<?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>IRCT20230128057252N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-07-08</date_registration>
      <primary_sponsor>Jahrom University of Medical Sciences</primary_sponsor>
      <public_title>The effects nurse supportive care delivery on mood states, general health and competence of caregivers of patients undergoing chemotherapy</public_title>
      <acronym></acronym>
      <scientific_title>Investigating the effects supportive care delivery on mood states, general health and competence of caregivers of cancer patients undergoing chemotherapy</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-07-06</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/69729</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: First, a call will be made in the chemotherapy department. After that, 60 people will be selected from among the volunteers who meet the Word criteria using the Random Number Generator software, and then random allocation will be done into two groups with the help of the previous software from among the 60 selected people, Blinding description: The filling of the questionnaires will be done by the research assistant  and the data analysor will be done by the statistical expert blindly
Nurses provider routine care and person who will collect data in the study selection will also be blinded.</study_design>
      <phase>N/A</phase>
      <hc_freetext>CAREGIVERS OF CANCER PATIENTS.</hc_freetext>
      <i_freetext>Intervention 1: For the intervention group: supportive care will be provided for 8 weeks. Intervention steps: 1- Checking the initial evaluation results with questionnaires in the intervention group. 2- Holding training and counseling sessions in small groups (5-7 people) based on the common needs of caregivers, at least 8 sessions for each group (1 session per week). The location of the meetings was inside the chemotherapy department or one of the conference rooms of the hospital. Educational content includes: disease symptom management, stress management, fatigue management, pain control, nutrition maintenance, home care, psychological distress management. 3-Individual training based on the special needs of people if the caregiver declares. 4-Providing a booklet prepared according to the unique needs of caregivers among cancer patients according to scientific sources. Weekly telephone follow-up regarding the provided training and new needs and performing the recommended care. At least 2 times per week 6- Forming a virtual group with the aim of greater interaction and providing educational videos and CDs based on the unique needs of caregivers. Intervention 2: Control group: For the control group: the usual treatments of the chemotherapy department (chemotherapy - doctor's visit if necessary and nurse's visit) were performed.</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 data can be shared after de-identifying samples

When:
Access 6 months after results are printed

To whom:
Only for researchers working in academic and scientific institutions

Conditions:
Meta-analysis is allowed

Where to obtain:
mohsen hojat
mohsenhojat.mh@gmail.com
0098 9307915244

How to obtain:
6 months after the publication of the article, contact the COrespond author's email (Dr. Hojjat) and receive it as soon as possible

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mohsen Hojat</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Second floor, Nursinh faculty,  Jahrom University of Medical Sciences, Motahari street</address>
        <city>Jahrom</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7414846199</zip>
        <telephone>0098 71543405</telephone>
        <email>mohsenhojat.mh@gmail.com</email>
        <affiliation>Jahrom University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>mohsen hojat</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Second floor, Nursinh faculty,  Jahrom University of Medical Sciences, Motahari street</address>
        <city>Jahrom</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7414846199</zip>
        <telephone>0098 71543405</telephone>
        <email>mohsenhojat.mh@gmail.com</email>
        <affiliation>Jahrom University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Age: older than18 years old
The main caregiver of a patient undergoing chemotherapy
No health personnel
Not taking care of another chronic patient at the same time
Having the ability Physical and mental to participate in the study</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Significant emotional distress
Reluctance to continue cooperation,
Discontinuation of cooperation in patient care
Death of the patient</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code></hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword></hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Behavior</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>For the intervention group: supportive care will be provided for 8 weeks. Intervention steps: 1- Checking the initial evaluation results with questionnaires in the intervention group. 2- Holding training and counseling sessions in small groups (5-7 people) based on the common needs of caregivers, at least 8 sessions for each group (1 session per week). The location of the meetings was inside the chemotherapy department or one of the conference rooms of the hospital. Educational content includes: disease symptom management, stress management, fatigue management, pain control, nutrition maintenance, home care, psychological distress management. 3-Individual training based on the special needs of people if the caregiver declares. 4-Providing a booklet prepared according to the unique needs of caregivers among cancer patients according to scientific sources. Weekly telephone follow-up regarding the provided training and new needs and performing the recommended care. At least 2 times per week 6- Forming a virtual group with the aim of greater interaction and providing educational videos and CDs based on the unique needs of caregivers.</i_keyword>
      <i_keyword>Control group: For the control group: the usual treatments of the chemotherapy department (chemotherapy - doctor's visit if necessary and nurse's visit) were performed.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Mood state. Timepoint: Before starting the study - immediately after the intervention - 1 month after the intervention. Method of measurement: PROFILE OF MOOD STATES (POMS).</prim_outcome>
      <prim_outcome>General health. Timepoint: Before starting the study - immediately after the intervention - 1 month after the intervention. Method of measurement: General health questionnaire.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Caregiver competency. Timepoint: Before starting the study - immediately after the intervention - 1 month after the intervention. Method of measurement: Caregiver competence Scale.</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>Jahrom University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-01-29</approval_date>
        <contact_name>Ethics Committee of Jahrom University of Medical Sciences</contact_name>
        <contact_address>Jahrom University of Medical Sciences. Mtahari St. Jahrom Fars Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
