<?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>IRCT20241022063461N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2025-01-22</date_registration>
      <primary_sponsor>Tehran University of Medical Sciences</primary_sponsor>
      <public_title>Digital storytelling in cancer</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of the Effectiveness of Digital Storytelling by Peers and Routine Treatment on Changes in Self-Efficacy and Rumination in Individuals with Colorectal Cancer.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2025-08-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>70</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/79764</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Not randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Blinding description: Due to the possibility of intervention leakage, the control group participants will enter the study first, and after a short break and the discharge of the last control group participant, the intervention group participants will enter the study.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Colorectal cancer.</hc_freetext>
      <i_freetext>Intervention 1: The intervention group: this intervention offers participants, in addition to routine care, the opportunity to participate in digital storytelling sessions aimed at improving self-efficacy and reducing rumination. These sessions will be held weekly over four weeks, focusing on storytelling films created by peers and overseen by specialists. During the sessions, participants will familiarize themselves with group norms and provide feedback on their own and others' experiences, while relevant scientific recommendations will be offered at each session. The meetings will include 14 to 16 participants, peers, a senior researcher, and a psychologist, conducted online at times chosen by the patients .To create digital stories, specific guidelines will be provided to selected individuals, who will be asked to write scenarios based on their experiences. These scenarios will then be reviewed by specialists and transformed into films. The production stages will include identifying images, creating a story flowchart, and combining the final media elements. At the end of the program, transportation costs for peers will be covered, and gifts will be presented as a form of appreciation. Intervention 2: Control group: They will receive standard care, which includes routine self-care education provided by a nurse during care procedures or at discharge. It is important to note that the control group will be followed up by phone every two weeks to assess if they meet the exit criteria for the study, at which point they may be removed from the study. One month after participating in the research, contact will be made with the research units, and the questionnaires will be completed again.</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:
- Contributors' Data File (All Data)  
- Clinical Study Report (All Data)  
- Informed Consent Form (All Data)

When:
Access will begin in the Spring of 2025.

To whom:
Researchers employed in academic and scientific institutions.

Conditions:
In case of using the data in scientific research

Where to obtain:
Sajjad Soofi
sajjadsoofi205@gmail.com

How to obtain:
Applicants can submit their requests via email, and a response will be provided within a maximum of 24 hours after receiving the email.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Sajjad Soofi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Unit3, Mahestan Complex5, Boustan Alley, Saadi Street, Phase 2, Farhangian Town.</address>
        <city>Hamadan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6519992517</zip>
        <telephone>+98 81 3256 5624</telephone>
        <email>s-soofi@razi.tums.ac.ir</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Sajjad Soofi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Unit3, Mahestan Complex5, Boustan Alley, Saadi Street, Phase2, farhangian Town.</address>
        <city>Hamadan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6519992517</zip>
        <telephone>+98 81 3256 5624</telephone>
        <email>s-soofi@razi.tums.ac.ir</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Individuals aged 18 to 65 with stage I-III colorectal cancer
Willingness to participate in the research
Proficiency in the Persian language
Possession of and ability to use a smartphone
Access to the internet and social media
Having at least basic literacy skills (reading and writing)</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>65 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Having recurrent or metastatic colorectal cancer
Suffering from known cognitive or psychiatric disorders as reported by the patient
Suffering from physical disabilities such as blindness or deafness
Addiction to drugs, alcohol, or psychoactive substances</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>C19</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Malignant neoplasm of rectosigmoid junction</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>The intervention group: this intervention offers participants, in addition to routine care, the opportunity to participate in digital storytelling sessions aimed at improving self-efficacy and reducing rumination. These sessions will be held weekly over four weeks, focusing on storytelling films created by peers and overseen by specialists. During the sessions, participants will familiarize themselves with group norms and provide feedback on their own and others' experiences, while relevant scientific recommendations will be offered at each session. The meetings will include 14 to 16 participants, peers, a senior researcher, and a psychologist, conducted online at times chosen by the patients .To create digital stories, specific guidelines will be provided to selected individuals, who will be asked to write scenarios based on their experiences. These scenarios will then be reviewed by specialists and transformed into films. The production stages will include identifying images, creating a story flowchart, and combining the final media elements. At the end of the program, transportation costs for peers will be covered, and gifts will be presented as a form of appreciation.</i_keyword>
      <i_keyword>Control group: They will receive standard care, which includes routine self-care education provided by a nurse during care procedures or at discharge. It is important to note that the control group will be followed up by phone every two weeks to assess if they meet the exit criteria for the study, at which point they may be removed from the study. One month after participating in the research, contact will be made with the research units, and the questionnaires will be completed again.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>The self-efficacy score in the General Self-Efficacy Questionnaire. Timepoint: Pre-test, immediately after, and one month later. Method of measurement: Scherer and Maddux General Self-Efficacy Questionnaire.</prim_outcome>
      <prim_outcome>The rumination score in the Nolen-Hoeksema and Morrow Rumination Questionnaire. Timepoint: Pre-test, immediately after, and one month later. Method of measurement: Nolen-Hoeksema and Morrow Rumination Questionnaire.</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>Tehran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2024-10-06</approval_date>
        <contact_name>Research Ethics Committees of School of Nursing and Midwifery &amp; Rehabilitation; Tehran University of</contact_name>
        <contact_address>13th Floor, Block A, Central Headquarters of the Ministry of Health, Treatment and Medical Education, Simaye Iran Street, Between Falamak Jonubi and Zarafshan, Shahrak-e Quds (West), Iran. Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
