<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/NCT03753542</url>
  </required_header>
  <id_info>
    <org_study_id>Enr # 12/2015/912</org_study_id>
    <nct_id>NCT03753542</nct_id>
  </id_info>
  <brief_title>Effect of Nurse-led Education on Parent's Anxiety and Depression on Managing Side Effects of Chemotherapy</brief_title>
  <official_title>Effect of Nurse-led Education on Parent's Anxiety and Depression on Managing Side Effects of Chemotherapy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Nomi Waqas Gul</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Indus Hospital and Health Network</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Dow University of Health Sciences</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      ABSTRACT&#xD;
&#xD;
      Background:&#xD;
&#xD;
      Today, a wide range of pediatric cancers is treated by chemotherapy. More than 21 side&#xD;
      effects of chemotherapy have been identified. Among those nausea; vomiting, infection and&#xD;
      anemia are most common. The adverse effects are normally managed by the parents at home.&#xD;
      Ineffective coping and lack of knowledge about chemotherapy side effect management leads&#xD;
      parents stress. Contemporary research evidence that Nurse-led education, booklet providence&#xD;
      and follow up about chemotherapy and side effect management, help to decrease parents anxiety&#xD;
      and depression.&#xD;
&#xD;
      Objectives:&#xD;
&#xD;
      To measure the effect of nurse-led multimedia education, booklet providence and telephonic&#xD;
      follow up about chemotherapy and side effects management on parents anxiety and depression of&#xD;
      children receiving chemotherapy for the first time.&#xD;
&#xD;
      Methodology:&#xD;
&#xD;
      A randomized control trial will be conducted in the department of chemotherapy at Indus&#xD;
      Children Cancer Hospital Karachi from March 2018 to August 2018 on parents of children below&#xD;
      18 years of age undergoing chemotherapy for the first time. Total 100 parents will be&#xD;
      randomly divided into Intervention group (n=50) and Control Group (n=50). The Intervention&#xD;
      group will received multimedia education, booklet and weekly tele-nursing follow-up about&#xD;
      chemotherapy and side effects management. The Control group will receive routine care.&#xD;
      Parent's anxiety and depression will be identified by using DASS-21 and generalized&#xD;
      estimating estimation will be used to analyzed the data.&#xD;
&#xD;
      Keywords:&#xD;
&#xD;
      Nurse-led, Multimedia education, Booklet, telephonic follow-up, chemotherapy, side effects,&#xD;
      parents, anxiety, depression, children, cancer&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      INTRODUCTION Background Children Cancer in Pakistan: Millions of people are affected by&#xD;
      cancer worldwide. Cancer is one of the major health problems in Pakistan . About 8,000&#xD;
      children below 18 year were diagnosed with cancer annually. Most children diagnosed in&#xD;
      advance stage . In Pakistan 31% children had leukemia, 20% had Lymphoma, 08 % had sarcoma, 8&#xD;
      % had bone tumor, 7% had brain tumor, 6 % had retinoblastoma, 5 % had wilms tumor, 4% had&#xD;
      germ cell tumor, 4 % had neuroblastoma and the other had 7 % .Cancer affects family&#xD;
      emotionally and physically.&#xD;
&#xD;
      Chemotherapy and side effect: Millions of people are also facing difficulties due to&#xD;
      chemotherapy worldwide. If the patient will not prepare for chemotherapy treatment properly&#xD;
      he/she can face problem in future .Chemotherapy is the common method of treatment. The common&#xD;
      side effects of chemotherapy are diarrhea, nausea and vomiting, hair loss, neuropathy, weight&#xD;
      loss, dysphagia, oral ulcer, fatigue, dyspnea, constipation, insomnia and cognitive&#xD;
      impairment, also affects quality of life, economic conditions, emotions and social wellbeing.&#xD;
      Before starting chemotherapy treatment the patient should receive written information about&#xD;
      diagnoses, treatment goal, chemotherapy duration, side effects of drugs, the material should&#xD;
      design at the level of patient knowledge.&#xD;
&#xD;
      Cancer vs anxiety depression: The anxiety is due to unawareness about chemotherapy side&#xD;
      effect. 47% victims of patient have anxiety due to cancer . The power to control disease can&#xD;
      be lost due to anxiety .Side effect of chemotherapy management required self-care and it is&#xD;
      can be effect due to depression. Anxiety and depression has an association with cancer,&#xD;
      chemotherapy related fatigue, lack of education about chemotherapy side effect management and&#xD;
      long term exposure of children in hospital . Cancer treatment required nursing intervention&#xD;
      to reduce anxiety and depression . Anxiety leads to delay chemotherapy treatment and&#xD;
      prognoses.&#xD;
&#xD;
      Evidences of Multimedia education to reduce Anxiety and depression: It is the main&#xD;
      responsibility of Oncology nurse to educate patient about the management of side effect of&#xD;
      chemotherapy but mostly patient received written material only. The recommended practice to&#xD;
      reduce anxiety of patient is to educate about side effect of chemotherapy. The patient should&#xD;
