Protocol summary

Summary
This research is interventional study of experimental type that will be carried out with the purpose the design, implementation and evaluation of an educational intervention to increase colorectal cancer screening by using the intervention mapping approach in adults Hamadan city. Methods: After preliminary studies, 244 subjects over 40 years referred to health care centers in Hamadan using multi-stage sampling in 4 group will be placed. the intervention group 1 (intervention included holding educational sessions, distribution of educational aids tools such as pamphlet, film and free access to fecal occult blood test); the intervention group 2 (intervention included holding educational sessions, distribution of educational aids tools such as pamphlet, film); the intervention group 3 (free access to fecal occult blood test) and control group (receiving usual care). Inclusion criteria: Residing in Hamadan; In the age group over 40 years; Lack of screening (fecal occult blood test and colonoscopy) and Exclusion criteria: Failure to cooperate with researchers; moved to another city during the study period. before and 4 months after intervention data on demographics, knowledge, colorectal and Preventive health model structures will collect by questionnaire and practice will be measured by using fecal occult blood test (FOBT).

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2015041821822N1
Registration date: 2015-06-28, 1394/04/07
Registration timing: prospective

Last update:
Update count: 0
Registration date
2015-06-28, 1394/04/07
Registrant information
Name
Fereshteh Besharati
Name of organization / entity
Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 3838 0292
Email address
f.besharati@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Hamadan University of Medical Sciences
Expected recruitment start date
2015-09-06, 1394/06/15
Expected recruitment end date
2016-09-20, 1395/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Design, implementation and evaluation of an educational intervention to increase colorectal cancer screening: An application of intervention mapping approach
Public title
Intervention program to increase colorectal cancer screening
Purpose
Screening
Inclusion/Exclusion criteria
Inclusion criteria: Residing in Hamadan; In the age group over 40 years; Lack of screening (fecal occult blood test and colonoscopy) and Exclusion criteria: Failure to cooperate with researchers; moved to another city during the study period
Age
From 40 years old to 75 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 244
Randomization (investigator's opinion)
Randomized
Randomization description
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 Hamadan University of Medical Sciences
Street address
Hamadan University of Medical Sciences, Shahid Fahmideh Av,Hamadan,Iran
City
Hamadan
Postal code
6517838678
Approval date
2015-02-28, 1393/12/09
Ethics committee reference number
p/16/35/9/6385

Health conditions studied

1

Description of health condition studied
Colorectal cancer
ICD-10 code
c-18, c-19
ICD-10 code description
Malignant neoplasm of colon and rectum

Primary outcomes

1

Description
Perceived severity
Timepoint
Before and 4 months after intervention
Method of measurement
Questionnaire

2

Description
Knowledge
Timepoint
Before and 4 months after intervention
Method of measurement
Questionnaire

3

Description
Perceived susceptibility
Timepoint
Before and 4 months after intervention
Method of measurement
Questionnaire

4

Description
Intention
Timepoint
Before and 4 months after intervention
Method of measurement
Questionnaire

5

Description
Perceived barriers
Timepoint
Before and 4 months after intervention
Method of measurement
Questionnaire

6

Description
Social support
Timepoint
Before and 4 months after intervention
Method of measurement
Questionnaire

7

Description
Self efficacy
Timepoint
Before and 4 months after intervention
Method of measurement
Questionnaire

8

Description
Perceived benefits
Timepoint
Before and 4 months after intervention
Method of measurement
Questionnaire

Secondary outcomes

1

Description
FOBT
Timepoint
After intervention
Method of measurement
Stool Test

Intervention groups

1

Description
Intervention group1: Interventions included holding educational sessions, distribution of educational aids tools such as pamphlet, film and free access to fecal occult blood test
Category
Prevention

2

Description
Intervention group2: Interventions included holding educational sessions, distribution of educational aids tools such as pamphlet and film
Category
Prevention

3

Description
Intervention group3: free access to fecal occult blood test
Category
Prevention

4

Description
Control group: For the control group will not perform any of the action that will be taken for the intervention group.
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Helth centers of Hamadan
Full name of responsible person
Fereshteh Besharati
Street address
Health Faculty, Hamadan University of Medical Sciences, Shahid Fahmideh Av, Hamadan, Iran.
City
Hamadan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, Hamadan University of Medical Sciences
Full name of responsible person
Saeed Bashirian
Street address
Hamadan University of Medical Sciences, Shahid Fahmideh Av, Hamadan, Iran
City
Hamadan
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, Hamadan University of Medical Sciences
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
Hamadan University of Medical Sciences
Full name of responsible person
Fereshteh Besharati
Position
Master of Sciences/ PhD Student
Other areas of specialty/work
Street address
Hamadan University of Medical Sciences, Shahid Fahmideh A, Hamadan, Iran
City
Hamadan
Postal code
Phone
+98 81 3838 0292
Fax
Email
f.besharati@umsha.ac.irfereshteh.besharati@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Hamadan University of Medical Sciences
Full name of responsible person
Fereshteh Besharati
Position
Master of Sciences/ PhD Student
Other areas of specialty/work
Street address
Hamadan University of Medical Sciences, Shahid Fahmideh Av, Hamadan, Iran
City
Hamadan
Postal code
Phone
+98 81 3838 0292
Fax
Email
f.besharati@umsha.ac.ir fereshteh.besharati@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Hamadan University of Medical Sciences
Full name of responsible person
Fereshteh Besharati
Position
Master of Sciences/ PhD Student
Other areas of specialty/work
Street address
Hamadan University of Medical Sciences, Shahid Fahmideh Av, Hamadan, Iran
City
Hamadan
Postal code
Phone
+98 81 3838 0292
Fax
Email
f.besharati@umsha.ac.ir fereshteh.besharati@yahoo.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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