<?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>IRCT20190106042252N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-01-27</date_registration>
      <primary_sponsor>Fasa University of Medical Sciences</primary_sponsor>
      <public_title>The Effect of Palliative Care Based on Spirituality on Pain, Quality of Life and Nausea and Vomiting in Women with Colon Cancer</public_title>
      <acronym></acronym>
      <scientific_title>The Effect of Palliative Care Based on Spirituality on Pain, Quality of Life and Nausea and Vomiting in Women with Colon Cancer in Amir Shiraz Hospital</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-01-19</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>72</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/36563</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: In the sampling method, all available patients Enter the study.These patiens are assigned to the test and control group by Block randomization.
A: گروه کنترل
B: گروه آزمون

B(7)	A(5)	B(3)	A(1)
B(8)	A(6)	A(4)	B(2)
 Then we randomize by Using 9 blocks of 8 people, Blinding description: All participants are informed by informed consent and informed about the purpose of the study. However, they are not familiar with the control group or the test. Spirituality-based palliative care training sessions are held for the intervention group. In order to observe the intellectual property of the participants, the control group will be provided with a pediatric spirituality-based palliative care training package. All members are aware of the purpose of the study, and how they are done, but they are not informed about the two groups of control and test. So, the study is mono-blind, and researcher, clinical caregiver and data analyst are aware of the allocation of control and test groups. For Examples of mental health counselors, nutritionists, pain specialists, clerks, and final data analyst are known from the control and test team members, but participants do not know which groups will be included.</study_design>
      <phase>N/A</phase>
      <hc_freetext>colon cancer.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: First , after a course of chemotherapy ,questionnaires will distributed between 36 member of the intervention group .Then at the time of the referral of patients for the next chemotherapy course ,Training program begins for the exam group.The interval between chemotherapy courses is usually two weeks . And every patient needs ten to twelve weeks of chemotherapy , depending on the severity of the patient's disease and physician's discretion.The training program(The curriculum) consists of 7 sessions ,that each session takes an average of 1 hours. this curriculum includes the following:   Session One: playing verses from the Holy Quran. Second Session: playing prayer and group chants. Session 3: Spiritual and peer-based Support,Talking to Patients about communication with God, your self, Others and Nature.Session Four: Playing Religious video  Clips.Session 5: Spiritual Advice.Session Six: Nutrition Advice.Seventh Session: Mental Advice. After completing the training course and in the last session ,The questionnaires will be distributed immediately and after a month. Intervention 2: Control group: First, after completing a chemotherapy course, questionnaires are distributed among the control group members.Then, at the time of the referral of patients for the next chemotherapy course, these patients will receive only a series of educational pamphlets related to palliative care based on spirituality.</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 final data of the study is after statistical analysis and the results are comparable.
Access to questionnaires and informed consent form is not permitted.

When:
2 months after the final release of the results

To whom:
Researchers working in academic and scientific institutions and hospital staff

Conditions:
All clinics that are responsible for caring for patients with colon cancer can use this research to care for patients.
 It can also be used for other research on palliative care. The right to use the names of patients, the forms of consent to participate in the research.

Where to obtain:
Parisa sabet sarvestani- 09171898537-123ps74@gmail.com
Dr shahnaz karimi-09173310457-sh.karimi16@yahoo.com
Fasa University of Medical Sciences- research@fums.ac.ir

How to obtain:
Search the title of research on valid sites
calling the responsible person
Email to Fasa University of Medical Sciences

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Parisa Sabetsarvestani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No.599, emam khomeini street, 22 alley</address>
        <city>Sarvestan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7345187749</zip>
        <telephone>+98 71 3784 4396</telephone>
        <email>123ps74@gmail.com</email>
        <affiliation>Fasa University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Parisa Sabetsarvestani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No.599, emam khomeini street, 22 alley</address>
        <city>Sarvestan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7345187749</zip>
        <telephone>+98 71 3784 4396</telephone>
        <email>123ps74@gmail.com</email>
        <affiliation>Fasa University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Patients who are at stage 1 and 2 and 3 of their illness
Patients who are aware of their diagnosis
Patients who have at least one chemotherapy course
Patients at the minimum functional level
Age between 25 and 75 years
Complete mental health
Willingness to cooperate
Not suffering from other diseases except colon cancer
Having minimal spiritual beliefs
Lack of vision and hearing problems
Lack of experience using  palliative care base on spirituality</inclusion_criteria>
      <agemin>25 years</agemin>
      <agemax>75 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Lack of cooperation
Occurs a particular physical condition</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>C18.9</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Malignant neoplasm of colon, unspecified</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: First , after a course of chemotherapy ,questionnaires will distributed between 36 member of the intervention group .Then at the time of the referral of patients for the next chemotherapy course ,Training program begins for the exam group.The interval between chemotherapy courses is usually two weeks . And every patient needs ten to twelve weeks of chemotherapy , depending on the severity of the patient's disease and physician's discretion.The training program(The curriculum) consists of 7 sessions ,that each session takes an average of 1 hours. this curriculum includes the following:   Session One: playing verses from the Holy Quran. Second Session: playing prayer and group chants. Session 3: Spiritual and peer-based Support,Talking to Patients about communication with God, your self, Others and Nature.Session Four: Playing Religious video  Clips.Session 5: Spiritual Advice.Session Six: Nutrition Advice.Seventh Session: Mental Advice. After completing the training course and in the last session ,The questionnaires will be distributed immediately and after a month.</i_keyword>
      <i_keyword>Control group: First, after completing a chemotherapy course, questionnaires are distributed among the control group members.Then, at the time of the referral of patients for the next chemotherapy course, these patients will receive only a series of educational pamphlets related to palliative care based on spirituality.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pain score in Short Pain Questionnaire(BPI). Timepoint: Measuring the pain before and after intervention and one month after the intervention. Method of measurement: Short Pain Questionnaire (Brief Pain Inventory).</prim_outcome>
      <prim_outcome>Quality of Life Score in World Health Organization Quality of Life Questionnaire. Timepoint: Measuring the quality of Life before and after intervention and one month after the intervention. Method of measurement: World Health Organization Quality of Life Questionnaire((WHOQOL-BREF).</prim_outcome>
      <prim_outcome>Nausea and vomiting score in the questionnaire for measurement of nausea and vomiting, Korn et al. Timepoint: Measuring the nausea and vomiting before and after intervention and one month after the intervention. Method of measurement: Questionnaire for measurement of nausea and vomiting by Korn et al (PUQE).</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>Fasa University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2018-11-11</approval_date>
        <contact_name>Ethics committee of Fasa University of Medical Sciences</contact_name>
        <contact_address>Ebnesina square Fasa Fars Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