      be education both for short term management and long-term management. Education about side&#xD;
      effect helps to decrease anxiety. The effect of multimedia education to reduce anxiety is&#xD;
      evident in mammography, MRI, ECT, cardiac surgeries, gynecological laparotomy, laparoscopic&#xD;
      cystectomy, hemodialysis, teeth removal and peptic ulcer disease. Nursing intervention&#xD;
      through education helps to reduce anxiety and stress , after chemotherapy, promote side&#xD;
      effect management, decrease complications and increase psychological wellbeing. Many resource&#xD;
      centers for patient education on cancer are available on internet about chemotherapy and side&#xD;
      effect to increase the psychosocial health. The resources can be utilized as a part of&#xD;
      continuous nursing education.&#xD;
&#xD;
      Anxiety and depression in Pakistan: Anxiety and depression is more common in Pakistan due to&#xD;
      lack of infrastructure for mental health services.&#xD;
&#xD;
      Aim of the study: The main aim of this study is to find the effect of nurse let chemotherapy&#xD;
      education on parent's anxiety as in children case parents are the key role for securing among&#xD;
      children cancer. The study will help to examine the effect of psycho-education about&#xD;
      chemotherapy and side effect management on parent's anxiety and depression at Indus children&#xD;
      cancer Hospital, Karachi Pakistan.&#xD;
&#xD;
      Literature Review&#xD;
&#xD;
      International Findings:&#xD;
&#xD;
      European study found that 20 minutes of video education is more effective with verbal and&#xD;
      written education . A randomize control trial was done by Williams and Schreier (2005), on&#xD;
      RCT(N=71), the experimental group (n-38) received audiotaped 20 minutes of education on&#xD;
      management of fatigue, sleep disturbance and anxiety along with standard care and the control&#xD;
      group (n=33) received verbal instruction and written material. The anxiety level was measured&#xD;
      at 1 month and 2 months. Larger number of patient (n=16) in control group reported anxiety as&#xD;
      compared to experimental group (n=10) significantly (p=0.001). Similar result were found from&#xD;
      the study of Malone (2007) that education helps to reduce anxiety. Another study mentioned&#xD;
      that familiarity with environment of chemotherapy is necessary as it also impact on anxiety.&#xD;
      Almost 50% cases diagnosed with cancer reported the symptoms of anxiety. According to NCCN&#xD;
      guideline, the anxiety management related to chemotherapy and side effect management is the&#xD;
      primary responsibility of oncology team including oncology nurse . Study from USA mentioned&#xD;
      that, the caregiver of children diagnosed with cancer have 44% greater stress as compared to&#xD;
      24% parents of healthy children . Another study mentioned that 98% participant were satisfied&#xD;
      with chemotherapy educational experience, 100 % participants mentioned that educational&#xD;
      environment is supportive, 81% feel that quality of life can be improved through education .&#xD;
      Another study mentioned, 87.6% participant were satisfied with chemotherapy education, 87.5 %&#xD;
      agree that it helps to reduce anxiety, 93.3% participant felt that it will be effective if&#xD;
      given first time before chemotherapy, 86.6% participant was satisfied for 30 minutes of&#xD;
      education timing before chemotherapy treatment. 85.7% participant report that quite room&#xD;
      environment is effective for chemotherapy education .In another study mentioned that, 84%&#xD;
      patient report that educational class was help to reduce anxiety and 64.7% participant&#xD;
      disagree for education in group . A randomize control trail was conducted in Greenville and&#xD;
      founded that 23% participant in control group report anxiety after 1 month of treatment as&#xD;
      compared to 14% in interventional group significantly . Written information before&#xD;
      chemotherapy should be provided to patient, the information should include chemotherapy and&#xD;
      side effect, future plan, and follow-up . Many studies had mentioned that that&#xD;
      psycho-education is effective to reduce anxiety during chemotherapy management.&#xD;
&#xD;
      Local findings:&#xD;
&#xD;
      A study from Rawalpindi reported that 10-25% participant reported anxiety and depression&#xD;
      during chemotherapy and 16% have anxiety and 27% have depression . Another study mentioned&#xD;
      that myeloid leukemia is commonly diagnosed in younger age but mostly reported in chronic&#xD;
      phase . A study from Lahore mentioned that 56% parents have depression, higher in mothers&#xD;
      specially those who are low educated and had poor socio-economical class. A study from&#xD;
      Karachi mentioned caregiver stress related to cancer patient s, 17% mild, 34% moderate and 49&#xD;
      % severe stress. It was also conclude that caregiver stress for cancer patient had&#xD;
      significant association with caregiver age, relationship with child , female gender and&#xD;
      longer duration of care.&#xD;
&#xD;
      Statement of Problem Children cannot look after themselves. Parents are the primary caregiver&#xD;
