<?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>IRCT20150607022592N3</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-11-06</date_registration>
      <primary_sponsor>Mashhad University of Medical Sciences</primary_sponsor>
      <public_title>The effect of adaptation nurturance  on the self-efficacy and quality of life of patients with colorectal cancer  undergoing chemotherapy</public_title>
      <acronym></acronym>
      <scientific_title>Comparing the effect of adaptation nurturance using the Adaptive Potential Assessment Model (APAM) and routine education praogram on the self-efficacy and quality of life of patients with colorectal cancer  undergoing chemotherapy</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-11-08</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>70</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/73035</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: At first, using statistical software, 18 permutation blocks of size 4 will be recovered. Then the units of each block are placed separately in sealed envelopes. Before starting the sampling, the researcher asks one of the ward nurses to open the first envelope and open the characters inside the envelope for the researcher, according to the patients who met the criteria for entering the study and consent to participate in the study with the help of the consent form. They have consciously announced that they will be placed in the intervention and control groups in parallel. This process will continue until the completion of the samples in two groups based on the sample size of 70 people (35 people in each group).</study_design>
      <phase>3</phase>
      <hc_freetext>Colorectal Cancer.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: The intervention begins in the second phase of chemotherapy  after obtaining informed consent.  First, questionnaires to check demographic information, self-efficacy and quality of life are completed by the patient. adaptation Nurturance as an intervention of the present study is implemented in two stages of modeling and role modeling. Nurturance includes educational, supportive and caring interventions. In the modeling stage, the researcher tries to gain the patient's trust and use the process of active listening to determine the patient's adaptation status by using a questionnaire to determine the degree of adaptation based on the nursing theory of modeling and role modeling  and determine the existing stressors. Then, a pattern of the patient's adaptation status is drawn, including three phases: arousal, equilibrium, and impoverishment. At this stage, the researcher can determine the patient's condition based on the identification of various internal and external stressors (related stressors of colorectal cancer patients according to existing articles It often includes the disorder of imbalanced nutrition less than  body requirements, decreased fluid volume, not knowing how to take care of the colostomy bag, as well as nausea and vomiting and diarrhea caused by chemotherapy.) But  based on the  unique needs of each patient some other the stressors might be determined. Then, in the role modeling stage, the researcher tries to bring the patient's educational support closer to balance by using appropriate care interventions, if the patient is in the phase of equilibrium or impoverishment. The researcher tries to implement the process of modeling and role modeling for the patient during 3 to 5 face-to-face sessions of 30 to 45 minutes. At least two face-to-face sessions are held in each chemotherapy period. And between the chemotherapy courses, video communication is established with the patient twice using the virtual network, and the patient's condition is evaluated and the necessary recommendations are given to the patient. In the third and fourth stages of chemotherapy (one month and two months after the start of the intervention), the level of self-efficacy and the quality of life of the patient are measured. Intervention 2: Control group: In the control group, all the usual care and training is done in hospitals, which includes the use of educational pamphlets and participation in health clinic training programs. along with participation in the telephone follow-ups that are done by the nurses of the health clinic of the hospitals. Educational measures and follow-ups by phone and virtual network are done in the intervention group with the coordination of the hospital's health education clinic.</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>Undecided - It is not yet known if there will be a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for indecision in sharing IPD is It is possible to modify it while studying</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Nahid Aghebati</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Nursing and Midwifery School; Shahid Dr Kharazmi  Educational institute ;Pardis of Mashhad university of Medical Sciences; The East door of Ferdowsi University; Azadi Square, Mashhad</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9178948564</zip>
        <telephone>+98 51 3800 2000</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>Nursing and Midwifery School; Shahid Dr Kharazmi  Educational institute ;Pardis of Mashhad university of Medical Sciences; The East door of Ferdowsi University; Azadi Square, Mashhad</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9177948564</zip>
        <telephone>+98 51 3800 2000</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>Being at the age of 30-80 years old
Having Colorectal cancer with an oncologist special diagnosis
Having a caregiver at home
Being Persian
Having the ability to speak
Having a personal smart phone</inclusion_criteria>
      <agemin>30 years</agemin>
      <agemax>80 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Reducing level of consciousness and being refereed to ICU
Evidence of metastasis in the description of the patient's operation
Having a diagnosed psychological disease</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>C18-C21</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Malignant neoplasms of digestive organs: Malignant neoplasm of colon, Malignant neoplasm of rectosigmoid junction, Malignant neoplasm of rectum, Malignant neoplasm of anus and anal canal</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: The intervention begins in the second phase of chemotherapy  after obtaining informed consent.  First, questionnaires to check demographic information, self-efficacy and quality of life are completed by the patient. adaptation Nurturance as an intervention of the present study is implemented in two stages of modeling and role modeling. Nurturance includes educational, supportive and caring interventions. In the modeling stage, the researcher tries to gain the patient's trust and use the process of active listening to determine the patient's adaptation status by using a questionnaire to determine the degree of adaptation based on the nursing theory of modeling and role modeling  and determine the existing stressors. Then, a pattern of the patient's adaptation status is drawn, including three phases: arousal, equilibrium, and impoverishment. At this stage, the researcher can determine the patient's condition based on the identification of various internal and external stressors (related stressors of colorectal cancer patients according to existing articles It often includes the disorder of imbalanced nutrition less than  body requirements, decreased fluid volume, not knowing how to take care of the colostomy bag, as well as nausea and vomiting and diarrhea caused by chemotherapy.) But  based on the  unique needs of each patient some other the stressors might be determined. Then, in the role modeling stage, the researcher tries to bring the patient's educational support closer to balance by using appropriate care interventions, if the patient is in the phase of equilibrium or impoverishment. The researcher tries to implement the process of modeling and role modeling for the patient during 3 to 5 face-to-face sessions of 30 to 45 minutes. At least two face-to-face sessions are held in each chemotherapy period. And between the chemotherapy courses, video communication is established with the patient twice using the virtual network, and the patient's condition is evaluated and the necessary recommendations are given to the patient. In the third and fourth stages of chemotherapy (one month and two months after the start of the intervention), the level of self-efficacy and the quality of life of the patient are measured.</i_keyword>
      <i_keyword>Control group: In the control group, all the usual care and training is done in hospitals, which includes the use of educational pamphlets and participation in health clinic training programs. along with participation in the telephone follow-ups that are done by the nurses of the health clinic of the hospitals. Educational measures and follow-ups by phone and virtual network are done in the intervention group with the coordination of the hospital's health education clinic.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Self-efficacy score. Timepoint: Before the intervention - the first month and the second month after the start of the study. Method of measurement: Cancer Behavior Inventory–Brief Version (CBI-B).</prim_outcome>
      <prim_outcome>Quality of life score. Timepoint: Before the intervention; 1 month and 2 months later. Method of measurement: Quality of life questionnaire-cancer 30 (EORTC QLQ-C30).</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>2023-07-11</approval_date>
        <contact_name>Research Ethics Committees of School of Nursing &amp; Midwifery; Mashhad University of Medical Sciences</contact_name>
        <contact_address>Nursing and Midwifery School; Shahid Dr Kharazmi  Educational institute ;Pardis of Mashhad university of Medical Sciences; The East door of Ferdowsi University; Azadi Square, Mashhad Mashhad Razavi Khorasan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
