<?xml version="1.0" encoding="utf-8"?>
<!DOCTYPE trials [
<!ELEMENT trials (trial+)>

<!ELEMENT trial (main,contacts,countries,criteria,health_condition_code,health_condition_keyword,intervention_code,
          intervention_keyword,primary_outcome,secondary_outcome,secondary_sponsor,secondary_ids,source_support,ethics_reviews)>

<!ELEMENT main (trial_id,utrn?,reg_name,date_registration,primary_sponsor,public_title,acronym?,scientific_title,scientific_acronym?,
          date_enrolment,type_enrolment,target_size,recruitment_status,url?,study_type,study_design,phase,hc_freetext?,i_freetext?,results_actual_enrolment,results_date_completed,results_url_link,results_summary,           results_date_posted,results_date_first_publication,results_baseline_char,results_participant_flow,results_adverse_events,results_outcome_measures,results_url_protocol,results_IPD_plan, results_IPD_description)>
<!ELEMENT trial_id (#PCDATA)>
<!ELEMENT utrn (#PCDATA)>
<!ELEMENT reg_name (#PCDATA)>
<!ELEMENT date_registration (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT primary_sponsor (#PCDATA)>
<!ELEMENT public_title (#PCDATA)>
<!ELEMENT acronym (#PCDATA)>
<!ELEMENT scientific_title (#PCDATA)>
<!ELEMENT scientific_acronym (#PCDATA)>
<!ELEMENT date_enrolment (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT type_enrolment (#PCDATA)>
<!ELEMENT target_size (#PCDATA)>
<!ELEMENT recruitment_status (#PCDATA)><!-- Pending,Recruiting,Suspended,Complete,Other -->
<!ELEMENT url (#PCDATA)>
<!ELEMENT study_type (#PCDATA)><!-- interventional,observational -->
<!ELEMENT study_design (#PCDATA)>
<!ELEMENT phase (#PCDATA)>
<!ELEMENT hc_freetext (#PCDATA)>
<!ELEMENT i_freetext (#PCDATA)>
<!ELEMENT results_actual_enrolment (#PCDATA)>
<!ELEMENT results_date_completed (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_url_link (#PCDATA)>
<!ELEMENT results_summary (#PCDATA)>
<!ELEMENT results_date_posted (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_date_first_publication (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_baseline_char (#PCDATA)>
<!ELEMENT results_participant_flow (#PCDATA)>
<!ELEMENT results_adverse_events (#PCDATA)>
<!ELEMENT results_outcome_measures (#PCDATA)>
<!ELEMENT results_url_protocol (#PCDATA)>
<!ELEMENT results_IPD_plan (#PCDATA)>
<!ELEMENT results_IPD_description (#PCDATA)>


<!ELEMENT contacts (contact+)>
<!ELEMENT contact (type,firstname,middlename,lastname,address,city,country1,zip,telephone,email,affiliation)>
<!ELEMENT type (#PCDATA)><!-- Public,Scientific -->
<!ELEMENT firstname (#PCDATA)>
<!ELEMENT middlename (#PCDATA)>
<!ELEMENT lastname (#PCDATA)>
<!ELEMENT address (#PCDATA)>
<!ELEMENT city (#PCDATA)>
<!ELEMENT country1 (#PCDATA)>
<!ELEMENT zip (#PCDATA)>
<!ELEMENT telephone (#PCDATA)>
<!ELEMENT email (#PCDATA)>
<!ELEMENT affiliation (#PCDATA)>

<!ELEMENT countries (country2+)>
<!ELEMENT country2 (#PCDATA)>

<!ELEMENT criteria (inclusion_criteria,agemin,agemax,gender,exclusion_criteria)>
<!ELEMENT inclusion_criteria (#PCDATA)>
<!ELEMENT agemin (#PCDATA)>
<!ELEMENT agemax (#PCDATA)>
<!ELEMENT gender (#PCDATA)>
<!ELEMENT exclusion_criteria (#PCDATA)>

