<?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>IRCT20150607022592N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-09-16</date_registration>
      <primary_sponsor>Mashhad University of Medical Sciences</primary_sponsor>
      <public_title>The effect of using supportive-educative self-care program with the approach of telenursing on hope and body image in women with breast cancer undergoing mastectomy</public_title>
      <acronym></acronym>
      <scientific_title>The effect of using supportive-educative self-care program with the approach of telenursing on hope and body image in women with breast cancer undergoing mastectomy</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-10-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>108</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/65738</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: In this study, for randomization, permutation blocks of 4 will be retrieved using Excel software. with the explanation that each of the blocks has 4 members and the shape of the blocks can be as follows:
[ABAB4],[BB4AA],[BABA4], …
Codes A and B are assigned to the accident related to the intervention and control groups. The aforementioned site randomly selects 18 blocks out of all the four possible blocks so that all patients are included in the study.
Allocation Concealment method:
At first, replacement blocks will be provided by the statistics professor. Each block is placed separately in sealed envelopes and all envelopes are provided to a research assistant. Then, at the beginning of sampling, the researcher asks the researcher to open the first envelope and tell the researcher based on random letters which group the first patient will be in, and the sampling will be done in the same way until the end of the research.</study_design>
      <phase>3</phase>
      <hc_freetext>Body Image disturbance in Patients undergoing mastectomy surgery.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: The intervention in this research includes firstly designing, construction and validation of a supportive-educative self-care application for breast cancer patients and secondly implementing  a self-care educational support program through telenursing using the application and remote communication with the patient through the WhatsApp virtual network during a a clinical trial research. the intervention group, after obtaining informed consent from the patient and having the code of ethics at the beginning of the researcher's acquaintance with the patient in the surgical department, demographic and disease data, mental body image questionnaire and Herth hope index will be given to the patient for preliminary examination. At this stage, the effort to create a suitable relationship between the nurse and the patient by using active listening, using appropriate sentences to prove professional competence and having up-to-date information of the nurse to gain trust and encourage the patient to cooperate in the process of care and education, which is Virtualization will continue, then the self-care application will be provided to the patients in person undergoing mastectomy surgery, and the researcher will teach the patients how to install the application on the smart phone, and the researcher will explain how to work with the application. is given and after installing the application, the patient uses it in the presence of the researcher and asks his questions. Then the researcher will establish the first message through WhatsApp with the patient. During the period of one month, by communicating daily with the patient (4 days a week) through WhatsApp, he is asked to gradually use the app based on his preferences and learning needs, and at the same time, the researcher provides related support, such as further explanations in the field of activities. Self-care needed by the patient and responding to his care needs, and emotional support such as calming the patient using various counseling and sedation techniques. Use of WhatsApp group: The purpose of forming groups is to interact with similar patients in a group and share daily problems caused by the disease in the field of quality of life, including: nutritional needs and daily activities and mental problems, and to share mental concerns about the side effects of drugs and Also, examining similar challenges and answering questions in the presence of the researcher. In general, sharing the experiences of different people and taking role models from them to increase awareness will be done according to the need for training in self-care. These sessions will be twice a week with a duration of at least 30 to 45 minutes, and the number of sessions will increase depending on the needs of the patients. Intervention 2: Control group: The control group consists of women with breast cancer undergoing mastectomy hospitalized in the surgery departments of Omid and Imam Reza Hospitals. At the time of discharge, after filling out the consent questionnaire to participate in the research, the usual procedures of the department are performed for these patients, which includes face-to-face training of nurses. to these patients during discharge and providing them with educational pamphlets. In the following, the contact number of the researcher will be provided to these patients so that they can raise any questions and problems with the researcher. Phone calls are optional in this group of patients and the researcher does not communicate with this group in a targeted manner like 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>No - There is not a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for not sharing IPD is There are no plans to release it</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Nahid Aghebati</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Daneshgah Street, Ebne Sina Aven, Nursing and Midwifery School, Mashhad University of Medical Sciences</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9137913199</zip>
        <telephone>+98 51 3859 1511</telephone>
        <email>Aghebatin@mums.ac.ir</email>
        <affiliation>Mashhad University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Nahid Aghebati</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Daneshgah Street, Ebne Sina Avenu, Nursing and Midwifery School, Mashhad University of Medical Sciences</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9137913199</zip>
        <telephone>+98 51 3859 1511</telephone>
        <email>Aghebatin@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>At least three days have passed since the surgery
At least one month has passed since the diagnosis of cancer
Be literate in reading and writing
have access to a smartphone
The age of patients should be in the range of 18 to 60 years old
Absence of metastatic cancer so that the patient has not metastasized to other parts of the body in the pathology report or Positron emission tomography scan</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>60 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Not using the application for more than ten consecutive days or less than 20% of referrals to the application
Failure to provide feedback in WhatsApp consultations for more than four sessions
Sudden hospitalization due to life-threatening problems</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>Code C50</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Malignant neoplasm of breast</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 intervention in this research includes firstly designing, construction and validation of a supportive-educative self-care application for breast cancer patients and secondly implementing  a self-care educational support program through telenursing using the application and remote communication with the patient through the WhatsApp virtual network during a a clinical trial research. the intervention group, after obtaining informed consent from the patient and having the code of ethics at the beginning of the researcher's acquaintance with the patient in the surgical department, demographic and disease data, mental body image questionnaire and Herth hope index will be given to the patient for preliminary examination. At this stage, the effort to create a suitable relationship between the nurse and the patient by using active listening, using appropriate sentences to prove professional competence and having up-to-date information of the nurse to gain trust and encourage the patient to cooperate in the process of care and education, which is Virtualization will continue, then the self-care application will be provided to the patients in person undergoing mastectomy surgery, and the researcher will teach the patients how to install the application on the smart phone, and the researcher will explain how to work with the application. is given and after installing the application, the patient uses it in the presence of the researcher and asks his questions. Then the researcher will establish the first message through WhatsApp with the patient. During the period of one month, by communicating daily with the patient (4 days a week) through WhatsApp, he is asked to gradually use the app based on his preferences and learning needs, and at the same time, the researcher provides related support, such as further explanations in the field of activities. Self-care needed by the patient and responding to his care needs, and emotional support such as calming the patient using various counseling and sedation techniques. Use of WhatsApp group: The purpose of forming groups is to interact with similar patients in a group and share daily problems caused by the disease in the field of quality of life, including: nutritional needs and daily activities and mental problems, and to share mental concerns about the side effects of drugs and Also, examining similar challenges and answering questions in the presence of the researcher. In general, sharing the experiences of different people and taking role models from them to increase awareness will be done according to the need for training in self-care. These sessions will be twice a week with a duration of at least 30 to 45 minutes, and the number of sessions will increase depending on the needs of the patients.</i_keyword>
      <i_keyword>Control group: The control group consists of women with breast cancer undergoing mastectomy hospitalized in the surgery departments of Omid and Imam Reza Hospitals. At the time of discharge, after filling out the consent questionnaire to participate in the research, the usual procedures of the department are performed for these patients, which includes face-to-face training of nurses. to these patients during discharge and providing them with educational pamphlets. In the following, the contact number of the researcher will be provided to these patients so that they can raise any questions and problems with the researcher. Phone calls are optional in this group of patients and the researcher does not communicate with this group in a targeted manner like the intervention group.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Hope score in Herth Hope Index. Timepoint: When entering the study and one month after entering the study. Method of measurement: Herth Hope Index (HHI).</prim_outcome>
      <prim_outcome>The  body image score based on the Body Image after Breast Cancer Questionnaire (BIBCQ). Timepoint: When entering the study and one month after entering the study. Method of measurement: Body Image after Breast Cancer Questionnaire (BIBCQ).</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>Vice President of Research and Technology of Mashhad University of Medical Sciences and Health Services</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-07-05</approval_date>
        <contact_name>Ethics committee of Mashhad University of Medical Sciences</contact_name>
        <contact_address>Daneshgah St, Ebn Sina Ave, Nursing and Midwifery School, Mashhad University of Medical Sciences Mashhad Razavi Khorasan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
