<?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>IRCT20210331050795N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-06-21</date_registration>
      <primary_sponsor>Yasouj University of Medical Sciences</primary_sponsor>
      <public_title>The effect of Happiness Educational Program of Fordyce on the sense of coherence and psychological well-being of adolescents who have a parent with cancer</public_title>
      <acronym></acronym>
      <scientific_title>The effect of Happiness Educational Program of Fordyce on the sense of coherence and psychological well-being of adolescents who have a parent with cancer</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-06-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>92</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/56763</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: The random assignment of a block will be such that first by multiplying the number of groups studied (two groups) by 2, the number of samples of each block is calculated equal to 4, then by factorial calculation, the number of samples of each block (4! = 4 × 3 × 2 × 1= 24), the number of blocks resulting from all states of arrangement of individuals, 24 calculated blocks and blocks involving the possible arrangement of individuals considering A (gray manikin) for the intervention group and B (white manikin) for the control group will be. Then, since the number of people in each block is 4 people and the estimated sample size is 92 people, so by matching 18 random numbers produced by Sample Randomizer software with the number of the above cases, how to arrange 92 people research sample and assign each number from 1 to 92 to one of the specific intervention or control groups and a block random allocation list will be compiled. Eligible research samples, based on the time priority of the referral, will be assigned a code to each of them, by matching that number with the block random allocation list, the adolescents participating in the research will be assigned to one of the intervention or control groups. This process will continue until the estimated sample size is completed.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Cancer.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: The number of sessions in the intervention group will be 6 sessions of 60 minutes and one day a week for 6 weeks. The interventions will be performed in groups and in groups of 5 to 10 people. The Fordyce Happiness training program will be implemented by the researcher using the methods of lectures, group discussions, questions and answers, and thoughts. The following will be briefly mentioned in 6 sessions: Session 1: Defining happiness, its necessity and importance, Session 2: Training to spend more time in communities and group activities, Session 3: Principles of better planning and organization, Session Fourth: Teaching the principles of positive and optimistic thinking, Session 5: Teaching the principles of cultivating social and extroverted personality and Session 6: Teaching the principles of sincere communication as the most important source of happiness. Intervention 2: Control group: Non-intervention: This training group will not be given.</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>Undecided - It is not yet known if there will be a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for indecision in sharing IPD is No more information.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Razieh Forutannasab</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 20, Sub-Branch 7, Ibn Sina St., Terminal</address>
        <city>Yasuj</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7591961919</zip>
        <telephone>+98 74 3322 2524</telephone>
        <email>razie2624@gmail.com</email>
        <affiliation>Yasouj University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Razieh Forutannasab</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 20, Sub-Branch 7, Ibn Sina St., Terminal</address>
        <city>Yasuj</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7591961919</zip>
        <telephone>+98 74 3322 2524</telephone>
        <email>razie2624@gmail.com</email>
        <affiliation>Yasouj University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Consent to participate in the study and sign the informed consent form by the parent and adolescent
One of the parents has cancer
At least six months have passed since the definitive diagnosis of parental cancer by an oncologist
Simultaneously obtaining a score of 52 or less in the Antonovsky's Sense of Coherence Questionnaire-13 and Ryff's scale of Psychological well-being-18</inclusion_criteria>
      <agemin>13 years</agemin>
      <agemax>18 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Lack of adolescent awareness of parental cancer
Simultaneous infection of a teenager or a first-degree member of his family with other incurable diseases
Simultaneous infection of a teenager or a first-degree member of his family with mental illness
Both parents have cancer
History of participating in similar training courses in the last six months</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>C80.0</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Malignant neoplasm, without specification of site</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Lifestyle</i_code>
      <i_code>Lifestyle</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: The number of sessions in the intervention group will be 6 sessions of 60 minutes and one day a week for 6 weeks. The interventions will be performed in groups and in groups of 5 to 10 people. The Fordyce Happiness training program will be implemented by the researcher using the methods of lectures, group discussions, questions and answers, and thoughts. The following will be briefly mentioned in 6 sessions: Session 1: Defining happiness, its necessity and importance, Session 2: Training to spend more time in communities and group activities, Session 3: Principles of better planning and organization, Session Fourth: Teaching the principles of positive and optimistic thinking, Session 5: Teaching the principles of cultivating social and extroverted personality and Session 6: Teaching the principles of sincere communication as the most important source of happiness.</i_keyword>
      <i_keyword>Control group: Non-intervention: This training group will not be given.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Sense of Coherence. Timepoint: Adolescents' sense of Coherence at the beginning of the study (before the intervention) and immediately after the start of the study. Method of measurement: Antonovsky's Sense of Coherence Questionnaire-13.</prim_outcome>
      <prim_outcome>Psychological well-being. Timepoint: Adolescents' psychological well-being at the beginning of the study (before the intervention) and immediately after the start of the study. Method of measurement: Ryff's scale of Psychological well-being-18.</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>Yasouj University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-06-02</approval_date>
        <contact_name>Ethics committee of Yasuj University of Medical Sciences</contact_name>
        <contact_address>Yasuj University of Medical Sciences, Shahid Motahari Blvd., Yasuj, Kohgiluyeh and Boyer-Ahmad, Islamic Republic of Iran Yasuj Kohgilouyeh-va-Boyrahmad Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
