Protocol summary

Study aim
The Effect of Theory-Based Education on promoting Colorectal Cancer Screening Behavior in People 69-50Years Old
Design
Randomized controlled trial with 2 parallel groups in 2 comprehensive urban health service centers, for 2 intervention and control groups by block randomization with a sample size of 80 people (40 people for each group)
Settings and conduct
This study is conducted in Aligoudarz, first the pre-test questionnaire is completed by the participants and after analyzing the information, the educational needs of the intervention group based on the health belief model are performed in person. 1 month and 3 months after the intervention, the questionnaires are completed again and the individual's information before and after the intervention is analyzed with SPSS software.Blinding is not done
Participants/Inclusion and exclusion criteria
Age 50 to 69 years Iranian nationality residence in Aligoudarz No history of colon cancer Literacy for reading and writing Physical ability Having mental health Having decision-making power Access to cyberspace
Intervention groups
In this interventional study, 80 people aged 50 to 69 years in two intervention and control groups are evaluated. Both groups receive routine training related to colon cancer, but in the intervention group, training is done in person based on the Health Belief Model and Needs Assessment. Awareness, health belief model constructs, behavior and behavioral intention will be compared in 2 groups before the intervention, 1 month and 3 months after the intervention.
Main outcome variables
awareness, sensitivity, severity, perceived benefits and barriers, practice guides, self-efficacy and behavioral intent and behavior regarding colorectal cancer screening behavior

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20220216054041N1
Registration date: 2022-07-19, 1401/04/28
Registration timing: retrospective

Last update: 2022-07-19, 1401/04/28
Update count: 0
Registration date
2022-07-19, 1401/04/28
Registrant information
Name
Ferdous Ghyasi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 66 4332 2212
Email address
ghyasiferdos21@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-05-22, 1401/03/01
Expected recruitment end date
2022-06-22, 1401/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Theory-Based Education on promoting Colorectal Cancer Screening Behavior in People 69-50Years Old
Public title
The Effect of Theory-Based Education on promoting Colorectal Cancer Screening Behavior in People 69-50Years Old
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Age 50 to 69 years Iranian nationality residence in Aligoudarz No history of colon cancer Literacy for reading and writing Physical ability Having mental health Having decision-making power Access to cyberspace
Exclusion criteria:
Reluctance to cooperate Distorted and incomplete questionnaire Failure to attend more than 20% of training classes Immigrating to another city
Age
From 50 years old to 69 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 80
Randomization (investigator's opinion)
Randomized
Randomization description
Block Random Method will be used to assign eligible people to two groups. The size of the blocks is 4 and 6. Randomization will be done individually. In the Block Method, due to the use of different combinations in each block, it is not possible to predict the randomization sequence, so the concealment process will also be observed. For the guaranteed encryption process, the randomization files are generated in Excel and will remain close to the epidemiologist's colleague, then the Epidemiologist will be contacted to allocate the eligible people to two groups, the sick person, and to position each person in the groups, will be decided according to the randomization sequence. The online program available on the Sealed Envelope website will be used to generate the block randomization sequence.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
In this study, in addition to the constructs of the health belief model, behavioral intent and screening behavior are also investigated

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Arak University of Medical Sciences
Street address
Shahid Shiroodi St,Alam al-Huda St
City
Arak
Province
Markazi
Postal code
3819693345
Approval date
2021-12-05, 1400/09/14
Ethics committee reference number
IR.ARAKMU.REC.1400.265

Health conditions studied

1

Description of health condition studied
Behavioral intention and behavior of colorectal cancer screening in people aged 50 to 69 years
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
awareness
Timepoint
Before intervention and 1 month after educational intervention
Method of measurement
questionnaire

2

Description
colorectal cancer screening behavior
Timepoint
Before intervention and 1 and 3 month after educational intervention
Method of measurement
questionnaire

Secondary outcomes

1

Description
sensitivity
Timepoint
Before intervention and 1 month after educational intervention
Method of measurement
questionnaire

2

Description
severity
Timepoint
Before intervention and 1 month after educational intervention
Method of measurement
questionnaire

3

Description
perceived benefits
Timepoint
Before intervention and 1 month after educational intervention
Method of measurement
questionnaire

4

Description
perceived barriers
Timepoint
Before intervention and 1 month after educational intervention
Method of measurement
questionnaire

5

Description
causes to action
Timepoint
Before intervention and 1 month after educational intervention
Method of measurement
questionnaire

6

Description
self-efficacy
Timepoint
Before intervention and 1 month after educational intervention
Method of measurement
questionnaire

7

Description
behavioral intent
Timepoint
Before intervention and 1 month after educational intervention
Method of measurement
questionnaire

Intervention groups

1

Description
In the intervention group, the educational intervention was based on the model of health belief and needs assessment, which was done before the training and using valid books and educational booklets and the latest instructions issued by the Ministry of Health and appropriate to the level of literacy of learners and based on adult education. Health belief model structures will be prepared, developed and implemented.
Category
Behavior

2

Description
Control group: The control group will receive routine training from health centers.
Category
Behavior

Recruitment centers

1

Recruitment center
Name of recruitment center
Health centers No3
Full name of responsible person
Dr.mahboobeh khorsandi
Street address
saheli Street
City
Aligoudarz
Province
Lorestan
Postal code
6861819341
Phone
+98 66 4332 1735
Fax
+98 66 4332 5598
Email
ghyasiferdos21@gmail.com

2

Recruitment center
Name of recruitment center
Health centers No3
Full name of responsible person
Dr.mahboobeh khorsandi
Street address
golzar street
City
Aligoudarz
Province
Lorestan
Postal code
6861819341
Phone
+98 66 4332 3236
Fax
+98 66 4332 5598
Email
ghyasiferdos21@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr.mahboobeh khorsandi
Street address
Shahid Shiroodi St,Alam al-Huda St
City
Arak
Province
Markazi
Postal code
3818146851
Phone
+98 86 3366 2024
Fax
+98 86 3368 6443
Email
ghyasiferdos21@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Arak 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
Arak University of Medical Sciences
Full name of responsible person
Dr.mahboobeh khorsandi
Position
Professor, School of Health, Arak University of Medical Sciences
Latest degree
Ph.D.
Other areas of specialty/work
Health Promotion
Street address
Shahid Shiroodi St,Alam al-Huda St
City
Arak
Province
Markazi
Postal code
3819693345
Phone
+98 86 3313 6055
Email
khorsandi.mahboobeh@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr.mahboobeh khorsandi
Position
Professor, School of Health, Arak University of Medical Sciences
Latest degree
Ph.D.
Other areas of specialty/work
Health Promotion
Street address
Shahid Shiroodi St,Alam al-Huda St
City
Arak
Province
Markazi
Postal code
3819693345
Phone
+98 86 3313 6055
Email
khorsandi.mahboobeh@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Ferdous Ghyasi
Position
Masters student
Latest degree
Bachelor
Other areas of specialty/work
Health Promotion
Street address
Shahid Shiroodi St,Alam al-Huda St
City
Arak
Province
Markazi
Postal code
3819693345
Phone
+98 86 3313 6055
Email
ghasiferdos21@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
There is no more information
Study Protocol
No - There is not 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
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
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