1
Clinical Trial Protocol
Iranian Registry of Clinical Trials
06 Nov 2022
The Effect of Educational Intervention based on Extended Parallel Model for Participatory Peopele Referring to Health Centers in the Bandar Anzali countyin Colorectal Cancer Screening Programs
Protocol summary
Study aim
The present study is an experimental study that will be carried out on people referring to Bandar Anzali Health Centers. The inclusion criteria are including: aged 40 years and older, are non-cancerous, have no history of colorectal cancer in family members and be inhabit in Bandar Anzali (city or village). In this study, people who refer to health centers of Bandar Anzali will divide in two groups of intervention and comparison through random allocation method(block balanced randomize ).
Educational Intervention will be based on extended parallel threat model for the intervention group and the comparison group just will be given educational brochures. In case of referral of the individuals in both groups, three consecutive fecal occult blood test will be performed. Three months after the educational
intervention , the questionnaires will be completed by two groups and will be analyzed by SPSS software. The present study is designed using a extended parallel threat model for effective intervention to motivate people for participating in colorectal cancer screening.
Design
Two arm parallel group randomised trial Settings and conduct
Health Centers in the Bandar Anzali county Participants/Inclusion and exclusion criteria
Age=>40, both male and female Intervention groups
Educational intervention is based on the Extended Parallel Process Model for participation in the Colorectal Cancer screening program. The fear-based messages based on three-part 45-minute sessions are presented to the intervention group. The comparison group received only a brochure in this regard. They will be given three months to participate in a free screening of fecal occult blood testing (FOBT) three times consecutively.
Main outcome variables
Perform stool test three consecutive times
General information
Reason for update Acronym
IRCT registration information
IRCT registration number: IRCT20161116030923N4 Registration date: 2018-05-21, 1397/02/31
Registration timing: retrospective
Last update: 2018-05-21, 1397/02/31 Update count: 0
Registration date 2018-05-21, 1397/02/31 Registrant information
Name
Name of organization / entity Country
Iran (Islamic Republic of) Phone
+98 26 3355 5670 Email address
l.sabzmakan@abzums.ac.ir Recruitment status
Recruitment complete Funding source
Expected recruitment start date 2016-10-22, 1395/08/01
Expected recruitment end date 2017-01-20, 1395/11/01 Actual recruitment start date
2016-10-21, 1395/07/30 Actual recruitment end date
2017-01-19, 1395/10/30 Trial completion date
2 empty
Scientific title
The Effect of Educational Intervention based on Extended Parallel Model for Participatory Peopele Referring to Health Centers in the Bandar Anzali countyin Colorectal Cancer Screening Programs
Public title
Participatory Colorectal Cancer Screening Programs Purpose
Prevention
Inclusion/Exclusion criteria Inclusion criteria:
age=>40 The desire to participate in the study no cancer No history of colorectal cancer in the first-degree family living in the Bandar Anzali county
Exclusion criteria:
having special illness Age
From 40 years old Gender
Both Phase
N/A
Groups that have been masked No information
Sample size
Target sample size: 154
Actual sample size reached: 168 Randomization (investigator's opinion)
Randomized
Randomization description
Randomization method is the block balanced randomize and individual. For making randomization sequence the web site of www.randomization.com is used. There are two groups ( intervention & comparison) and, we use the labels of letters A and B. Therefore, size of each block is twice the number of groups, that is, 4. The number of blocks is determined by dividing the sample size by the size of the block. The sample size is 168 people, each group is 84, and the number of blocks in each group is 21 blocks, each of which blocks the assignment of 4 persons. In this website, we specify an ID number and a list is provided for 168 persons. To concealment, write the letters A and B in the order indicated on the cards and place them in thick envelopes and write serial numbers on the envelopes. Because we collect samples from four health centers, we provide a list for each center, and because the sex variable is a confounding, a stratified randomization will also be used.
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 Alborz University of Medical Sciences
Street address
45 metri golshahr Ave, shahid saffarian City
Karaj Province
Alborz Postal code
3198764653 Approval date
2016-06-07, 1395/03/18
Ethics committee reference number Abzums.Rec.1395.34
Health conditions studied
1
Description of health condition studied the prevention of colorectal cancer ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Performing three consecutive fecal occult blood testing (FOBT)
Timepoint
Three months after educational intervention Method of measurement
To measure the primary outcome is three times the focal test
Secondary outcomes
1
Description
perceived susceptibility and severity Timepoint
Before educational intervention- after three months educational intervention
Method of measurement
questionnaire that was developed based on constructs of Extended Parallel Process Model
3
2
Description
self-efficacy and response efficacy Timepoint
Before educational intervention- after three months educational intervention
Method of measurement
questionnaire that was developed based on constructs of Extended Parallel Process Model
Intervention groups
1
Description
Intervention group: The intervention group participates in three 45-minute educational sessions once a week in health centers. In the intervention group, individuals for the group education will be divided into groups of 8 to 10 people (men and women separately) . Educational sessions are based on the extended parallel process model.
Category Prevention
2
Description
Control group: This group only provides a brochure for colorectal cancer and stool screening tests. Both groups have three months to participate in the fecal screening program three consecutive times.
Category Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
community health centers of Bandar Anzali Full name of responsible person
hajar khatami Street address
gilan- bandaranzali City
Bandar Anzali Province
Guilan Postal code
31987646653 Phone
+98 26 3355 5670 Email
sabzmakan@yahoo.com
Sponsors / Funding sources
1 Sponsor
Name of organization / entity Karaj University of Medical Sciences Full name of responsible person
Mohammad norisepehr Street address
shahid saffrian City
karaj Province
Alborz Postal code
3198764653 Phone
+98 26 3464 3922 Fax
+98 26 3464 3822 Email
dr.noorisepehr@abzums.ac.ir Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Karaj University of Medical Sciences Proportion provided by this source
10
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 Karaj University of Medical Sciences Full name of responsible person
leila sabzmakan Position
faculty member Latest degree
Ph.D.
Other areas of specialty/work Health Promotion
Street address shahid saffarian City
karaj Province
Alborz Postal code
3183744439 Phone
+98 26 3464 3922
4 Email
sabzmakan@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity Karaj University of Medical Sciences Full name of responsible person
leila sabzmakan Position
assistance professor Latest degree
Ph.D.
Other areas of specialty/work Health Promotion
Street address shahid saffarian City
karaj Province
Alborz Postal code
3183744439 Phone
+98 26 3355 5670 Email
sabzmakan@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity Karaj University of Medical Sciences Full name of responsible person
leila Position
assistance professor Latest degree
Ph.D.
Other areas of specialty/work Health Promotion
Street address shahid saffarian City
karaj Province
Alborz Postal code
3183744439 Phone
+98 26 3355 5670 Email
sabzmakan@yahoo.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
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report Not applicable Analytic Code
Not applicable Data Dictionary Not applicable
