<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04480229</url>
  </required_header>
  <id_info>
    <org_study_id>50687469-1280-2190-14</org_study_id>
    <nct_id>NCT04480229</nct_id>
  </id_info>
  <brief_title>Telenursing and Breast Cancer: The Turkish Case</brief_title>
  <official_title>A Randomized Controlled Study on the Influence of Telenursing Services to the Chemotherapy Treatment of Breast Cancer Patients: The Turkish Case</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Saglik Bilimleri Universitesi Gulhane Tip Fakultesi</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Saglik Bilimleri Universitesi Gulhane Tip Fakultesi</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study aims to determine the effectiveness of telenursing services on chemotherapy&#xD;
      symptoms and comfort levels in patients with breast cancer in Turkey.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study aims to determine the effectiveness of telenursing services on chemotherapy&#xD;
      symptoms and comfort levels in patients with breast cancer in Turkey. The study employs an&#xD;
      experimental research methodology with a sample of 96 ambulatory patients (48 experimental,&#xD;
      48 control) who were receiving chemotherapy for breast cancer for the first time in a state&#xD;
      hospital. Research data were collected by using &quot;Patient Information Form&quot;, &quot;Edmonton Symptom&#xD;
      Assessment Scale&quot;, &quot;General Comfort Questionnaire, &quot;Symptoms Follow-up Form&quot;, and &quot;Telephone&#xD;
      Call Form&quot;. The experimental group received telenursing service every week until the end of&#xD;
      the four-cycle chemotherapy treatment, which started one week after the first treatment. The&#xD;
      control group did not receive any intervention. Investigators analyzed data with SPSS 15.0&#xD;
      (Statistical Package for the Social Sciences) with comparative statistical methods of&#xD;
      MannWhitney U Test, Chi-Square Test, One Way Analysis of Variance in Repeated Measurements,&#xD;
      and Pearson Correlation.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 6, 2016</start_date>
  <completion_date type="Actual">June 22, 2017</completion_date>
  <primary_completion_date type="Actual">June 20, 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Edmonton Symptom Assessment System</measure>
    <time_frame>10 minutes</time_frame>
    <description>This tool is designed to assist in the assessment of symptoms common in cancer patients: pain,fatique, nausea, sadness, anxiety, insomnia, anorexia, wellbeing and shortness of breath, change in skin-nails, mucositis and numbness in hands. The patient circles the most appropriate number to indicate where the symptom is between &quot;0&quot; and &quot;10&quot;. &quot;0&quot; is the minimum value, which means there is no change and it is a better outcome for the patient. &quot;10&quot; is the maximum value, means that the symptom level is the highest, which is a worse outcome for the patient.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>General Comfort Questionnaire</measure>
    <time_frame>10 minutes</time_frame>
    <description>It is used to evaluate the situation of achieving the expected comfort increase result with nursing interventions that provide comfort. The scale, which is a four-point likert type, has a total of 48 items, 24 items are positive and 24 items are negative.&#xD;
The lowest value that can be taken is 1 which indicates low comfort and this is a worse outcome. The highest value 4 indicates high comfort, which is a better outcome. The response patterns of the scale, which consists of positive and negative items, are given in mixed form. Accordingly, from positive statements; high score (4p) indicates high comfort, low score (1p) indicates low comfort, while negative items indicate low comfort (1p), high score (4p) low comfort.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">96</enrollment>
  <condition>Breast Cancer Female</condition>
  <arm_group>
    <arm_group_label>Intervention Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>After the first treatment, every week the patients were called and consulted by telenursing. During the next there chemotherapy treatments, Edmonton Symptom Assessment System and General Comfort Questionnaire were filled. The study ended with the fourth cycle chemotherapy. A total of six telephone calls and 3 face-to-face follow-ups were done with each of the intervention group patients. Face-to-face follow-up with patients during chemotherapy treatments lasted for about 20-30 minutes, and patients were evaluated three times in terms of symptom severity and comfort level.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>No Intervention: Control Group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>During their first treatment the &quot;Patient Identification Form&quot; was filled and they were trained, which is the routine practice of the clinic. Patients were informed about the &quot;Symptom follow-up form&quot;, asked to mark the symptoms and signs they experienced due to the disease and treatment in the form between the two chemotherapy treatments and to note when they experienced and how they resolved this symptom. When the patients came to the second treatment, the first follow-up of the patients was done. The investigator filled Edmonton Symptom Assessment System and General Comfort Questionnaire forms via face-to-face interviews. The &quot;Symptom Follow-up Form&quot; given to the patients in the previous chemotherapy treatment was collected and the same new form was given. They were requested to bring this form in their next treatment. The same protocol was followed during the third and fourth chemotherapy treatment</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Telenursing and Counseling</intervention_name>
    <description>After the first face-to-face training, counseling on the phone was conducted every week for four cycles of chemotherapy treatment. In total, six counseling sessions and four face-to-face training sessions were conducted for each patient.</description>
    <arm_group_label>Intervention Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  is volunteering to participate in the research,&#xD;
&#xD;
          -  is 18 years of age or over,&#xD;
&#xD;
          -  can communicate in Turkish,&#xD;
&#xD;
          -  has Turkish literacy skills,&#xD;
&#xD;
          -  has no hearing, vision problems, and mental disability that may hinder communication,&#xD;
&#xD;
          -  is female,&#xD;
&#xD;
          -  has a diagnosis of breast cancer for the first time in her life and consequently&#xD;
             receiving chemotherapy treatment in the same protocols for the first time,&#xD;
&#xD;
          -  did not have a different diagnosis of cancer and related chemotherapy treatment.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Having been diagnosed with breast cancer before and received chemotherapy treatment&#xD;
             accordingly,&#xD;
&#xD;
          -  Having been diagnosed with different cancers before and had chemotherapy treatment&#xD;
             related to it,&#xD;
&#xD;
          -  Cancer treatment with oral medications,&#xD;
&#xD;
          -  Refuse to participate in the study&#xD;
&#xD;
          -  Refuse education/counseling&#xD;
&#xD;
          -  Not knowing Turkish&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <gender_description>Having been diagnosed with breast cancer</gender_description>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Cicek Yagci, Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Istinye University</affiliation>
  </overall_official>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>June 3, 2020</study_first_submitted>
  <study_first_submitted_qc>July 16, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 21, 2020</study_first_posted>
  <last_update_submitted>July 16, 2020</last_update_submitted>
  <last_update_submitted_qc>July 16, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 21, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>telenursing</keyword>
  <keyword>breast cancer</keyword>
  <keyword>chemotherapy</keyword>
  <keyword>symptom management</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Breast Neoplasms</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04480229
org study id: 50687469-1280-2190-14
nct id: NCT04480229
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
This study aims to determine the effectiveness of telenursing services on chemotherapy
      symptoms and comfort levels in patients with breast cancer in Turkey.
