<?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>IRCT20170514033961N11</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2025-04-27</date_registration>
      <primary_sponsor>Khoram-Abad University of Medical Sciences</primary_sponsor>
      <public_title>The effect of patient-centered education on the self-care ability and quality of life of the elderly with gastrointestinal cancers</public_title>
      <acronym></acronym>
      <scientific_title>The effect of patient-centered education on the self-care ability and quality of life of the elderly with gastrointestinal cancers</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2025-05-05</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>70</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/82315</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: The allocation of samples to groups is done using the Block Randomization method. In order to equalize the distribution of confounding variables of cancer type (gastric cancer, esophageal cancer, colon cancer, and colorectal cancer), first, classes are created based on these variables, such as female/male class and cancer based on metastatic or non-metastatic, and then the block randomization method is used to assign patients to two groups using random blocks of 4. 6 different combinations of 4-blocks (AABB- ABAB- ABBA- BBAA- BABA- BAAB) are created and randomly selected using the Blockrand package of R software, and the random sequence will be formed as a sequence of letters A and B.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Condition 1: Gastrointestinal (esophagus) cancer. Condition 2: Gastrointestinal (stomach) cancer. Condition 3: Gastrointestinal (colon) cancer. Condition 4: Gastrointestinal (rectal) cancer.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: In this group, the educational intervention for patients will consist of 8 30- to 45-minute sessions, both in-person and virtual. The sessions will be held at weekly intervals, one-on-one, both in-person and virtual. Each educational session will include a lecture and a question and answer session. Educational brochures will also be provided to them. Intervention 2: Control group: In this group, an intensive training session is held after the final stage of data collection.</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:
All potential data is released after unidentifiable individuals in the form of original message information.

When:
The access period will start 6 months after printing.

To whom:
All researchers, lecturers, medical students can receive the published article from the relevant journal.

Conditions:
Unidentifiable data will be made available to health researchers for the study of meta-analysis

Where to obtain:
Send Saki Mandana an email m.saki@modares.ac.ir

How to obtain:
After sending the documents by the applicant's researcher via email, the data will be send two weeks later.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mandana Saki</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>5 km of Khorram Abad-Boroujerd road</address>
        <city>Khorramabad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6819834525</zip>
        <telephone>+98 66 3331 6465</telephone>
        <email>mandana_saki@yahoo.com</email>
        <affiliation>Khoram-Abad University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mandana Saki</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>5 km of Khorram Abad-Boroujerd road</address>
        <city>Khorramabad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6819834525</zip>
        <telephone>+98 66 3331 6465</telephone>
        <email>mandana_saki@yahoo.com</email>
        <affiliation>Khoram-Abad University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Over 60 years of age
Having metastatic or non-metastatic gastrointestinal cancer (such as stomach cancer, esophageal cancer, colon cancer, and colorectal cancer)
At least one session has passed and at least 6 sessions of chemotherapy remain.
Smartphone access
Adequate hearing and vision ability</inclusion_criteria>
      <agemin>60 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Unwillingness to continue cooperation
Oncology emergencies
Patients in need of palliative care
Having known mental illnesses (bipolar, etc.) or having dementia
Abrupt discontinuation of treatment at the discretion of the physician or patient, death, or migration</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>C15</hc_code>
      <hc_code>C16</hc_code>
      <hc_code>C18</hc_code>
      <hc_code>C20</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Malignant neoplasm of esophagus</hc_keyword>
      <hc_keyword>Malignant neoplasm of stomach</hc_keyword>
      <hc_keyword>Malignant neoplasm of colon</hc_keyword>
      <hc_keyword>Malignant neoplasm of rectum</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: In this group, the educational intervention for patients will consist of 8 30- to 45-minute sessions, both in-person and virtual. The sessions will be held at weekly intervals, one-on-one, both in-person and virtual. Each educational session will include a lecture and a question and answer session. Educational brochures will also be provided to them.</i_keyword>
      <i_keyword>Control group: In this group, an intensive training session is held after the final stage of data collection.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Quality of life. Timepoint: Before the start of the intervention and two weeks after the end of the intervention. Method of measurement: Quality of Life Questionnaire-Core 30.</prim_outcome>
      <prim_outcome>Self-care ability. Timepoint: Before the start of the intervention and two weeks after the end of the intervention. Method of measurement: Questionnaire to assess the ability of self-care specifically for patients with colorectal cancer.</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>Khoram-Abad University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2025-03-05</approval_date>
        <contact_name>Ethics Committee of Lorestan University of Medical Sciences</contact_name>
        <contact_address>Vice Chancellor for Research and Technology, Lorestan University of Medical Sciences University Campus Complex, Khorramabad-Borujerd Road, Khorramabad, Lorestan Khorramabad Lorestan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