<!ELEMENT health_condition_code (hc_code+)>
<!ELEMENT hc_code (#PCDATA)>

<!ELEMENT health_condition_keyword (hc_keyword+)>
<!ELEMENT hc_keyword (#PCDATA)>

<!ELEMENT intervention_code (i_code+)>
<!ELEMENT i_code (#PCDATA)>

<!ELEMENT intervention_keyword (i_keyword+)>
<!ELEMENT i_keyword (#PCDATA)>

<!ELEMENT primary_outcome (prim_outcome+)>
<!ELEMENT prim_outcome (#PCDATA)>

<!ELEMENT secondary_outcome (sec_outcome+)>
<!ELEMENT sec_outcome (#PCDATA)>

<!ELEMENT secondary_sponsor (sponsor_name+)>
<!ELEMENT sponsor_name (#PCDATA)>

<!ELEMENT secondary_ids (secondary_id+)>
<!ELEMENT secondary_id (sec_id,issuing_authority)>
<!ELEMENT sec_id (#PCDATA)>
<!ELEMENT issuing_authority (#PCDATA)>

<!ELEMENT source_support (source_name+)>
<!ELEMENT source_name (#PCDATA)>

<!ELEMENT ethics_reviews (ethics_review+)>
<!ELEMENT ethics_review (status,approval_date,contact_name,contact_address,contact_phone,contact_email)>
<!ELEMENT status (#PCDATA)><!-- Not approved,Approved,NA -->
<!ELEMENT approval_date (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT contact_name (#PCDATA)>
<!ELEMENT contact_address (#PCDATA)>
<!ELEMENT contact_phone (#PCDATA)>
<!ELEMENT contact_email (#PCDATA)>
]>
<trials>
  <trial>
    <main>
      <trial_id>IRCT20131117015426N8</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-12-17</date_registration>
      <primary_sponsor>Shiraz University of Medical Sciences</primary_sponsor>
      <public_title>The effect of interventions on participation in colorectal cancer screening</public_title>
      <acronym></acronym>
      <scientific_title>Implementation and evaluation of an intervention program based on social marketing theory on participation in colorectal cancer screening</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-12-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>200</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/59645</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Screening, Randomization description: Firstly, 200 samples with having inclusion criteria will be selected using a table of random numbers. Then, a random allocation software will be used to create 50 blocks with a block size of four. in order to create a list of block randomization, refer to following website is done:
https://www.sealedenvelope.com/simple-randomiser/v1/lists. 
Then, based on this generated list (BABA, ABBA, BAAB, BABA, AABB, ...), the subjects will be allocated into the intervention (B) or control (A) groups, Blinding description: In order to perform blinding, assistant researcher who collects data before and after the intervention, as well as statistician who analyzes the data, are blinded to the groups and the assignment of individuals in the groups.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Condition 1: Colon Cancer. Condition 2: Rectom Cancer.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: In this group, an intervention program is designed focusing on the components of the social Marketing Mix or 4P (product, price, place, promotion).This intervention program includes a set of communication, executive  proceedings, educational and informational programs and Transfer effective messages through the preferred communication channels mentioned by the participants to reduce or eliminate barriers and create facilitators to perform the desired behavior, which is participation in fecal immunochemistry, is carried out for one month. To evaluate the effectiveness of the intervention program, three months and 6 months after the intervention, the level of participation in fecal immunochemistry is assessed and compared with the control group. Also, before the interventions and 3 months and 6 months after the interventions, refer to the experimental and control groups again and the champion questionnaire is completed and the mean score of health beliefs about colorectal cancer screening is determined and compared between the two groups. Intervention 2: Control group: In this group, any of the interventions of the intervention group is presented. If participation in this group recourse for a Fecal Immunochemistry test, the test will be done for them. At the end of the research, in order to comply with ethical issues, all the designed training materials will be provided to the control group.</i_freetext>
      <results_actual_enrolment></results_actual_enrolment>
      <results_date_completed></results_date_completed>
      <results_url_link></results_url_link>
      <results_summary></results_summary>
      <results_date_posted></results_date_posted>
      <results_date_first_publication></results_date_first_publication>
      <results_baseline_char></results_baseline_char>
      <results_participant_flow></results_participant_flow>
      <results_adverse_events></results_adverse_events>
      <results_outcome_measures></results_outcome_measures>
      <results_url_protocol></results_url_protocol>
      <results_IPD_plan>Yes - There is a plan to make this available</results_IPD_plan>
      <results_IPD_description>What will be shared:
Primary outcomes would be shared.

