<?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>IRCT20180721040540N5</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-06-07</date_registration>
      <primary_sponsor>Khoram-Abad University of Medical Sciences</primary_sponsor>
      <public_title>The effectiveness of community-based supportive palliative interventions</public_title>
      <acronym></acronym>
      <scientific_title>The effect of community-based palliative support interventions on the palliative outcomes of patients with advanced cancer and the quality of life of their family caregivers</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-04-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/68288</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: According to the provided list of qualified people from health centers, using a table of random numbers, moving from top to bottom even codes for the control group and odd codes for the intervention group as an example in are considered and this work continues until reaching the sample size for two groups.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Condition 1: Quality of Life. Condition 2: Supportive treatment. Condition 3: cancer.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group:the method of interventions in the intervention group will be as follows; When the doctor puts the cancer patient on palliative treatment, a meeting will be held with the presence of the family members in the presence of the student and caregiver working in the comprehensive health service center, and the consent and cooperation of the family to cooperate and receive palliative services from The channel of comprehensive health service centers will be acquired. The questionnaires will be provided to the research samples (patients and family caregivers) and they will be given the opportunity to complete them in a self-reported form. Then the student will explain the patient care plan and how to access services during the illness to the patient and family and encourage the patient and family to continue caring for the patient at home if the patient's condition is stable. In this meeting, the student will explain to the patient and family based on the type of cancer, the prognosis of the disease, the needs of the patient, the care that should be provided for him, as well as the structure of comprehensive health service centers, the capacities and how to access these services. The student will provide necessary training on how to provide care and also adapt the care environment to the patient and family at home. During the first week after the introduction, if the patient's condition is favorable, the patient and his main caregiver are invited to the comprehensive health center where the patient's family is a member, and the patient and the family meet with the team members, including doctors, psychologists, nurses, and nutritionists. They will get to know each other. In this meeting, the patient's case will be examined by the doctor and necessary information will be collected from the patient and the family. Also, the necessary information will be collected by other experts and necessary training will be given to the patient and family. Two weeks after the introduction, the nurse will visit the patient's home again through comprehensive health service bases and provide the necessary interventions and training to the patient and the patient's family based on the patient's condition and care needs. Home visit once every two weeks (of course, depending on the patient's condition) will be done through the comprehensive health service database channel, for two months from the time the patient entered the study. From the beginning of the palliative treatment, the patient and the family will be able to communicate with the nurse through the WhatsApp social messenger as well as the phone and get answers to their questions from the health staff. In the numerous meetings held with the presence of the patient and his family, things such as the diagnosis of patients' care needs, the nature of cancer, chemotherapy, radiotherapy and the importance of self-care will be discussed. Also, it will be discussed about digestive complications, problems related to skin, hair, fatigue, shortness of breath, pain, diarrhea, and vomiting, and proposed solutions to reduce and control these complications, as well as ways to improve the patient's adaptation in the field of social, family, and psychological issues. . A training booklet on how to care for the patient will be provided to the intervention group. In fact, the research starts from the specialized centers in the clinic accompanied by a specialist and continues to the people's homes, then it continues through the comprehensive health centers of the patient's place of residence. In addition to the educational and care services provided to the patient, the potential of other people present in the centers such as doctors, psychologists and nutritionists will also be used. At the end of two months and also 4-6 weeks after the completion of the interventions (to evaluate the sustainability of the interventions), the questionnaires will be provided to the test group, and again the QOLLTI-F family quality of life questionnaires of cancer patients and palliative care outcomes in adults with Cancer POS will be completed. Intervention 2: Control group: During the research period, the control group received their usual care from health service providers and no intervention will be done for them by the research team.</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 thesis report and questionnaires are shared

When:
After registering the thesis and publishing the articles related to the project

To whom:
The research team, the university's research officials, the supervisors' plan, the editors of specialized journals of researchers in the field of medical sciences

Conditions:
Conducting research to improve the quality of life of cancer patients and their families

Where to obtain:
Responsible researcher

How to obtain:
Coordinating with the researcher via e-mail, referring to the library of the Nursing Faculty of Lorestan University of Medical Sciences

