<?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>IRCT2016102430465N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2016-12-18</date_registration>
      <primary_sponsor>Vice Chancellor for Research ofArak University of Medical Sciences</primary_sponsor>
      <public_title>Effect of telephone intervention on supportive care  needs of  patients with cancer</public_title>
      <acronym></acronym>
      <scientific_title>Effect of telephone support on supportive care needs of women with breast cancer</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2016-10-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>62</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/24194</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Other design features: using randomized block design.</study_design>
      <phase>N/A</phase>
      <hc_freetext>breast cancer.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Telephone intervention will be performed for a month. The first contact with participants will be done during a week after the first meeting. The researcher will call patients in the intervention group twice a week, and they can also get in touch with the researcher if they have any problems or questions. The length of each call will be between 20-15 minutes. The researcher will talk about their issues and problems, and patients’ questions will be answered as well. The content of telephone conversations will be written based on the results of new researches and using scientific resources in the field of breast cancer and will be approved by the Department of Oncology in Kashan University of Medical Sciences. In addition, patients’ questions in specialized areas will be answered after consultation with an oncologist. The contacts time will be set based on patients’ willingness. A phone number will be provided by the researcher for the intervention group so they can get in touch with the researcher if they have any problems or questions during the weeks in determined hours every day (9 am to 12 noon and 4 pm to 9 pm). Intervention 2: Control group: The control group will only receive usual care.</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></results_IPD_plan>
      <results_IPD_description></results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Parisa Javadie</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Basij Sq, Payambar Azam University complex,  Blue wing, third floor, Arak</address>
        <city>Arak</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 86 4317 3524</telephone>
        <email>parisa.javadi.89@gmail.com</email>
        <affiliation>Arak Medical Sciences University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Nazi Nejat</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Basij Sq, Payambar Azam University complex, Blue wing, third floor, Arak</address>
        <city>Arak</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 86 3417 3501</telephone>
        <email>n.nejat@arakmu.ac.ir; nazinejat@gmail.com</email>
        <affiliation>Arak Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: Eligibility to participate was restricted to people diagnosed with cancer; aged between 18-80 years; aware of their diagnosis; are treathed for first round;  physically and mentally capable of participating in the study ( the ability to read and write and lack of hearing loss and speech problems), telephone access at home, and  living in Kashan. &#13;
 &#13;
Exclusion criteria:  The  the exclusion criteria are unwillingness to participate in the study and death</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>80 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>C50-C50</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Malignant neoplasm of breast</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Other</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Telephone intervention will be performed for a month. The first contact with participants will be done during a week after the first meeting. The researcher will call patients in the intervention group twice a week, and they can also get in touch with the researcher if they have any problems or questions. The length of each call will be between 20-15 minutes. The researcher will talk about their issues and problems, and patients’ questions will be answered as well. The content of telephone conversations will be written based on the results of new researches and using scientific resources in the field of breast cancer and will be approved by the Department of Oncology in Kashan University of Medical Sciences. In addition, patients’ questions in specialized areas will be answered after consultation with an oncologist. The contacts time will be set based on patients’ willingness. A phone number will be provided by the researcher for the intervention group so they can get in touch with the researcher if they have any problems or questions during the weeks in determined hours every day (9 am to 12 noon and 4 pm to 9 pm).</i_keyword>
      <i_keyword>Control group: The control group will only receive usual care.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Supportive care needs. Timepoint: Baseline, 2 weeks after the intervention, one month after intervention. Method of measurement: Supportive care needs survey short form 34(SCNS-SF34).</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Psychological needs. Timepoint: baseline, two weeks and one month after intervention. Method of measurement: Psychological dimension of SCNS-SF34.</sec_outcome>
      <sec_outcome>Health system &amp; information needs. Timepoint: baseline, two weeks and one month after intervention. Method of measurement: Health system &amp; information dimension of SCNS-SF34.</sec_outcome>
      <sec_outcome>Physical &amp; daily living. Timepoint: Baseline, two weeks and one month after intervention. Method of measurement: Physical &amp; daily living dimension of SCNS-SF34.</sec_outcome>
      <sec_outcome>Patient care &amp; support. Timepoint: Baseline, two weeks and one month after intervention. Method of measurement: Patient care &amp; support dimension of SCNS-SF34.</sec_outcome>
      <sec_outcome>Sexual needs. Timepoint: Baseline, two weeks and one month after intervention. Method of measurement: Sexual dimension of SCNS-SF34.</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>Vice Chancellor for Research ofArak University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2016-09-05</approval_date>
        <contact_name>Ethics committee of Arak University of Medical Sciences</contact_name>
        <contact_address>Basij Sq, Payambar Azam University complex,  Emam Mosa Kazem building, Arak arak  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
