<?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>IRCT2017022327728N5</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2017-05-13</date_registration>
      <primary_sponsor>Alborz University of Medical Sciences</primary_sponsor>
      <public_title>The effectiveness of health literacy group consultation on selfcare in women with breast cancer</public_title>
      <acronym></acronym>
      <scientific_title>The effectiveness of health literacy group consultation on self care in women with breast cancer</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2017-04-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>32</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/22653</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Breast cancer.</hc_freetext>
      <i_freetext>Intervention 1: 1-Intervention group: In this group addition to routine counseling, Consultation with health literacy approach in self-care will offer in sessions. The number of sessions 7  and the duration of each sessions is an hour and a half the content that will be presented in each session is : session I: meet  members and leaders of groups, create positive relationships،Expression rules of the group and motivate active participation and time attendance at meetings ،a description of the nature of the disease and chemotherapy, feeling of sickness،Perceptions of the disease affect the body, and the importance of self-care needs of patients in their care. Session 2: Advice on health related concepts, understand basic information and familiarity with the person's thinking in the field of health care, digestive problems and ways of dealing with it. Session 3:  Understand basic information and familiarity with the person's thinking in the field of skin and hair health, ways of dealing with it. Session 4: understand basic information and a familiar with the person's thinking in the field of   fatigue, shortness of breath, pain, sexual problems and the proposed solutions to reduce complications. Session 5: Meeting the basic knowledge and a familiar with the person's thinking In the field of Mental   Health (stress, depression) ،symptoms and consequences، the need to identify, Prevention ways and ways of dealing with it Understanding concepts related to communication skills, understand the impact of family and social support. Session 6: understand basic information and a familiar with the person's thinking in the field of complications of treatments, the need to identify, prevent ways and the ways of dealing with it, and familiarity with the service provider associated with breast cancer. Session 7: Summary of presentations, training in counseling skills, ask questions about the classes held .receive feedback. Intervention 2: 2-Control group: In this group routine counseling sessions and self-care training package offered to control group.</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>Dr Zohreh Mahmoodi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Department of Nursing and midwifery Alborz University of Medical Sciences, Eshteraki Street, Baghestan, Karaj, Iran</address>
        <city>Karaj</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 26 3430 4433</telephone>
        <email>zohrehmahmoodi2011@gmai.com; zohrehmahmoodi.abzums.ac.ir</email>
        <affiliation>Alborz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr Zohreh Mahmoodi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Department of Nursing and Midwifery  of Alborz University of Medical Sciences, Eshteraki Street, Baghestan, Karaj, Iran</address>
        <city>Karaj</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 26 3430 4433</telephone>
        <email>zohrehmahmoodi 2011@gmail.com ;zohrehmahmoodi.abzums.ac.ir</email>
        <affiliation>Alborz University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: Iranian women; women with breast cancer who have had a mastectomy; the first meeting of chemotherapy; no other underlying disease; wanting to take part in the study.&#13;
Exclusion criteria: no wanting to take part in the study; lack of participation in a maximum of two sessions of consultations; failure to complete or partially completed questionnaires.</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</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>Prevention</i_code>
      <i_code>Prevention</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>1-Intervention group: In this group addition to routine counseling, Consultation with health literacy approach in self-care will offer in sessions. The number of sessions 7  and the duration of each sessions is an hour and a half the content that will be presented in each session is : session I: meet  members and leaders of groups, create positive relationships،Expression rules of the group and motivate active participation and time attendance at meetings ،a description of the nature of the disease and chemotherapy, feeling of sickness،Perceptions of the disease affect the body, and the importance of self-care needs of patients in their care. Session 2: Advice on health related concepts, understand basic information and familiarity with the person's thinking in the field of health care, digestive problems and ways of dealing with it. Session 3:  Understand basic information and familiarity with the person's thinking in the field of skin and hair health, ways of dealing with it. Session 4: understand basic information and a familiar with the person's thinking in the field of   fatigue, shortness of breath, pain, sexual problems and the proposed solutions to reduce complications. Session 5: Meeting the basic knowledge and a familiar with the person's thinking In the field of Mental   Health (stress, depression) ،symptoms and consequences، the need to identify, Prevention ways and ways of dealing with it Understanding concepts related to communication skills, understand the impact of family and social support. Session 6: understand basic information and a familiar with the person's thinking in the field of complications of treatments, the need to identify, prevent ways and the ways of dealing with it, and familiarity with the service provider associated with breast cancer. Session 7: Summary of presentations, training in counseling skills, ask questions about the classes held .receive feedback.</i_keyword>
      <i_keyword>2-Control group: In this group routine counseling sessions and self-care training package offered to control group.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Health  literacy. Timepoint: At the beginning of the first session, at the end of sessions, three weeks after the intervention. Method of measurement: Iranian Health literacy  Inventory.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Selfcare. Timepoint: At the beginning of the first session, at the end of sessions, three weeks after the intervention. Method of measurement: self care  Inventory.</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>Alborz University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2017-01-28</approval_date>
        <contact_name>Alborz University Of Medical Sciences.</contact_name>
        <contact_address>ninth floor, Dara building, north Yasmin, east Pune street, 45 Yards of Golshahr, karaj, Iran. karaj  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