Comments:
Special cases are not considered</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Heshmatullah Heydari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>5 km of Khorram Abad-Boroujerd road</address>
        <city>Khorramabad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>68149-93165</zip>
        <telephone>0174 3312 66 98 +</telephone>
        <email>Hidari74@gmail.com</email>
        <affiliation>Khoram-Abad University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Heshmatullah Heydari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>5 km of Khorram Abad-Boroujerd road</address>
        <city>Khorramabad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>68149-93165</zip>
        <telephone>+98 66 1233 0174</telephone>
        <email>hidari74@gmail.com</email>
        <affiliation>Khoram-Abad University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Willingness to participate in the study
Having advanced cancer
Having health records in comprehensive health centers
Age range between 20 and 75 years
Estimating the minimum survival of six months for the patient (due to cancer)
The inclusion criteria of the patient's main family caregiver included a willingness to participate in the study
A person who cares for patients on a daily basis but is not paid for the care they provide</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>75 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Participation in similar training courses
Lack of consciousness of time and place
The patient can't attend the training sessions
Known diseases</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code></hc_code>
      <hc_code>Z51.5</hc_code>
      <hc_code></hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword></hc_keyword>
      <hc_keyword>Encounter for palliative care</hc_keyword>
      <hc_keyword></hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Lifestyle</i_code>
      <i_code>Lifestyle</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group:the method of interventions in the intervention group will be as follows; When the doctor puts the cancer patient on palliative treatment, a meeting will be held with the presence of the family members in the presence of the student and caregiver working in the comprehensive health service center, and the consent and cooperation of the family to cooperate and receive palliative services from The channel of comprehensive health service centers will be acquired. The questionnaires will be provided to the research samples (patients and family caregivers) and they will be given the opportunity to complete them in a self-reported form. Then the student will explain the patient care plan and how to access services during the illness to the patient and family and encourage the patient and family to continue caring for the patient at home if the patient's condition is stable. In this meeting, the student will explain to the patient and family based on the type of cancer, the prognosis of the disease, the needs of the patient, the care that should be provided for him, as well as the structure of comprehensive health service centers, the capacities and how to access these services. The student will provide necessary training on how to provide care and also adapt the care environment to the patient and family at home. During the first week after the introduction, if the patient's condition is favorable, the patient and his main caregiver are invited to the comprehensive health center where the patient's family is a member, and the patient and the family meet with the team members, including doctors, psychologists, nurses, and nutritionists. They will get to know each other. In this meeting, the patient's case will be examined by the doctor and necessary information will be collected from the patient and the family. Also, the necessary information will be collected by other experts and necessary training will be given to the patient and family. Two weeks after the introduction, the nurse will visit the patient's home again through comprehensive health service bases and provide the necessary interventions and training to the patient and the patient's family based on the patient's condition and care needs. Home visit once every two weeks (of course, depending on the patient's condition) will be done through the comprehensive health service database channel, for two months from the time the patient entered the study. From the beginning of the palliative treatment, the patient and the family will be able to communicate with the nurse through the WhatsApp social messenger as well as the phone and get answers to their questions from the health staff. In the numerous meetings held with the presence of the patient and his family, things such as the diagnosis of patients' care needs, the nature of cancer, chemotherapy, radiotherapy and the importance of self-care will be discussed. Also, it will be discussed about digestive complications, problems related to skin, hair, fatigue, shortness of breath, pain, diarrhea, and vomiting, and proposed solutions to reduce and control these complications, as well as ways to improve the patient's adaptation in the field of social, family, and psychological issues. . A training booklet on how to care for the patient will be provided to the intervention group. In fact, the research starts from the specialized centers in the clinic accompanied by a specialist and continues to the people's homes, then it continues through the comprehensive health centers of the patient's place of residence. In addition to the educational and care services provided to the patient, the potential of other people present in the centers such as doctors, psychologists and nutritionists will also be used. At the end of two months and also 4-6 weeks after the completion of the interventions (to evaluate the sustainability of the interventions), the questionnaires will be provided to the test group, and again the QOLLTI-F family quality of life questionnaires of cancer patients and palliative care outcomes in adults with Cancer POS will be completed.</i_keyword>
      <i_keyword>Control group: During the research period, the control group received their usual care from health service providers and no intervention will be done for them by the research team.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Quality of Life. Timepoint: 2 months, a week before, a month after. Method of measurement: The score obtained from the QOLLTI-F questionnaire.</prim_outcome>
      <prim_outcome>Palliative care. Timepoint: 2 months, a week before, a month after. Method of measurement: The score obtained from the 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>Khoram-Abad University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-01-23</approval_date>
        <contact_name>Ethics Committee of Lorestan University of Medical Sciences</contact_name>
        <contact_address>Lorestan University of Medical Sciences, Kamalvand Road, Khorramabad, Borujerd, km 5 Khorramabad Lorestan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