When:
Starting 6 months after publication article

To whom:
People and researchers working in academic institutions

Conditions:
Data are provided for information only.

Where to obtain:
Data is available via email hazratishirazy@gmail.com

How to obtain:
Data is available via email hazratishirazy@gmail.com

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Maryam Hazrati</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Nursing and Midwifery University, Namazee Sq, Zand Ave, Shiraz</address>
        <city>Shiraz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7193613119</zip>
        <telephone>+98 71 3647 4258</telephone>
        <email>hazratishirazy@gmail.com</email>
        <affiliation>Shiraz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Maryam Hazrati</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Nursing and Midwifery University, Namazee Sq, Zand Ave, Shiraz</address>
        <city>Shiraz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7193613119</zip>
        <telephone>+98 71 3647 4258</telephone>
        <email>hazratishirazy@gmail.com</email>
        <affiliation>Shiraz University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Persons over 50 years old age (persons at average risk)
Willingness to participate in the study
Residence in Yasuj city</inclusion_criteria>
      <agemin>50 years</agemin>
      <agemax>70 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Self-report of a positive history of colorectal cancer or polyps
Participation in previous training programs related to colorectal cancer screening
Persons over 70 years old age</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>C18.9</hc_code>
      <hc_code>C20</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Malignant neoplasm of colon, unspecified</hc_keyword>
      <hc_keyword>Malignant neoplasm of rectum</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Prevention</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: In this group, an intervention program is designed focusing on the components of the social Marketing Mix or 4P (product, price, place, promotion).This intervention program includes a set of communication, executive  proceedings, educational and informational programs and Transfer effective messages through the preferred communication channels mentioned by the participants to reduce or eliminate barriers and create facilitators to perform the desired behavior, which is participation in fecal immunochemistry, is carried out for one month. To evaluate the effectiveness of the intervention program, three months and 6 months after the intervention, the level of participation in fecal immunochemistry is assessed and compared with the control group. Also, before the interventions and 3 months and 6 months after the interventions, refer to the experimental and control groups again and the champion questionnaire is completed and the mean score of health beliefs about colorectal cancer screening is determined and compared between the two groups.</i_keyword>
      <i_keyword>Control group: In this group, any of the interventions of the intervention group is presented. If participation in this group recourse for a Fecal Immunochemistry test, the test will be done for them. At the end of the research, in order to comply with ethical issues, all the designed training materials will be provided to the control group.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Colorectal Cancer Screening. Timepoint: Before, 3 and 6 months  after the intervention. Method of measurement: Participation rate in Fecal Immunochemistry Test.</prim_outcome>
      <prim_outcome>Health Beliefs. Timepoint: 3 and 6 months after the intervention. Method of measurement: Champion's Health Belief Scale.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome></sec_outcome>
    </secondary_outcome>
    <secondary_sponsor>
      <sponsor_name></sponsor_name>
    </secondary_sponsor>
    <secondary_ids>
      <secondary_id>
        <sec_id></sec_id>
        <issuing_authority></issuing_authority>
      </secondary_id>
    </secondary_ids>
    <source_support>
      <source_name>Shiraz University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-04-05</approval_date>
        <contact_name>Ethic Committee of Shiraz University of Medical Sciences</contact_name>
        <contact_address>Vice chancellor for research affairs, seven floor, Shiraz University of Medical Science, beside Helal Ahmar, Zand Ave, Shiraz, Iran Shiraz Fars Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
