<?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>IRCT20150902023861N9</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-02-13</date_registration>
      <primary_sponsor>Iran University of Medical Sciences</primary_sponsor>
      <public_title>The effect of individual nutrition counseling and family education on improving life and weight changes in patients with gastric cancer after total gastrectomy</public_title>
      <acronym></acronym>
      <scientific_title>The effect of individual nutrition counseling and family education on quality of life, sleep, weight changes, stress, anxiety and depression in patients with gastric cancer after total gastrectomy</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-06-05</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>66</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/62792</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Other design features: Educational and Guidance, Randomization description: For the random allocation of people, it will be done using the minimization method based on gender variables and in the form of balanced blocks. For this purpose, we have 6 pages of paper, on 3 of which the word I, which stands for Intervention, and on 3 of them, the word C, which stands for Control, is written. Then these are placed in a container and randomly extracted from this information box of these people until six pieces of paper are extracted from this package. Again, this operation is repeated until all the sample volume is taken.
Then the participants in the selected blocks will be selected in a balanced way and based on gender according to the predetermined table. To balance the blocks based on sex, two pieces of paper written one of them with the word F, which stands for female, and the other with the word M, which stands for male, are then placed in the compartment and drawn randomly by replacing so that the ratio of women to men is considered to be 2 to 1 in the first block of 6 tuple and 1 to 2 in the next block of 6 tuple until the end, for this purpose the first half of the block of 6 tuple where the ratio of women to men is 2 to 1 If the first two people are randomly selected as men, in order to maintain the ratio of 2 to 1, we will consider the third person as a woman. We will determine the second half of the block based on the first half of the block. In the next block of 6 tuple, this time the ratio is reversed and the ratio of women to men is considered 1 to 2. Again, the lot is drawn by replacing and if the first person is a woman and the second person is a man, the third person is chosen as a woman to maintain the ratio, and this process continues until the end.
The gender variable is considered a potentially confounding variable and the minimization method was used for the least confounding effect in the study.
According to previous similar studies and research objectives, randomization will be done based on gender.</study_design>
      <phase>N/A</phase>
      <hc_freetext>gastric cancer.</hc_freetext>
      <i_freetext>Intervention 1: The intervention group receives individual nutrition counseling and training from family members. Patients in Imam Khomeini Hospital are admitted to the study after total gastrectomy according to the research criteria. After surgery and stabilization, a face-to-face training session is held with the patient and preferably with the participation of close relatives. After discharge, a weekly individual diet plan for each patient and training on how to deal with and reduce postoperative complications. The protocol procedure will be performed according to the American gastrectomy guideline. During the week, the necessary follow-ups and answering of the patient's questions will be done via video calls. In addition, the patient's companions will be trained once every two weeks. At the beginning of the study, patients are evaluated through questionnaires at weeks 4 and 8. Intervention 2: Control group: Without any nutrition intervention, During hospitalization, patients routinely receive general nutrition education related to gastrectomy from the treatment staff. This group is also evaluated at the beginning of the study and during the 4th and 8th weeks.</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>No - There is not a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for not sharing IPD is There is no further information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Dr.Mitra Zarrati</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Tehran, Hemmat Highway next to Milad Tower, Iran University of Medical Sciences, school of public health, nutrition department</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1449614535</zip>
        <telephone>+98 21 8670 4814</telephone>
        <email>zarrati.m@iums.ac.ir</email>
        <affiliation>Iran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mitra Zarrati</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>hemmat highway</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1449614535</zip>
        <telephone>+98 21 8670 4814</telephone>
        <email>zarrati.m@iums.ac.ir</email>
        <affiliation>Iran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Diagnosis of gastric cancer
Age between 20 to 65 years
Total gastrectomy</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>65 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Patients with chronic diseases such as cardiovascular,Mental illness or disturbance of consciousness
Cancer metastasis to other organs (end stage (IV) gastric cancer)
Diseases that may affect their nutritional status, such as diabetes
Long-term hospitalization.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>C16</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Malignant neoplasm of stomach</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Lifestyle</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>The intervention group receives individual nutrition counseling and training from family members. Patients in Imam Khomeini Hospital are admitted to the study after total gastrectomy according to the research criteria. After surgery and stabilization, a face-to-face training session is held with the patient and preferably with the participation of close relatives. After discharge, a weekly individual diet plan for each patient and training on how to deal with and reduce postoperative complications. The protocol procedure will be performed according to the American gastrectomy guideline. During the week, the necessary follow-ups and answering of the patient's questions will be done via video calls. In addition, the patient's companions will be trained once every two weeks. At the beginning of the study, patients are evaluated through questionnaires at weeks 4 and 8.</i_keyword>
      <i_keyword>Control group: Without any nutrition intervention, During hospitalization, patients routinely receive general nutrition education related to gastrectomy from the treatment staff. This group is also evaluated at the beginning of the study and during the 4th and 8th weeks.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Quality of Life. Timepoint: before intervention and 4, 8 weeks after intervention. Method of measurement: QLQ-STO22 and QLQ-C30 quality of life questionnaires.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Sleep quality. Timepoint: before intervention and 4 , 8 weeks after intervention. Method of measurement: Peters burg Sleep Quality Questionnaire (PSQI).</sec_outcome>
      <sec_outcome>General Health. Timepoint: before intervention and 4 , 8 weeks after intervention. Method of measurement: General Health Questionnaire (GHQ).</sec_outcome>
      <sec_outcome>Stress-Depression-Anxiety. Timepoint: before intervention and 4 , 8 weeks after intervention. Method of measurement: Stress Anxiety Depression Scale (DASS).</sec_outcome>
      <sec_outcome>Nutritional status of cancer patients. Timepoint: before intervention and 4 , 8 weeks after intervention. Method of measurement: The Patient-Generated Subjective Global Assessment Questionnaire.</sec_outcome>
      <sec_outcome>Weight changes. Timepoint: before intervention and 4 , 8 weeks after intervention. Method of measurement: Weight (kg), waist and hip circumference (cm).</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>Iran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-05-08</approval_date>
        <contact_name>Ethics Committee of Iran University of Medical Sciences</contact_name>
        <contact_address>Iran University of Medical Sciences, next to the Milad hospital, the intersection of Sheikh Fazlallah and Shahid Chamran, Hemmat expressway Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
