<?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>IRCT20230408057845N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-10-13</date_registration>
      <primary_sponsor>Shahid Beheshti University of Medical Sciences</primary_sponsor>
      <public_title>The effect of spiritual care on resilience and self-efficacy of patients with cancer</public_title>
      <acronym></acronym>
      <scientific_title>The effect of spiritual care on resilience and self-efficacy of patients with cancer referred to oncology ward of shahid beheshti related hospitals</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-11-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>100</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/70265</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Factorial, Purpose: Education/Guidance, Randomization description: The initial sampling will be based on the available method and the main sampling of the present study will be in the form of block randomization. Patients who meet the inclusion criteria were randomly divided into two groups, the intervention group and the control group. Sealed Envelope Ltd 2019 online randomization service was used to generate the randomization list.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Condition 1: Cancer. Condition 2: Cancer. Condition 3: Cancer.</hc_freetext>
      <i_freetext>Intervention 1: The intervention in the present study for the people of the intervention group will include providing spiritual care, derived from the spiritual-religious strategies of Richards and Bergin, who will receive 6 sessions in groups of 10 people 2 days a week (4 days apart) for 3 weeks. The duration of the intervention is 15-20 minutes, and the topics of spiritual care will be in the form of a face-to-face conversation and the presentation of a pamphlet containing the topics presented in the sessions. The sessions will include counseling, lectures, PowerPoint presentations, questions and answers, and group discussions, expressing experiences related to the topic and contents of the session between the researcher, patients, and their home caregivers. The phone and SMS system will be available to the participants during the study period to solve their questions and concerns. After the intervention, resilience and self-efficacy questionnaires will be completed by patients in both intervention and control groups. Intervention 2: The group in which no intervention is used, so the level of resilience and self-efficacy of the participants will be evaluated at the beginning and three weeks later. Participants in this group will not receive any palliative care program. Like the participants in the intervention group, these patients will follow all the doctor's prescriptions and usual care such as taking anti-nausea drugs, corticosteroids, benzodiazepines and other drugs according to the doctor's request.</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:
Data related to demographic questionnaires and Connor and Davidson Resilience Questionnaire (CD-RISC) and General Self-Efficacy Scale (GSE-10) are presented as a summary, separately and in a file.

When:
The access period starts 6 months after the results are published.

To whom:
Clients, advisors, guides and all researchers

Conditions:
General researchers are allowed to use any type of analysis.

Where to obtain:
To receive documents, send to shivabayat0@gmail.com.

How to obtain:
Send to the recipient's email address.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Shiva Bayat</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 286, Rodbari St., Dardasht St., Narmak</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1649848565</zip>
        <telephone>+98 21 7792 5821</telephone>
        <email>shivabayat0@gmail.com</email>
        <affiliation>Shahid Beheshti University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Shiva Bayat</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 286, Rodbari St., Dardasht St., Narmak</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1649848565</zip>
        <telephone>+98 21 7792 5821</telephone>
        <email>shivabayat0@gmail.com</email>
        <affiliation>Shahid Beheshti University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Patients diagnosed with cancer must be confirmed by a specialist doctor.
Having full consciousness
Getting to know the Persian language</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Having visual impairment
Having hearing impairment
Having an active mental illness
Treatment with sedatives</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>C18</hc_code>
      <hc_code>C17</hc_code>
      <hc_code>D29.1</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Malignant neoplasm of colon</hc_keyword>
      <hc_keyword>Malignant neoplasm of small intestine</hc_keyword>
      <hc_keyword>Benign neoplasm of prostate</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Lifestyle</i_code>
      <i_code>Lifestyle</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>The intervention in the present study for the people of the intervention group will include providing spiritual care, derived from the spiritual-religious strategies of Richards and Bergin, who will receive 6 sessions in groups of 10 people 2 days a week (4 days apart) for 3 weeks. The duration of the intervention is 15-20 minutes, and the topics of spiritual care will be in the form of a face-to-face conversation and the presentation of a pamphlet containing the topics presented in the sessions. The sessions will include counseling, lectures, PowerPoint presentations, questions and answers, and group discussions, expressing experiences related to the topic and contents of the session between the researcher, patients, and their home caregivers. The phone and SMS system will be available to the participants during the study period to solve their questions and concerns. After the intervention, resilience and self-efficacy questionnaires will be completed by patients in both intervention and control groups.</i_keyword>
      <i_keyword>The group in which no intervention is used, so the level of resilience and self-efficacy of the participants will be evaluated at the beginning and three weeks later. Participants in this group will not receive any palliative care program. Like the participants in the intervention group, these patients will follow all the doctor's prescriptions and usual care such as taking anti-nausea drugs, corticosteroids, benzodiazepines and other drugs according to the doctor's request.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Resilience. Timepoint: 2 and 4 weeks after the intervention. Method of measurement: Connor and Davidson Resilience Questionnaire (CD-RISC).</prim_outcome>
      <prim_outcome>Self-efficacy. Timepoint: 2 and 4 weeks after the intervention. Method of measurement: General Self-Efficacy Scale (GSE-10).</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>Shahid Beheshti University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-09-10</approval_date>
        <contact_name>Ethics Committee of Shahid Beheshti University of Medical Sciences</contact_name>
        <contact_address>No. 286, Rodbari St., Dardasht St., Narmak Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
