04, 1397/11/15
Update count:0
Registration date
2019-02-04, 1397/11/15
Registrant information
Name
Fatemeh Fayazi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 3553 1822
Email address
fatemeh.fayazi200@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-09-16, 1397/06/25
Expected recruitment end date
2019-03-16, 1397/12/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effectiveness of educational intervention base on Preventive Health Model for performing colorectal cancer screening in 30-50 years old population referred to health center of Karoon city in 2018
Public title
The effectiveness of educational intervention for performing colorectal cancer screening
Purpose
Screening
Inclusion/Exclusion criteria
Inclusion criteria:
Age 30 to 50 years
Inclination to participate in research
Diploma and higher education
The absence of a person or primary relatives with colorectal cancer
No history of colorectal screening
People without any clinical symptoms (asymptomatic)
Having informed consent
Exclusion criteria:
Not having Android mobile phone to install educational content
Having physical limitation
Age
From 30 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
160
Randomization (investigator's opinion)
Randomized
Randomization description
Samples were randomly selected from 2 centers by block sampling method and samples of both groups will be matched based on demographic variables such as age, education, and so on. Random assignment of selected individuals will be done by block random method using quad blocks. For two groups of
intervention and comparison use two letters A and B. So the size of each block is twice the number of groups, that is, the number 4. By dividing the sample
size by block size, the number of blocks is determined. Sample size is 160 people. Each group consists of 80 people, and the number of blocks in each group is 20 blocks, each of which specifies the assignment of 4 individuals. Finally, all letters A and B are separated, and each person who is not the researcher, by lot, will be suspended by each letter in a group. For example, A intervention group and B control group.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Committee of University of Medical Sciences of Jundishapur of Ahwaz
Street address
Ahvaz.Golestan.after Golestan Hospital, Jundishapur University of Ahvaz
City
Ahvaz
Province
Khouzestan
Postal code
15794- 61357
Approval date
2018-04-18, 1397/01/29
Ethics committee reference number
IR.AJUMS.REC.1397.319
Health conditions studied
1
Description of health condition studied
Colorectal cancer
ICD-10 code
C19
ICD-10 code description
Malignant neoplasm of rectosigmoid junction
Primary outcomes
1
Description
Perceived self-efficacy
Timepoint
2 months after the beginning of the study
Method of measurement
Colorectal screening questionnaire
2
Description
Perceived sensitivity
Timepoint
2 months after the beginning of the study
Method of measurement
Colorectal screening questionnaire
3
Description
Worries and fears
Timepoint
2 months after the beginning of the study
Method of measurement
Colorectal screening questionnaire
4
Description
Screening Effectiveness
Timepoint
2 months after the beginning of the study
Method of measurement
Colorectal screening questionnaire
5
Description
Social support
Timepoint
2 months after the beginning of the study
Method of measurement
Colorectal screening questionnaire
6
Description
Behavioral intention
Timepoint
2 months after the beginning of the study
Method of measurement
Colorectal screening questionnaire
Secondary outcomes
1
Description
Screening behavior
Timepoint
2 months after the beginning of the study
Method of measurement
Colorectal screening questionnaire
Intervention groups
1
Description
One group in the study will receive educational intervention. Educational content provided to the intervention group includes an app that is designed based on preventive health model, and an educational pamphlet about colorectal cancer, the importance of screening and a variety of colorectal cancer screening methods.
Category
N/A
2
Description
Control group: One group as a control group will enter the study, that will not receive any training and intervention.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Health center of Karoon City
Full name of responsible person
Fatemeh Fayazi
Street address
No9. Baharan 5 Ave, Padad Shahr, Ahvaz
City
Ahvaz
Province
Khouzestan
Postal code
6184911774
Phone
+98 61 3553 1822
Email
fatemeh.fayazi200@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Deputy of Research and Technology Developme nt of Jondishapour of Ahwaz
Street address
Jundishapur University of Medical Sciences and Health Services, Academic town, Golestan, Ahvaz
City
Ahvaz
Province
Khouzestan
Postal code
6125715794
Phone
+98 61 3333 3477
Fax
+98 61 3336 1544
Email
research@ajums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz 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
Ahvaz University of Medical Sciences
Full name of responsible person
Fatemeh Fayazi
Position
Employee
Latest degree
Bachelor
Other areas of specialty/work
Health Promotion
Street address
No9. Baharan 5 Ave, Padad Shahr, Ahvaz
City
Ahvaz
Province
Khouzestan
Postal code
6184911774
Phone
+98 61 3553 1822
Email
fatemeh.fayazi200@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Fatemeh Fayazi
Position
Master
Latest degree
Bachelor
Other areas of specialty/work
Health Promotion
Street address
Jundishapur University of Medical Sciences and Health Services, Academic town, Golestan, Ahvaz
City
Ahvaz
Province
Khouzestan
Postal code
6184911774
Phone
+98 61 3553 1822
Fax
Email
fatemeh.fayazi200@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Fatemeh Fayazi
Position
Master
Latest degree
Bachelor
Other areas of specialty/work
Health Promotion
Street address
Jundishapur University of Medical Sciences and Health Services, Academic town, Golestan, Ahvaz
City
Ahvaz
Province
Khouzestan
Postal code
6184911774
Phone
+98 61 3553 1822
Fax
Email
fatemeh.fayazi200@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD