<?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>IRCT2016010725897N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2016-05-28</date_registration>
      <primary_sponsor>Isfahan University of Medical Sciences</primary_sponsor>
      <public_title>The effect of a Communication Program on the Psychological Distress of  Elderly Cancer Patients</public_title>
      <acronym></acronym>
      <scientific_title>The effect of a Communication Program on the Psychological Distress of  Elderly Cancer Patients who reffered to the Selected Centers Affiliated to the Isfahan Univercity of Medical Sciences in 2015.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2015-11-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>64</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/21606</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Psychological Distress.</hc_freetext>
      <i_freetext>Intervention 1: In the experimental group communications during the six sessions of approximately twenty minutes due to the conditions and needs of patients was performed. During the three-week sessions, twice a week were conducted individually and in person. Telephone follow-up to attend the next meeting to coordinate and encourage the patient to do homework. Time sessions with the agreement of the patients was determined. All meetings were held in the hospital and at the time of admission. Training manual in the test group was placed in the first session, they were asked to provide manual control group did not. Join this session to order and mutual understanding, explain the objectives of the intervention, simple and concise explanation about cancer and its treatment process and effects of this disease on patients' quality of life. Patients the opportunity to talk about various topics, including the expression of uncertainties, questions and concerns and reveal the deepest feelings and emotions related to their experiences of illness and distress-inducing events were live. In the speech, physical, psychological, social and spiritual patient was evaluated as a basis for subsequent meetings. The next meeting, which is to help the client to cope and adapt to problems using strategies based assignments and training manual approved by the faculty of professors, to be discussed, explained.In the second session to encourage clients to speak on the issue of the impact of the disease on physical aspects (impact of the disease on physical conditions, beliefs and expectations of patients about their condition, plans and hopes for the progress of the disease), were encouraged. And obligations commensurate with their potential problems, it is presented. And the subjects were asked to do that task to the next meeting. In the second session, clients talking about psychological distress caused by the disease subject (patient relationship between different emotions, physical symptoms and disabilities caused by the disease and patients' concerns about the ability to adapt, loss of control, and readiness to accept help and discuss issues surrounding death), were encouraged. And adaptation strategies in accordance with the manual and training tailored to the patient's condition was presented to them. And the sample was asked to do the task to the next meeting. In the fourth session, clients to talk about the social effects of the disease (the disease affect behavior and mood, and ability to perform the role of the full impact of the disease on individuals favorite client) were encouraged. And how to manage it in accordance with the instruction manual and tailored to the patient, was presented to them. And the sample was asked to do the task to the next meeting. In the fifth session, clients are talking about spiritual matters illness and disease issues (issues surrounding the concept of disease, suicide and death, the ability to modify and spiritual changes, compromise and consistent with the spiritual, forgiveness of others and accept unfinished works), were encouraged. And the appropriate task presented to them. And the sample was asked to do the task to the next meeting. Sixth session, summing up previous sessions and announced the termination of negotiations. Also, researchers through questionnaires completed the questionnaire psychological distress, paid in the last session. In each session, then discuss things, applicable solutions discussed, and the optimum solution according to requirements and potential problems the patient is recommended. They also provide the basis for the assignment to be patient. And client feedback in each session examined the implementation of assignments in previous sessions. Telephone researcher also laid the experimental and control groups, so if you create questions about the contents of the manual, they can  contact the researcher. Intervention 2: The control group received routine care. Furthermore, after three weeks by nearly two-hour meeting, the contents of the manual are briefly described for each of the control group. And measures of psychological distress were completed the questionnaire again. In the end, brochure, available to patients and their families were in the control group. Telephone researcher also laid the experimental and control groups, so if you create questions about the contents of the manual, they can  contact the researcher.</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></results_IPD_plan>
      <results_IPD_description></results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Masoud Bahrami</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of Nursing and Midwifery, University of Medical Sciences, St. thousand acres, Isfahan, Iran</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 31 3792 7542</telephone>
        <email>bahrami@nm.mui.ac.ir</email>
        <affiliation>Isfahan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Fateme Hejazi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of Nursing and Midwifery, University of Medical Sciences, St. thousand acres, Isfahan, Iran</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 31 3792 7542</telephone>
        <email>fahejazi@nm.mui.ac.irfahejazi@yahoo.comresiliency66@yahoo.com</email>
