<?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>IRCT20230129057271N5</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2025-12-12</date_registration>
      <primary_sponsor>Bagheiat-allah University of Medical Sciences</primary_sponsor>
      <public_title>Applying spiritual palliative care guidelines in patients with cancer</public_title>
      <acronym></acronym>
      <scientific_title>Investigating the effectiveness of spiritual palliative care guidelines in patients with cancer</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2025-12-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>44</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/87129</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Allocation of patients in two groups will be done in random blocks so that; The block size is equal to 4. The randomization tool in this research will be the use of four envelopes containing two sheets A and two sheets B, each time by removing one of the sheets, the patient will be placed in the intervention or control group. The removed sheets will not be returned to the envelope until the 4 sheets are finished. After determining the assignment of the first 4 patients, the sheets are returned to the envelope and the next 4 patients will continue in this way until the sample size is completed.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Condition 1: Colon cancer. Condition 2: Breast cancer. Condition 3: Prostate cancer.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: During this study, the intervention group included patients who would receive spiritual palliative care from a nurse. Spiritual palliative care instructions will be provided to them over 8 sessions (Titles: Introduction and exploration of meaning and values ​​- Connection with the higher self and the source of faith - Meditation through prayer and book therapy - Finding meaning in suffering and illness - Connection with others and a sense of belonging - Trust, hope, and patience in the face of limitations - Identity and its promotion and self-help practice - Conclusion and integration), and patients will be taught the relevant materials. These materials will be presented to patients in accordance with the titles mentioned and solely based on spiritual therapy and with the aim of spirituality in patients. In each session, the researcher will be present at the patient's bedside and in the inpatient ward for one hour and will teach or share relevant matters with the patient, and at the end of the session, the assignments related to the session will be handed over to the patient. During this study, each session will be held in a separate week.  This guideline was developed by the researchers involved in the study, and its face and content validity was reviewed by university faculty members. Intervention 2: Control group: In this study, the control group includes patients who will only receive routine nursing care and will not receive spiritual palliative 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>Undecided - It is not yet known if there will be a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for indecision in sharing IPD is I haven't decided yet - the release schedule is still unknown.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Seyed Morteza Hosseini</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Baqiyatallah University of Medical Sciences, South Sheikh Bahai, Mulla Sadra Street, Vanak Square, Tehran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>۱۴۳۵۹۱۶۴۷۱</zip>
        <telephone>+98 901 669 0780</telephone>
        <email>sm_hosseini@yahoo.com</email>
        <affiliation>Bagheiat-allah University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Seyed Morteza Hosseini</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Baqiyatallah University of Medical Sciences, South Sheikh Bahai, Mulla Sadra Street, Vanak Square, Tehran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>۱۴۳۵۹۱۶۴۷۱</zip>
        <telephone>+98 901 669 0780</telephone>
        <email>sm_hosseini@yahoo.com</email>
        <affiliation>Bagheiat-allah University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Age between 18 and 60 years old
Having sufficient literacy skills to complete the survey
Cancer diagnosis for at least 6 months
Lack of known mental illness
Willingness to voluntarily participate in the study
Failure to participate in other related educational programs
Lack of sensory impairments, such as vision or hearing problems, that affect learning
Having colon, breast, or prostate cancer</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>60 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Use of addictive substances
Having diseases other than cancer
Occurrence of a specific incident before the study</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>C18</hc_code>
      <hc_code>C50</hc_code>
      <hc_code>C61</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Malignant neoplasm of colon</hc_keyword>
      <hc_keyword>Malignant neoplasm of breast</hc_keyword>
      <hc_keyword>Malignant neoplasm of prostate</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Other</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: During this study, the intervention group included patients who would receive spiritual palliative care from a nurse. Spiritual palliative care instructions will be provided to them over 8 sessions (Titles: Introduction and exploration of meaning and values ​​- Connection with the higher self and the source of faith - Meditation through prayer and book therapy - Finding meaning in suffering and illness - Connection with others and a sense of belonging - Trust, hope, and patience in the face of limitations - Identity and its promotion and self-help practice - Conclusion and integration), and patients will be taught the relevant materials. These materials will be presented to patients in accordance with the titles mentioned and solely based on spiritual therapy and with the aim of spirituality in patients. In each session, the researcher will be present at the patient's bedside and in the inpatient ward for one hour and will teach or share relevant matters with the patient, and at the end of the session, the assignments related to the session will be handed over to the patient. During this study, each session will be held in a separate week.  This guideline was developed by the researchers involved in the study, and its face and content validity was reviewed by university faculty members.</i_keyword>
      <i_keyword>Control group: In this study, the control group includes patients who will only receive routine nursing care and will not receive spiritual palliative care.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Quality of life of patients. Timepoint: At the beginning of the study (before intervention) and after the last session of implementing spiritual palliative care guidelines. Method of measurement: Using the Missoula – VITAS quality of life index (MVQOLI).</prim_outcome>
      <prim_outcome>Patients' perceptions of the quality of palliative care. Timepoint: After the last session of implementing spiritual palliative care guidelines. Method of measurement: Using the patients' perspectives of the quality of palliative care questionnaire.</prim_outcome>
      <prim_outcome>Incidence of palliative care outcomes. Timepoint: After the last session of implementing spiritual palliative care guidelines. Method of measurement: Using the Palliative Care Outcome Scale (POS) 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>Bagheiat-allah University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2025-10-06</approval_date>
        <contact_name>Research Ethics Committees of Baqiyatallah Hospital</contact_name>
        <contact_address>Baqiyatallah University of Medical Sciences, South Sheikh Bahai, Mulla Sadra Street, Vanak Square, Tehran Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
