<?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>IRCT20181114041660N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-11-24</date_registration>
      <primary_sponsor>Mashhad University of Medical Sciences</primary_sponsor>
      <public_title>The ٍٍEffect of Telephone Counseling and Education on Caregiver Strain and Unmet Needs in Family Caregivers and Self-care Behaviors of Patients with Cancer</public_title>
      <acronym></acronym>
      <scientific_title>The ٍٍEffect of Telephone Counseling and Education on Caregiver Strain and Unmet Needs in Family Caregivers and Self-care Behaviors of Patients with Cancer</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-12-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/35315</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: Block،Put the Four blocks in a sealed envelope and Then they will be arranged in a straightforward Lottery way.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Condition 1: Esophagus Cancer. Condition 2: Stomach Cancer. Condition 3: Colon Cancer. Condition 4: Colon Cancer. Condition 5: Rectum Cancer. Condition 6: Rectum Cancer.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group:In the intervention  group, a 20-minute face-to-face training session will be provided to caregivers of cancer patients.During this meeting, will be briefly explained on how to care for the patient, nutrition, activity and rest, the prevention of infection and the management of the symptoms of the disease and the side effects of chemotherapy and  at the end of the meeting several educational pamphlets includes subjects taught will be given to carers.In addition to face-to-face training and educational pamphlets, the intervention group will receive four telephone consultations within 2 months (in the first course of chemotherapy after entering the study 2 calls and in the second and third chemotherapy course each one will receive a call).In the first telephone interview, a review of educational materials about patient problems and self-care with the patient is conducted and the second session will be discussed with the caregiver about symptoms management, Uncertainty reduction , optimistic attitudes and effective adjustment skills. Intervention 2: Control group: In the control group, a 20-minute face-to-face training session will be provided to caregivers of cancer patients.During this meeting, will be briefly explained on how to care for the patient, nutrition, activity and rest, the prevention of infection and the management of the symptoms of the disease and the side effects of chemotherapy and at the end of the meeting several educational pamphlets includes subjects taught will be given to carers.Carers will receive routine education through nurses and referral to hospital health Education clinics.</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 total potential data can be shared after unidentifiable people

When:
Start the access period 6 months after printing the results

To whom:
Only for researchers working in academic and scientific institutions

Conditions:
The data can be used for other human research and health centers

Where to obtain:
Library of the School of Nursing and Midwifery of Mashhad
ghorbanif941@mums.ac.ir

How to obtain:
Visit the Library of Nursing and Midwifery Faculty of Mashhad

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Ghorbani Fatemeh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Mashhad, Ebme sina St, Nursing and Midwifery Faculty</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9137913199</zip>
        <telephone>+98 51 3859 1511</telephone>
        <email>ghorbanif941@mums.ac.ir</email>
        <affiliation>Mashhad University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Zare Masoud</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Mashhad, Ebne sina St, Nursing and Midwifery Faculty</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9137913199</zip>
        <telephone>+98 51 3859 1511</telephone>
        <email>zaremd@mums.ac.ir</email>
        <affiliation>Mashhad 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 patients: willingness to participate in the study and informed consent
The definitive diagnosis of cancer of the esophagus and stomach and colorectal
Age greater than 18 and less than 65 years
The ability to read and write in Persian
Lack of speech and hearing problems
Candidate of Therapy 3 chemotherapy courses
Having access to the phone
Not a member health team
Lack of support by advocacy group
Inclusion criteria caregivers:  willingness to participate in the study and informed consent
The main caregiver of being patient
The ability to read and write in Persian
Having access to the phone
Lack of speech and hearing problems
The absence of specific psychological problems and the use of medication to treat it
Not a member health team
Lack of support by advocacy group</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>65 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Unwillingness to continue cooperation
Failure to answer telephone calls and disconnect (if He/She does not answer 3 phone calls)
The occurrence of stressful events for carers and patients during an intervention such as divorce, death of close relatives, sick death and job loss
Failure to fully complete all three questionnaire of the self-care patients by the patients and the Burden and Unmet needs by the caregivers
The patient's inappropriate general condition during the intervention so that his continued cooperation is not feasible
Caregiver support by support groups</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>C15</hc_code>
      <hc_code>C16</hc_code>
      <hc_code>C18</hc_code>
      <hc_code>C19</hc_code>
      <hc_code>C20</hc_code>
      <hc_code>C21</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Malignant neoplasm of esophagus</hc_keyword>
      <hc_keyword>Malignant neoplasm of stomach</hc_keyword>
      <hc_keyword>Malignant neoplasm of colon</hc_keyword>
      <hc_keyword>Malignant neoplasm of rectosigmoid junction</hc_keyword>
      <hc_keyword>Malignant neoplasm of rectum</hc_keyword>
      <hc_keyword>Malignant neoplasm of anus and anal canal</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Other</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group:In the intervention  group, a 20-minute face-to-face training session will be provided to caregivers of cancer patients.During this meeting, will be briefly explained on how to care for the patient, nutrition, activity and rest, the prevention of infection and the management of the symptoms of the disease and the side effects of chemotherapy and  at the end of the meeting several educational pamphlets includes subjects taught will be given to carers.In addition to face-to-face training and educational pamphlets, the intervention group will receive four telephone consultations within 2 months (in the first course of chemotherapy after entering the study 2 calls and in the second and third chemotherapy course each one will receive a call).In the first telephone interview, a review of educational materials about patient problems and self-care with the patient is conducted and the second session will be discussed with the caregiver about symptoms management, Uncertainty reduction , optimistic attitudes and effective adjustment skills.</i_keyword>
      <i_keyword>Control group: In the control group, a 20-minute face-to-face training session will be provided to caregivers of cancer patients.During this meeting, will be briefly explained on how to care for the patient, nutrition, activity and rest, the prevention of infection and the management of the symptoms of the disease and the side effects of chemotherapy and at the end of the meeting several educational pamphlets includes subjects taught will be given to carers.Carers will receive routine education through nurses and referral to hospital health Education clinics.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Caregiver Strain. Timepoint: Before the intervention and at the end of the intervention (the end of the second month). Method of measurement: Zarit caregiver Burden Inventory.</prim_outcome>
      <prim_outcome>Unmet needs. Timepoint: Before the intervention and at the end of the intervention (the end of the second month). Method of measurement: Supportive Care Needs Survey Partners and Caregivers.</prim_outcome>
      <prim_outcome>Self-care behaviors. Timepoint: Before the intervention and at the end of the intervention (the end of the second month). Method of measurement: Nail Self- care Dairy 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>Mashhad University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2018-10-16</approval_date>
        <contact_name>The Ethics Committee of Mashhad University of Medical Sciences</contact_name>
        <contact_address>Ebne sina St, Mashhad Nursing and Midwifery Faculty Mashhad Razavi Khorasan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
