<?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>IRCT20240813062741N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2024-09-05</date_registration>
      <primary_sponsor>Tehran University of Medical Sciences</primary_sponsor>
      <public_title>The Effect of family-oriented dignity therapy on depression and spiritual well-being of patients and families of cancer patients.</public_title>
      <acronym></acronym>
      <scientific_title>The Effect of family-oriented dignity therapy on depression and spiritual well-being of patients and families of cancer patients.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2024-09-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>66</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/78727</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: The samples of this study will be among the cancer patients who meet the inclusion criteria, referring to selected hospitals affiliated to Tehran University of Medical Sciences, along with active family members as caregivers who meet the inclusion criteria, using available sampling method. became. Then, the sample members will be divided into two control and intervention groups by random block allocation method with blocks of 4. For this purpose, blocks of 4 will be selected, so that the letter A will be assigned to the intervention group and the letter B will be assigned to the control group. Six possible states will be written on separate cards and each card will be assigned a number from one to six, which will be as follows:
1) "AABB"
2) "ABBA"
3) "ABAB"
4) "BBAA"
5) "BAAB"
6) "BABA"
Then the numbers will be written on paper and poured into a container, and then a number from one to six will be randomly drawn until the expected number of samples is completed (the number of each number in the envelope in the package will be and the researcher is not aware of the numbers) and every time the numbers are returned to the container. In fact, 15 numbers will be randomly drawn from the container and the sequence of observed numbers will show the sequence of blocks.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Cancer.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group:  3 demographic questionnaires, Beck depression questionnaire and spiritual well-being questionnaire will be used for this study; Before the intervention, the questionnaires will be given to the intervention and control groups, and after completing the questionnaires, the family-oriented dignity therapy protocol will be implemented in the intervention group. In order to carry out the dignity therapy method, three sessions of 30-60 minutes will be considered for 3 weeks. In the first session, the researcher, while introducing the goals of the research, familiarized the participant with the questions of the family-oriented  dignity therapy protocol and provided the necessary opportunity to think about their statements in the next interview session. In the second session, which is 2 to 3 days after The basic meeting will be held, the researcher will guide the client during the interview with the patient-family couple and using the guiding questions of the family-oriented dignity therapy protocol to talk about the patient's life experiences in the context of the family. The participant's statements will be recorded during the interview while obtaining his permission. Then the recorded interviews are transcribed and edited (the questions are focused on eliciting the patients' life experiences in relation to their families, while the caregivers' answers are used to enrich the patients' narratives). In the third session, which is usually held 3 days after the third session, the therapist invites the patient and his family and provides them with the final version of the text to share with them. After the family-centered dignity therapy interventions, the questionnaires will be provided to the intervention and control groups again. Intervention 2: Control group: 3 demographic questionnaires, Beck's depression and spiritual well-being questionnaires will be provided to the patients before the intervention and 10 days after the intervention. At this time, only routine treatments are performed for the intervention group.</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:
Non-identifiable data of the participants such as age, gender, education, marital status, type of cancer and its stage, relative to the family caregiver, duration of diagnosis and employment status will be included in the research without giving the names and addresses of the participants.
Also, for the clinical study report, the research results will be provided to the researchers.

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

To whom:
Access to the data is free for researchers interested in this topic

Conditions:
In order to use in other researches and to use the data to improve the treatment of cancer patients

Where to obtain:
To access the data, you can use the email: atefehbeglu20@gmail.com or contact number 09100747091

How to obtain:
In order to access the data correctly, the applicant can contact the researcher through the email or the contact number that is included in the article, and the data will be available to her within 2 weeks.