This study aims to determine the effectiveness of telenursing services on chemotherapy
      symptoms and comfort levels in patients with breast cancer in Turkey. The study employs an
      experimental research methodology with a sample of 96 ambulatory patients (48 experimental,
      48 control) who were receiving chemotherapy for breast cancer for the first time in a state
      hospital. Research data were collected by using "Patient Information Form", "Edmonton Symptom
      Assessment Scale", "General Comfort Questionnaire, "Symptoms Follow-up Form", and "Telephone
      Call Form". The experimental group received telenursing service every week until the end of
      the four-cycle chemotherapy treatment, which started one week after the first treatment. The
      control group did not receive any intervention. Investigators analyzed data with SPSS 15.0
      (Statistical Package for the Social Sciences) with comparative statistical methods of
      MannWhitney U Test, Chi-Square Test, One Way Analysis of Variance in Repeated Measurements,
      and Pearson Correlation.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: Double (Participant, Investigator)
measure: Edmonton Symptom Assessment System
time frame: 10 minutes
description: This tool is designed to assist in the assessment of symptoms common in cancer patients: pain,fatique, nausea, sadness, anxiety, insomnia, anorexia, wellbeing and shortness of breath, change in skin-nails, mucositis and numbness in hands. The patient circles the most appropriate number to indicate where the symptom is between "0" and "10". "0" is the minimum value, which means there is no change and it is a better outcome for the patient. "10" is the maximum value, means that the symptom level is the highest, which is a worse outcome for the patient.
measure: General Comfort Questionnaire
time frame: 10 minutes
description: It is used to evaluate the situation of achieving the expected comfort increase result with nursing interventions that provide comfort. The scale, which is a four-point likert type, has a total of 48 items, 24 items are positive and 24 items are negative.
The lowest value that can be taken is 1 which indicates low comfort and this is a worse outcome. The highest value 4 indicates high comfort, which is a better outcome. The response patterns of the scale, which consists of positive and negative items, are given in mixed form. Accordingly, from positive statements; high score (4p) indicates high comfort, low score (1p) indicates low comfort, while negative items indicate low comfort (1p), high score (4p) low comfort.
arm group label: Intervention Group
arm group type: Experimental
description: After the first treatment, every week the patients were called and consulted by telenursing. During the next there chemotherapy treatments, Edmonton Symptom Assessment System and General Comfort Questionnaire were filled. The study ended with the fourth cycle chemotherapy. A total of six telephone calls and 3 face-to-face follow-ups were done with each of the intervention group patients. Face-to-face follow-up with patients during chemotherapy treatments lasted for about 20-30 minutes, and patients were evaluated three times in terms of symptom severity and comfort level.
arm group label: No Intervention: Control Group
arm group type: No Intervention
description: During their first treatment the "Patient Identification Form" was filled and they were trained, which is the routine practice of the clinic. Patients were informed about the "Symptom follow-up form", asked to mark the symptoms and signs they experienced due to the disease and treatment in the form between the two chemotherapy treatments and to note when they experienced and how they resolved this symptom. When the patients came to the second treatment, the first follow-up of the patients was done. The investigator filled Edmonton Symptom Assessment System and General Comfort Questionnaire forms via face-to-face interviews. The "Symptom Follow-up Form" given to the patients in the previous chemotherapy treatment was collected and the same new form was given. They were requested to bring this form in their next treatment. The same protocol was followed during the third and fourth chemotherapy treatment
intervention type: Behavioral
intervention name: Telenursing and Counseling
description: After the first face-to-face training, counseling on the phone was conducted every week for four cycles of chemotherapy treatment. In total, six counseling sessions and four face-to-face training sessions were conducted for each patient.
arm group label: Intervention Group
criteria: 
gender: Female
gender based: Yes
gender description: Having been diagnosed with breast cancer
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Cicek Yagci, Ph.D.
role: Principal Investigator
affiliation: Istinye University
responsible party type: Sponsor
mesh term: Breast Neoplasms
sharing ipd: No