      of children. If they initially feel anxiety and depression, it will be difficult for them to&#xD;
      manage chemotherapy and side effects. Education about chemotherapy is neglected due to heavy&#xD;
      workload and other responsibilities. More than 50% of individual newly diagnosed with cancer&#xD;
      have unknown anxiety related to chemotherapy and their side effect . Those who do not receive&#xD;
      chemotherapy education prior to treatment face difficulties in later life . The side effects&#xD;
      of chemotherapy like vomiting, nausea, loss of appetite and fatigue were managed through&#xD;
      self-care . After an intensive literature review it was found that no study was conducted in&#xD;
      Pakistan focusing effect of nurse-led multimedia education and telephonic follow up, on&#xD;
      chemotherapy side effects management for parent's anxiety and depression.&#xD;
&#xD;
      Rationale of Study Pediatric cancer is the leading cause of children mortality and morbidity&#xD;
      in Pakistan. More than 8,000 children under 18 year of age were diagnosed with cancer in a&#xD;
      year. Cancer treatment were managed by the parents specially mother. Evidences showed lack of&#xD;
      knowledge about chemotherapy and dissatisfaction of the information about what they have&#xD;
      received, leads uncertainty, apprehension and delay continuation with chemotherapy treatment.&#xD;
      Many organization developed booklet for patient education about chemotherapy and side effect&#xD;
      management. They also have provided online resources. The patient read information at their&#xD;
      own efforts. Multimedia education and Tele- nursing follow up was found cost effective method&#xD;
      to reduce family anxiety in many countries . Parent's anxiety and depression leads poor&#xD;
      management of cancer treatment for their child. Literature evidence that Nurse led&#xD;
      psycho-education through multimedia education telephonic follows up is cost effective method&#xD;
      to reduce anxiety and depression related to treatment process. According to senior oncologist&#xD;
      Pakistan, Parents are anxious not only about Chemo side-effect but also about disease itself.&#xD;
      Most parents have same knowledge of side effects of chemotherapy because of their experiences&#xD;
      with friend's relatives who have undergo to course treatment. Secondly, side effect is&#xD;
      mentioned at first counseling session by primarily oncologist.&#xD;
&#xD;
      Objectives To measure the effect of nurse-led multimedia education, booklet providence and&#xD;
      telephonic follow up about chemotherapy and side effects management on parent's anxiety and&#xD;
      depression of children receiving chemotherapy for the first time.&#xD;
&#xD;
      Operational Definitions Nurse-Led: Any intervention given by the nurses under professional&#xD;
      guidelines. Multimedia education: Education given by using PowerPoint presentation or by&#xD;
      using multimedia projector.&#xD;
&#xD;
      Telephonic Follow up: The continuation of educational process by using Tele-communication.&#xD;
&#xD;
      Chemotherapy side effect: The adverse effects of chemotherapy other than therapeutic effect.&#xD;
&#xD;
      Parent's anxiety and depression: Feelings of concern, uneasiness, nervousness and sadness of&#xD;
      parents related to child, diagnosed with cancer and undergoing for chemotherapy first time.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 6, 2018</start_date>
  <completion_date type="Actual">June 15, 2019</completion_date>
  <primary_completion_date type="Actual">December 30, 2018</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>Prevention</primary_purpose>
    <masking>Single (Care Provider)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Depression, Anxiety and Stress Scale - 21 (DASS-21)</measure>
    <time_frame>up to 4 weeks</time_frame>
    <description>DASS-21 is comprised of questionnaires for three separate scales measuring Depression, Anxiety and Stress. The depression scale is scored by summing the responses of each question, multiplying by 2 and then scoring on a scale ranging from a minimum of 0 to a maximum of 28+, with higher scores indicating greater severity. The anxiety scale is scored by summing the responses of each question, multiplying by 2 and then scoring on a scale ranging from a minimum of 0 to a maximum of 20+, with higher scores indicating greater severity. The stress scale is scored by summing the responses of each question, multiplying by 2 and then scoring on a scale ranging from a minimum of 0 to a maximum of 37+, with higher scores indicating greater severity</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">100</enrollment>
  <condition>Chemotherapy Effect</condition>
  <arm_group>
    <arm_group_label>Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The Intervention group will received multimedia education, booklet and weekly tele-nursing follow-up about chemotherapy and side effects management</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>The Control group will receive routine care</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Multimedia education, booklet Providence and tele-nursing follow-up</intervention_name>
    <description>Multimedia education, booklet and weekly tele-nursing follow-up is about chemotherapy and side effects management</description>