Comments:
…</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Atefeh jafarbegloo</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Nursing And Midwifery School, Tehran University Of Medical Science, Nosrat St, Tawheed Square, Tehran, Iran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1419733171</zip>
        <telephone>+98 21 6692 7171</telephone>
        <email>Atefehbeglu20@gmail.com</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Atefeh Jafarbegloo</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Nursing And Midwifery School, Tehran University Of Medical Science, Nosrat St, Tawheed Square, Tehran, Iran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1419733171</zip>
        <telephone>+98 21 6692 7171</telephone>
        <email>Atefehbeglu20@gmail.com</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Having a medical file with a cancer diagnosis in stage III or IV
At least 18 years old
Listening and speaking ability to participate in the study
Being aware of the disease and being interested in participating in the study
Having no cognitive impairment (according to the medical records, no mental illness has been recognized and confirmed by a doctor)
Have a family caregiver
Family caregivers who are at least 18 years old
They have sufficient literacy and are the main caregivers of cancer patients</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>The patient's condition worsened
Disinclination to continue studying
Not consenting to participate in the study</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>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group:  3 demographic questionnaires, Beck depression questionnaire and spiritual well-being questionnaire will be used for this study; Before the intervention, the questionnaires will be given to the intervention and control groups, and after completing the questionnaires, the family-oriented dignity therapy protocol will be implemented in the intervention group. In order to carry out the dignity therapy method, three sessions of 30-60 minutes will be considered for 3 weeks. In the first session, the researcher, while introducing the goals of the research, familiarized the participant with the questions of the family-oriented  dignity therapy protocol and provided the necessary opportunity to think about their statements in the next interview session. In the second session, which is 2 to 3 days after The basic meeting will be held, the researcher will guide the client during the interview with the patient-family couple and using the guiding questions of the family-oriented dignity therapy protocol to talk about the patient's life experiences in the context of the family. The participant's statements will be recorded during the interview while obtaining his permission. Then the recorded interviews are transcribed and edited (the questions are focused on eliciting the patients' life experiences in relation to their families, while the caregivers' answers are used to enrich the patients' narratives). In the third session, which is usually held 3 days after the third session, the therapist invites the patient and his family and provides them with the final version of the text to share with them. After the family-centered dignity therapy interventions, the questionnaires will be provided to the intervention and control groups again.</i_keyword>
      <i_keyword>Control group: 3 demographic questionnaires, Beck's depression and spiritual well-being questionnaires will be provided to the patients before the intervention and 10 days after the intervention. At this time, only routine treatments are performed for the intervention group.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Depression score in the Beck questionnaire. Timepoint: The effect of family-oriented dignity therapy on depression before the start of the study and 10 days after the intervention. Method of measurement: Beck depression questionnaire to measure depression.</prim_outcome>
      <prim_outcome>Spiritual well-being score in the Polotzin and Ellison spiritual well-being questionnaire. Timepoint: The effect of family-oriented dignity therapy on spiritual well-being before the start of the study and 10 days after the intervention. Method of measurement: Polotzin and Ellison spiritual well-being questionnaire to measure spiritual well-being.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Age. Timepoint: At the beginning of the study and 10 days after the intervention. Method of measurement: Demographic questionnaire.</sec_outcome>
      <sec_outcome>Sex. Timepoint: At the beginning of the study and 10 days after the intervention. Method of measurement: Demographic questionnaire.</sec_outcome>
      <sec_outcome>Marital. Timepoint: At the beginning of the study and 10 days after the intervention. Method of measurement: Demographic questionnaire.</sec_outcome>
      <sec_outcome>Employment status. Timepoint: At the beginning of the study and 10 days after the intervention. Method of measurement: Demographic questionnaire.</sec_outcome>
      <sec_outcome>Education. Timepoint: At the beginning of the study and 10 days after the intervention. Method of measurement: Demographic questionnaire.</sec_outcome>
      <sec_outcome>Type of cancer. Timepoint: At the beginning of the study and 10 days after the intervention. Method of measurement: Demographic questionnaire.</sec_outcome>
      <sec_outcome>‏Duration of cancer diagnosis. Timepoint: At the beginning of the study and 10 days after the intervention. Method of measurement: Demographic questionnaire.</sec_outcome>
      <sec_outcome>Family caregivers of cancer  patients. Timepoint: At the beginning of the study and 10 days after the intervention. Method of measurement: Demographic questionnaire.</sec_outcome>
      <sec_outcome>Relative to the patient. Timepoint: At the beginning of the study and 10 days after the intervention. Method of measurement: Demographic questionnaire.</sec_outcome>
      <sec_outcome>Duration of care. Timepoint: At the beginning of the study and 10 days after the intervention. Method of measurement: Demographic questionnaire.</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>Tehran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2024-06-09</approval_date>
        <contact_name>Nursing and Midwifery Ethics Committee of Tehran University of Medical Sciences</contact_name>
        <contact_address>Nosrat St, Tawheed Square, Tehran, Iran Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