        <affiliation>Isfahan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: Seniors aged 60 years or older with cancer (Types of Cancer); The definitive diagnosis of cancer by medical oncologist &amp; Life expectancy of at least six months (According to serfaty et al. 2012); Patients are aware of their cancer diagnosis; Patients have the ability to talk and communicate verbally; Willingness to participate in the study and randomly placed in groups; Previous participate in the meetings of up to six months before other treatments (Like therapy, spiritual therapy, relationship therapy, etc.) (According to serfaty et al. 2012); Lack of diseases other than cancer such as acute febrile or chronic physical disorders specialist physician and medical records. (Like the flu, debilitating diseases, cardiovascular, endocrine, respiratory, liver, skeletal muscle, kidney); Lack of mental disease or mental illness who have specialist physician and the patient is inserted; The absence of distress-causing accident, according to the patient in the last six months (Such as the recent death of a loved one such as a spouse or close friend, the loss of everything that is valuable for the individual, divorce, incurable diseases, loss of limb, loss of jobs, relocated to a new city, bankruptcy financial debt severe, imprisonment, disputes and persistent inconsistency with wife); Lack of addiction to narcotics and psychotropic substances, according to the patient and medical records&#13;
Exclusion criteria: Not wanting to continue cooperation in research; The use of other types of communication programs while studying; Inability to attend meetings regularly so that communication meetings have missed two or more consecutive meetings; Elderly death during the study</inclusion_criteria>
      <agemin>60 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F99-F99</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Mental disorder, not otherwise specified</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Other</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>In the experimental group communications during the six sessions of approximately twenty minutes due to the conditions and needs of patients was performed. During the three-week sessions, twice a week were conducted individually and in person. Telephone follow-up to attend the next meeting to coordinate and encourage the patient to do homework. Time sessions with the agreement of the patients was determined. All meetings were held in the hospital and at the time of admission. Training manual in the test group was placed in the first session, they were asked to provide manual control group did not. Join this session to order and mutual understanding, explain the objectives of the intervention, simple and concise explanation about cancer and its treatment process and effects of this disease on patients' quality of life. Patients the opportunity to talk about various topics, including the expression of uncertainties, questions and concerns and reveal the deepest feelings and emotions related to their experiences of illness and distress-inducing events were live. In the speech, physical, psychological, social and spiritual patient was evaluated as a basis for subsequent meetings. The next meeting, which is to help the client to cope and adapt to problems using strategies based assignments and training manual approved by the faculty of professors, to be discussed, explained.In the second session to encourage clients to speak on the issue of the impact of the disease on physical aspects (impact of the disease on physical conditions, beliefs and expectations of patients about their condition, plans and hopes for the progress of the disease), were encouraged. And obligations commensurate with their potential problems, it is presented. And the subjects were asked to do that task to the next meeting. In the second session, clients talking about psychological distress caused by the disease subject (patient relationship between different emotions, physical symptoms and disabilities caused by the disease and patients' concerns about the ability to adapt, loss of control, and readiness to accept help and discuss issues surrounding death), were encouraged. And adaptation strategies in accordance with the manual and training tailored to the patient's condition was presented to them. And the sample was asked to do the task to the next meeting. In the fourth session, clients to talk about the social effects of the disease (the disease affect behavior and mood, and ability to perform the role of the full impact of the disease on individuals favorite client) were encouraged. And how to manage it in accordance with the instruction manual and tailored to the patient, was presented to them. And the sample was asked to do the task to the next meeting. In the fifth session, clients are talking about spiritual matters illness and disease issues (issues surrounding the concept of disease, suicide and death, the ability to modify and spiritual changes, compromise and consistent with the spiritual, forgiveness of others and accept unfinished works), were encouraged. And the appropriate task presented to them. And the sample was asked to do the task to the next meeting. Sixth session, summing up previous sessions and announced the termination of negotiations. Also, researchers through questionnaires completed the questionnaire psychological distress, paid in the last session. In each session, then discuss things, applicable solutions discussed, and the optimum solution according to requirements and potential problems the patient is recommended. They also provide the basis for the assignment to be patient. And client feedback in each session examined the implementation of assignments in previous sessions. Telephone researcher also laid the experimental and control groups, so if you create questions about the contents of the manual, they can  contact the researcher.</i_keyword>
      <i_keyword>The control group received routine care. Furthermore, after three weeks by nearly two-hour meeting, the contents of the manual are briefly described for each of the control group. And measures of psychological distress were completed the questionnaire again. In the end, brochure, available to patients and their families were in the control group. Telephone researcher also laid the experimental and control groups, so if you create questions about the contents of the manual, they can  contact the researcher.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Psychological Distress. Timepoint: Before intervention, after intervention. Method of measurement: Kessler Psychological Distress Scale.</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>Isfahan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2015-11-21</approval_date>
        <contact_name>University of Medical Sciences, Isfahan</contact_name>
        <contact_address>School of Nursing and Midwifery, University of Medical Sciences, St. thousand acres, Isfahan, Iran Isfahan  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