    <arm_group_label>Intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Parents along with their Children younger than 18 years of age Note: (Here Child age&#xD;
             was taken as Inclusion criteria for Parents, because child age is evident for impact&#xD;
             on Parents Psychology, in local study no association of Parents age was evident)&#xD;
&#xD;
          2. Parents along with their children newly diagnosed with cancer in last three weeks&#xD;
&#xD;
          3. Parents along with their children schedule to receive first time chemotherapy in the&#xD;
             outpatient department&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Parents along with their children refused to participate&#xD;
&#xD;
          2. Parents along with their children already receiving interventions like multimedia&#xD;
             education, booklet providence and telephonic follow up for chemotherapy and side&#xD;
             effect management&#xD;
&#xD;
          3. Parents taking medicine for their anxiety and depression. (e.g. Anxiolytics/&#xD;
             Antidepressant)&#xD;
&#xD;
          4. Parents showing uneasiness and discomfort during educational session.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>18 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Dr. Mehwish HUSSAIN, PhD (Statistics)</last_name>
    <role>Study Chair</role>
    <affiliation>Assistant Professor, DUHS, Karachi</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Dr. SHAMVIL ASHRAF, MBBS, DCH, MCPS, FCPS, MRCP</last_name>
    <role>Study Chair</role>
    <affiliation>Indus Hospital Karachi</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Mr. Hakim Shah, MSN</last_name>
    <role>Study Chair</role>
    <affiliation>Associate Professor Institute of Nursing Dow University of Health Sciences Karachi</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Indus Children Cancer Hospital Karachi</name>
      <address>
        <city>Karachi</city>
        <state>Sindh</state>
        <country>Pakistan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Pakistan</country>
  </location_countries>
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  <verification_date>July 2022</verification_date>
  <study_first_submitted>November 16, 2018</study_first_submitted>
  <study_first_submitted_qc>November 22, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 27, 2018</study_first_posted>
  <results_first_submitted>August 6, 2019</results_first_submitted>
  <results_first_submitted_qc>July 27, 2022</results_first_submitted_qc>
  <results_first_posted type="Actual">July 28, 2022</results_first_posted>
  <last_update_submitted>July 27, 2022</last_update_submitted>
  <last_update_submitted_qc>July 27, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">July 28, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Dow University of Health Sciences</investigator_affiliation>
    <investigator_full_name>Nomi Waqas Gul</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>chemotherapy, side effects, parents, anxiety, depression</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Depression</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>No plan</ipd_description>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>June 30, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/42/NCT03753542/Prot_SAP_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Informed Consent Form</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>March 1, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/42/NCT03753542/ICF_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>The parents along with children were recruited in the study from September 2018 to November 2018 and follow up were continued from October 2018 to December 2018. After the completion of follow up to 5th December 2018 the trail was ended due to the completion of target sample sized (N=100) of parents and follow up schedule.The age of children were taken as associated factor for parent as study evident that children age has impact on parents anxiety. Parent age was not taken due to guardian issue.</recruitment_details>
      <pre_assignment_details>Total 100 parents were randomly divided into Intervention group (n=50) and Control Group (n=50). After excluding lost to follow up, the data was analyzed from 77 sample of parents (41 in intervention group and 36 in control group). The intervention group received multimedia education, booklet and weekly tele-nursing follow-up about chemotherapy and side effects management. The control group received routine care.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Intervention</title>
          <description>The Intervention group received multimedia education, booklet and weekly tele-nursing follow-up about chemotherapy and side effects management</description>
        </group>
        <group group_id="P2">
          <title>Control</title>
          <description>The Control group receive routine care</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="50">Actual Calculated Sample size was 30 Sample, 100 was taken to restore lost to follow up</participants>
                <participants group_id="P2" count="50">Actual Calculated Sample size was 30 Sample, 100 was taken to restore lost to follow up</participants>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="41">In spite of having lost to follow up the power of study was not lost</participants>
