Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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IRCT |
Last refreshed on:
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18 June 2018 |
Main ID: |
IRCT20161116030923N4 |
Date of registration:
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2018-05-21 |
Prospective Registration:
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No |
Primary sponsor: |
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Public title:
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Participatory Colorectal Cancer Screening Programs
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Scientific title:
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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 |
Date of first enrolment:
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2016-10-22 |
Target sample size:
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154 |
Recruitment status: |
Complete |
URL:
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http://en.irct.ir/trial/24431 |
Study type:
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interventional |
Study design:
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Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, 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 p
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Phase:
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N/A
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Countries of recruitment
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Iran (Islamic Republic of)
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Contacts
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Name:
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leila sabzmakan
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Address:
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shahid saffarian
3183744439
karaj
Iran (Islamic Republic of) |
Telephone:
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+98 26 3464 3922 |
Email:
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sabzmakan@yahoo.com |
Affiliation:
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Karaj University of Medical Sciences |
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Name:
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leila sabzmakan
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Address:
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shahid saffarian
3183744439
karaj
Iran (Islamic Republic of) |
Telephone:
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+98 26 3355 5670 |
Email:
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sabzmakan@yahoo.com |
Affiliation:
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Karaj University of Medical Sciences |
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Key inclusion & exclusion criteria
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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 minimum:
40 years
Age maximum:
no limit
Gender:
Both
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Health Condition(s) or Problem(s) studied
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the prevention of colorectal cancer.
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Intervention(s)
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Intervention 1: 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. Intervention 2: 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.
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Primary Outcome(s)
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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.
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Secondary Outcome(s)
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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.
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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.
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Source(s) of Monetary Support
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Karaj University of Medical Sciences
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Ethics review
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Status: Approved
Approval date:
Contact:
Ethics committee of Alborz University of Medical Sciences
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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