<?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>IRCT20190508043520N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-09-02</date_registration>
      <primary_sponsor>Boushehr University of Medical Sciences</primary_sponsor>
      <public_title>The effectivness of Group Spiritual Therapy on Health Status ,Coping strategies &amp; SerumT Lymphocyt Immune System in Women With Breast Cancer.</public_title>
      <acronym></acronym>
      <scientific_title>The effectivness of Group Spiritual Therapy on Health Status ,Coping strategies &amp; SerumT Lymphocyt Immune System in Women With Breast Cancer.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-05-11</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/39375</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Other, Purpose: Supportive, Other design features: This was a quasi-experimental study, procedure by a pre-, post-test approach with case control groups and the subjects were selected with the specifies  criteria and replaced in two groups of the case (30 patients) and control (30 patients)..60 patients with breast cancer refer  for treatment to Shafa Clinic in Bushehr were selected and randomly divided into experimental and control group. ,then ,only  the experimental group underwent twelve 90 minute sessions  of spirituality therapy intervention and control group  would be received the usual medical care.the specifies  criteria :.Age  between 30 to 59years  ;being at clinical stage  I , II , or III ;no metastatic lesion ;at least 8 months after diagnosis and termination of acute treatment period such as surgery, chemotherapy, and radiation therapy , having literacy ; no history of psychotropic drug used,  and no history of alcohol or smoked used during the 3 months before the study,  no history of other neurosis or psychosis before diagnosis like DSM-V,such as depression and schizophrenia, having  letter of satisfaction ,no history of other cancer during 10 years, no history of other chronic diseases ;and no history of psycho- spiritual education , Randomization description: This was a quasi-experimental study, procedure by a pre-post-test approach with case control groups and the subjects were selected and replaced in two groups of the case (30 patients) and control (30 patients )with the specifies  criteria . Randomize Allocation ,The Permuted block randomization method in clinical trial designed to randomize subjects into groups that result in equal sample sizes. Randomization ensures that each patient has an equal chance to settle in each groups (experimental  or  control groups).
Sixty breast cancer women (30 to 59 years)  refer for treatment to Shafa Clinic in Bushehr selected and placed in two groups(case-control),then the experimental group underwent twelve 90 minute sessions  of spirituality therapy intervention.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Breast cancer.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group:  experimental group : The 30 breast cancer  patients(30 to 59 years)  refer for treatment to SHafa Clinic in Bushehr  in the experimental group underwent twelve   weekly 90 minute sessions  of spirituality therapy intervention.The purpose of spirituality therapy؛  additional awareness ,Coping &amp;  problem solving ,assurance,self regulation,buoyancy,review the  purposeful  and meaningful life.                                                                                                                                    session 1: acquaint to another &amp; explanation  experience of spirituality. session 2: introspection .                                                                                  session 3: recognition the source of fear &amp; anxiety ,distress  and   own strategies for coping with  them.                                                                                      session 4: understand  the concept  of dateless &amp; unending concept .                                                                                                 session 5:  understand the concept  of rancor &amp; devotion.                session 6:  understand the concept  of  meditation &amp;  compute .                                                                           session 7:  meditation &amp; relaxation .                                                                                                                   session  8: understand the concept of remission and solving conflict  &amp; anger.                                                                                                                                session  9:  remission and solving conflict &amp; anger focus on self,others &amp; world.                                                                                                         session 10:  enhanced  self regulating.                                                                                                       session 11:self care in  alarm protection ,hope,self expectation, acceptance ,patience and  move responsible.                                     session 12: to look together,settle self monitoring &amp; self controlling and end of session. Intervention 2: Control group: The control group (C) was asked to stay for a period of 3 months on the waiting list and  would be recived  the usual care from  their doctor on treatment plan. after end of session. intervention , a 4 hour psycho- education meeting   concerning readjustment with  cancer were executed  for control group in one day.</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:
The part of information related to consequences variables

