<?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>IRCT20260801070485N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2026-08-10</date_registration>
      <primary_sponsor>Kerman University of Medical Sciences</primary_sponsor>
      <public_title>The Effect of Conversation and Life Storytelling on the Sense of Dignity and Meaning in Life Among Older Adults with Cancer</public_title>
      <acronym></acronym>
      <scientific_title>The Effectiveness of Narrative Therapy on Dignity and Meaning in Life Among Elderly Cancer Patients with Palliative Care Needs Hospitalized in Oncology Wards</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2026-08-11</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>86</target_size>
      <recruitment_status>Recruiting</recruitment_status>
      <url>https://irct.ir/trial/92131</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: In this study, participants will be allocated to the intervention and control groups using simple randomization. The unit of randomization will be the individual participant, and after entering the study and completing the baseline assessment process, each participant will be assigned to either the intervention group (receiving narrative therapy) or the control group. The random allocation sequence will be generated using a random number generation software. To ensure allocation concealment, the allocation sequence will be prepared by an independent person who is not involved in the implementation or assessment of the study and will be kept in opaque, sealed, and sequentially numbered envelopes. After the participant’s final inclusion in the study, the corresponding envelope will be opened and the assigned group will be revealed, Blinding description: Due to the nature of the narrative therapy intervention, blinding of participants and the intervention provider is not feasible, as participants will be aware of whether they have received the intervention sessions. In addition, the principal researcher and the person delivering the intervention will be aware of participants’ group allocation. However, the data collector and outcome assessor will be blinded to participants’ allocation to the intervention and control groups. The post-intervention questionnaires will be completed and recorded by an outcome assessor who is not involved in the intervention process to minimize the risk of assessment bias. If possible, data analysis will also be performed using coded groups (e.g., Group A and Group B) without revealing the actual group assignments to the data analyst.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Cancer (in older adults requiring palliative care).</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Participants in this group will receive individual narrative therapy in addition to routine oncology care and standard palliative care. The intervention will be delivered by a psychologist trained in narrative therapy based on the White and Epston framework.The intervention consists of eight individual sessions lasting 45–60 minutes, conducted twice weekly over four consecutive weeks at the patient's bedside in the oncology ward.The sessions include establishing a therapeutic relationship and collecting the patient's life narrative, externalizing the illness from the patient's identity, identifying unique outcomes and meaningful life experiences, reconstructing the patient's life story focusing on meaning, strengths, achievements, and valuable relationships, and preparing a written reconstructed life narrative document.Post-test assessments will be conducted after completion of the eighth session. Intervention 2: Control group:  Participants in this group will receive only routine oncology care and standard palliative care. Usual care includes routine medical and nursing interventions, symptom management, pain control, management of cancer-related symptoms, and routine psychosocial support provided in the ward.No structured psychological intervention or narrative therapy will be provided during the study period. After completion of data collection, narrative therapy will be offered to participants in the control group for ethical considerations.</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>No - There is not a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for not sharing IPD is Individual participant data will not be shared due to confidentiality and privacy considerations and the sensitive nature of clinical information of patients with cancer.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Zahra Khalilzadeh-Farsangi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Haft Bagh Alavi</address>
        <city>Kerman</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7617787177</zip>
        <telephone>+98 34 2345 6789</telephone>
        <email>zahrakhlilzde@gmail.com</email>
        <affiliation>Kerman University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Zahra Khalilzadeh-Farsangi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Haft Bagh Alavi</address>
        <city>Kerman</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7617787177</zip>
        <telephone>034332533787</telephone>
        <email>zahrakhlilzde@gmail.com</email>
        <affiliation>Kerman University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Have a confirmed diagnosis of cancer based on medical records.
Be hospitalized in the oncology wards of hospitals affiliated with Kerman University of Medical Sciences.
Have a need for receiving palliative care.
Have the ability to communicate verbally and participate in narrative therapy sessions.
Have sufficient cognitive awareness to answer questions and complete research instruments.
Provide written informed consent to participate in the study.
Having an age between 60 and 80 years</inclusion_criteria>
      <agemin>60 years</agemin>
      <agemax>80 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Having severe cognitive impairment or dementia based on medical records or initial assessment.
Having severe psychiatric disorders that affect the ability to participate in the study.
Being unable to establish appropriate verbal communication.
Receiving concurrent similar psychological interventions (such as narrative therapy or life review therapy).
Having an unstable or critical physical condition that prevents participation in intervention sessions.</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>Lifestyle</i_code>
      <i_code>Lifestyle</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Participants in this group will receive individual narrative therapy in addition to routine oncology care and standard palliative care. The intervention will be delivered by a psychologist trained in narrative therapy based on the White and Epston framework.The intervention consists of eight individual sessions lasting 45–60 minutes, conducted twice weekly over four consecutive weeks at the patient's bedside in the oncology ward.The sessions include establishing a therapeutic relationship and collecting the patient's life narrative, externalizing the illness from the patient's identity, identifying unique outcomes and meaningful life experiences, reconstructing the patient's life story focusing on meaning, strengths, achievements, and valuable relationships, and preparing a written reconstructed life narrative document.Post-test assessments will be conducted after completion of the eighth session.</i_keyword>
      <i_keyword>Control group:  Participants in this group will receive only routine oncology care and standard palliative care. Usual care includes routine medical and nursing interventions, symptom management, pain control, management of cancer-related symptoms, and routine psychosocial support provided in the ward.No structured psychological intervention or narrative therapy will be provided during the study period. After completion of data collection, narrative therapy will be offered to participants in the control group for ethical considerations.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Patient dignity score measured using the Patient Dignity Inventory (PDI) before and after the narrative therapy intervention, and changes will be compared between the intervention and control groups. Timepoint: Outcome variables will be measured at two time points: before the intervention (pre-test) and immediately after completion of the narrative therapy intervention (post-test, at the end of the fourth week). Method of measurement: Patient Dignity Inventory, a 25-item questionnaire used to assess dignity-related distress among patients with life-threatening illnesses.</prim_outcome>
      <prim_outcome>Meaning in life score measured using the Meaning in Life Questionnaire (MLQ) before and after the narrative therapy intervention, and changes will be compared between the intervention and control groups. Timepoint: Outcome variables will be measured at two time points: before the intervention (pre-test) and immediately after completion of the narrative therapy intervention (post-test, at the end of the fourth week). Method of measurement: Meaning in Life Questionnaire, a questionnaire assessing two dimensions of meaning in life, including presence of meaning and search for meaning.</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>Kerman University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2026-07-20</approval_date>
        <contact_name>Kerman University of Medical Sciences</contact_name>
        <contact_address>Haft Bagh Alavi Kerman Kerman Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
