<?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>IRCT20190715044212N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-11-12</date_registration>
      <primary_sponsor>Islamic Azad University</primary_sponsor>
      <public_title>Comparison of the Effectiveness of Spiritual Therapy and Mindfulness Education on Quality of Life, Life expectancy and resilience in breast cancerous patients</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of the Effectiveness of Spiritual Therapy and Mindfulness Education on Quality of Life, Life expectancy and resilience in breast cancerous patients</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-11-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>30</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/40813</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Other design features: model-based, Randomization description: The name of the people with consent form were written on the similar papers and folded, mixed  and put into a container, then we asked one person outside the study group to pull each paper out of the container in a row with closed eyes and assign them in two groups A or B.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Breast Cancer.</hc_freetext>
      <i_freetext>Intervention 1: The first Intervention group: The interventions were made in both groups. A quasi-experimental crossover design method was used. To this end, a pre-test design, including the quality of life, life expectancy, and resilience questionnaires, was initially implemented for all the subjects. The subjects were then matched based on age, education level, and the degree of disease who were randomly assigned to two groups of A and B. The spiritual therapy interventions’ plan was implemented for group A, while group B received the mindfulness training. A post-test of the three mentioned scales (quality of life, life expectancy, and resilience) was implemented for both groups three days after the end of all interventions for both test groups. Intervention 2: The second Intervention group: The interventions were changed for the groups after one week; i.e., group B received the spiritual therapy training and mindfulness training was implemented for group A. The post-test design was conducted for both groups three days after the end of the training course. Finally, the results of the mean values of each group, and each individual were evaluated and compared with themselves. The findings were also analyzed using SPSS software, Ver. 23.</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 privacy policy</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Seyyed Abdul Majid Bahraini</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Hemmat highway next to Milad Tower</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>14256325</zip>
        <telephone>0098218825685</telephone>
        <email>majid-bahrainian36@yahoo.com</email>
        <affiliation>Iran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Minoo Assadzandi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Baqiyatallah Hospital,Mallak Sadra Street Vanak Square</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>585896655</zip>
        <telephone>+98 21 8805 0435</telephone>
        <email>zandi498@yahoo.com</email>
        <affiliation>Bagheiat-allah University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Breast Cancer Disease
Diploma and higher education
Degree of disease between level 1 to 3
Being able to communicate and understand the lessons
Familiarity with Persian language</inclusion_criteria>
      <agemin>35 years</agemin>
      <agemax>no limit</agemax>
      <gender>Female</gender>
      <exclusion_criteria>History of  mental illness in the past or present
history of taking psychiatric drugs
Taking psychotropic drugs or a history of drug addiction
Having another illness, or complications that may result in hospitalization in ICU
Unwilling to continue research during the study
Simultaneous participation in other research
The occurrence of a major life crisis in addition to the illness crisis during the study</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>Behavior</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>The first Intervention group: The interventions were made in both groups. A quasi-experimental crossover design method was used. To this end, a pre-test design, including the quality of life, life expectancy, and resilience questionnaires, was initially implemented for all the subjects. The subjects were then matched based on age, education level, and the degree of disease who were randomly assigned to two groups of A and B. The spiritual therapy interventions’ plan was implemented for group A, while group B received the mindfulness training. A post-test of the three mentioned scales (quality of life, life expectancy, and resilience) was implemented for both groups three days after the end of all interventions for both test groups.</i_keyword>
      <i_keyword>The second Intervention group: The interventions were changed for the groups after one week; i.e., group B received the spiritual therapy training and mindfulness training was implemented for group A. The post-test design was conducted for both groups three days after the end of the training course. Finally, the results of the mean values of each group, and each individual were evaluated and compared with themselves. The findings were also analyzed using SPSS software, Ver. 23.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Quality of Life: The World Health Organization (2000) defines the concept of quality of life in terms of people's understanding of their life situation in terms of their culture, the value system they live in, their goals, expectations, standards and priorities (Karimloo et al., 2010). Timepoint: Pre-test and Post-test. Method of measurement: Quality of Life Questionnaire.</prim_outcome>
      <prim_outcome>Life expectancy: Life expectancy is a mental set that is based on a mutual sense of will and planning to achieve a goal (Schneider et al., 2006). Timepoint: Pre-test and Post-test. Method of measurement: Hope Questionnaire.</prim_outcome>
      <prim_outcome>Resilience: In the Merriam-Webster culture, resilience is called the ability to recover after difficult conditions or to adapt to those conditions. In other words, resiliency is one of the behavioral traits of individuals who are exposed to certain risk factors and can overcome the risks and avoid negative consequences such as delinquency and behavioral problems (Massen, 1999). Timepoint: Pre-test and Post-test. Method of measurement: Conner and Davidson's Resiliency Questionnaire.</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>فردی</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-10-16</approval_date>
        <contact_name>Ethics in Research of Islamic Azad University Science and Research Branch</contact_name>
        <contact_address>University of Science and Research , End of Sattari Highway Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