                <participants group_id="P2" count="36">In spite of having lost to follow up the power of study was not lost</participants>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="9"/>
                <participants group_id="P2" count="14"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="9"/>
                <participants group_id="P2" count="14"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>After excluding lost to follow up total data analyse in intervention group was 41 and control group was 36</population>
      <group_list>
        <group group_id="B1">
          <title>Intervention</title>
          <description>The Intervention group will received multimedia education, booklet and weekly tele-nursing follow-up about chemotherapy and side effects management&#xD;
Multimedia education, booklet Providence and tele-nursing follow-up: Multimedia education, booklet and weekly tele-nursing follow-up is about chemotherapy and side effects management</description>
        </group>
        <group group_id="B2">
          <title>Control</title>
          <description>The Control group will receive routine care</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="41"/>
            <count group_id="B2" value="36"/>
            <count group_id="B3" value="77"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age, Customized</title>
          <description>Note: In this study age of children were taken as associated factor for parents anxiety, depression and stress because local studies evident that age of children were associated with parent psychology. The age of parent were not assess due to guardian issues. It is recommended, other student should also take the age of parents. As the age of parents was not taken hence it may be considered as limitations in this study.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>1. Child Age:</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="41"/>
                    <count group_id="B2" value="36"/>
                    <count group_id="B3" value="77"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>2-4years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="13"/>
                    <measurement group_id="B2" value="11"/>
                    <measurement group_id="B3" value="24"/>
                  </measurement_list>
                </category>
                <category>
                  <title>5-7years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="18"/>
                  </measurement_list>
                </category>
                <category>
                  <title>8-12 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="12"/>
                    <measurement group_id="B2" value="12"/>
                    <measurement group_id="B3" value="24"/>
                  </measurement_list>
                </category>
                <category>
                  <title>13-18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex/Gender, Customized</title>
          <description>In this study Gender of the children were assessed instead gender of the parents, because gender discrimination e.g Male child Vs Female child is common at local level. Gender of children has psychological effect on parents. e.g. Male children support family while female not. This type of thinking is common in Poor socioeconomic situation. Gender of parents were not taken due to guardian issues. Other studies are recommended to take gender of the parent as associative factors.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>2. Child Gender:</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="41"/>
                    <count group_id="B2" value="36"/>
                    <count group_id="B3" value="77"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="24"/>
                    <measurement group_id="B2" value="26"/>
                    <measurement group_id="B3" value="50"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="17"/>
                    <measurement group_id="B2" value="10"/>
                    <measurement group_id="B3" value="27"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race and Ethnicity Not Collected</title>
          <population>Race and Ethnicity were not collected from any participant.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="0"/>
                    <count group_id="B2" value="0"/>
                    <count group_id="B3" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>3. Primary Care Giver:</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="41"/>
                    <count group_id="B2" value="36"/>
                    <count group_id="B3" value="77"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Mother/Father</title>
                  <measurement_list>
                    <measurement group_id="B1" value="38"/>
                    <measurement group_id="B2" value="30"/>
                    <measurement group_id="B3" value="68"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Others</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>4. Residency/Locality:</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="41"/>
                    <count group_id="B2" value="36"/>
                    <count group_id="B3" value="77"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Local</title>
                  <measurement_list>
                    <measurement group_id="B1" value="17"/>
