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
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

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
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
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