When:
6 month afert edition the results

To whom:
The researchers of  academic &amp;  scientific center

Conditions:
for another researches

Where to obtain:
hossaini@outlook.com

How to obtain:
If you have more information  contact  email hossaini@outlook.com

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Zinab Hoossaini</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Moalem Avn, Bushehr Province University Of Medical Science-manager area-layer 2</address>
        <city>Bushehr</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7514633341</zip>
        <telephone>00987733329198-00987733323121</telephone>
        <email>hossaini@outlook.com</email>
        <affiliation>Boushehr University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Zinab</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Moalem Avn, Bushehr Province University Of Medical Science-manager area-layer 2</address>
        <city>Bushehr</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7514633341</zip>
        <telephone>+98 77 3332 9198</telephone>
        <email>hossaini@outlook.com</email>
        <affiliation>Boushehr University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>breast cancer diagnosis from oncologist.
being at clinical stage  I , II , or III
no metastatic lesion.
Age  between 30 to 59 years
ََAt least 8 months after diagnosis and termination of acute treatment period such as surgery, chemotherapy, and radiation therapy which are effective in psycho-spiritual aspect and may have caused some bias in the study.
having literacy
having  letter of satisfaction
no history of psychotropic drug use, and no history of alcohol used or smoked during the 3 months before the study.
no history of other neurosis or psychosis before diagnosis  , such as depression and schizophrenia..
no history of other chronic diseases.
no history of other cancer during 10 years.
no history of psycho- spiritual education .</inclusion_criteria>
      <agemin>30 years</agemin>
      <agemax>59 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>dissatisfaction  to participate in research
any disability to be present in sessions intervention
those with history of  cognitive disorder,confusion or  cerebral injury.</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>Intervention group:  experimental group : The 30 breast cancer  patients(30 to 59 years)  refer for treatment to SHafa Clinic in Bushehr  in the experimental group underwent twelve   weekly 90 minute sessions  of spirituality therapy intervention.The purpose of spirituality therapy؛  additional awareness ,Coping &amp;  problem solving ,assurance,self regulation,buoyancy,review the  purposeful  and meaningful life.                                                                                                                                    session 1: acquaint to another &amp; explanation  experience of spirituality. session 2: introspection .                                                                                  session 3: recognition the source of fear &amp; anxiety ,distress  and   own strategies for coping with  them.                                                                                      session 4: understand  the concept  of dateless &amp; unending concept .                                                                                                 session 5:  understand the concept  of rancor &amp; devotion.                session 6:  understand the concept  of  meditation &amp;  compute .                                                                           session 7:  meditation &amp; relaxation .                                                                                                                   session  8: understand the concept of remission and solving conflict  &amp; anger.                                                                                                                                session  9:  remission and solving conflict &amp; anger focus on self,others &amp; world.                                                                                                         session 10:  enhanced  self regulating.                                                                                                       session 11:self care in  alarm protection ,hope,self expectation, acceptance ,patience and  move responsible.                                     session 12: to look together,settle self monitoring &amp; self controlling and end of session.</i_keyword>
      <i_keyword>Control group: The control group (C) was asked to stay for a period of 3 months on the waiting list and  would be recived  the usual care from  their doctor on treatment plan. after end of session. intervention , a 4 hour psycho- education meeting   concerning readjustment with  cancer were executed  for control group in one day..</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Health Status. Timepoint: Study of  Health Status at the beginning  ,before  intervention and after 12 weekly  session(  3 month after  Intervention) . Method of measurement: WHO Individual Questionnaire 2016.</prim_outcome>
      <prim_outcome>Coping strategies. Timepoint: Study of  Coping strategies  at the beginning  ,before  intervention and after 12 weekly  session(  3 month after  Intervention) . Method of measurement: Lazarus &amp; Folkman  coping strategy questionnaire 1988.</prim_outcome>
      <prim_outcome>Serum T Lymphocyte  Immune System. Timepoint: Measure Serum  T Lymphocyte  Immune System  at the beginning  ,before  intervention and after 12 weekly  session(  3 month after  Intervention). Method of measurement: 5 cc blood was obtained from participants  &amp; test analyzed  by  flow  cytometry.</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>Boushehr University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-04-22</approval_date>
        <contact_name>National Medical Ethics Commitee</contact_name>
        <contact_address>Moalem Avn -Bushehr province university of medical science Bushehr Boushehr Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