                    <measurement group_id="B2" value="11"/>
                    <measurement group_id="B3" value="28"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Non- Local</title>
                  <measurement_list>
                    <measurement group_id="B1" value="24"/>
                    <measurement group_id="B2" value="25"/>
                    <measurement group_id="B3" value="49"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>5. Occupation</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="41"/>
                    <count group_id="B2" value="36"/>
                    <count group_id="B3" value="77"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Labor</title>
                  <measurement_list>
                    <measurement group_id="B1" value="24"/>
                    <measurement group_id="B2" value="18"/>
                    <measurement group_id="B3" value="42"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Shopkeeper</title>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                    <measurement group_id="B2" value="9"/>
                    <measurement group_id="B3" value="17"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Other</title>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                    <measurement group_id="B2" value="9"/>
                    <measurement group_id="B3" value="18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>6. Level of education</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="41"/>
                    <count group_id="B2" value="36"/>
                    <count group_id="B3" value="77"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Uneducated</title>
                  <measurement_list>
                    <measurement group_id="B1" value="11"/>
                    <measurement group_id="B2" value="11"/>
                    <measurement group_id="B3" value="22"/>
                  </measurement_list>
                </category>
                <category>
                  <title>School Education</title>
                  <measurement_list>
                    <measurement group_id="B1" value="17"/>
                    <measurement group_id="B2" value="16"/>
                    <measurement group_id="B3" value="33"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Higher Education</title>
                  <measurement_list>
                    <measurement group_id="B1" value="13"/>
                    <measurement group_id="B2" value="9"/>
                    <measurement group_id="B3" value="22"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>7. Employment status</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="41"/>
                    <count group_id="B2" value="36"/>
                    <count group_id="B3" value="77"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Daily Wages</title>
                  <measurement_list>
                    <measurement group_id="B1" value="28"/>
                    <measurement group_id="B2" value="21"/>
                    <measurement group_id="B3" value="49"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Monthly Salary</title>
                  <measurement_list>
                    <measurement group_id="B1" value="13"/>
                    <measurement group_id="B2" value="15"/>
                    <measurement group_id="B3" value="28"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>8. Income per month (Rupees)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="41"/>
                    <count group_id="B2" value="36"/>
                    <count group_id="B3" value="77"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>less than 10,000</title>
                  <measurement_list>
                    <measurement group_id="B1" value="12"/>
                    <measurement group_id="B2" value="17"/>
                    <measurement group_id="B3" value="29"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than 10,000</title>
                  <measurement_list>
                    <measurement group_id="B1" value="29"/>
                    <measurement group_id="B2" value="19"/>
                    <measurement group_id="B3" value="48"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>9 Child Diagnoses</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="41"/>
                    <count group_id="B2" value="36"/>
                    <count group_id="B3" value="77"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Leukemia</title>
                  <measurement_list>
                    <measurement group_id="B1" value="28"/>
                    <measurement group_id="B2" value="23"/>
                    <measurement group_id="B3" value="51"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Other</title>
                  <measurement_list>
                    <measurement group_id="B1" value="13"/>
                    <measurement group_id="B2" value="13"/>
                    <measurement group_id="B3" value="26"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>10. Family History of cancer</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="41"/>
                    <count group_id="B2" value="36"/>
                    <count group_id="B3" value="77"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>No</title>
                  <measurement_list>
                    <measurement group_id="B1" value="34"/>
                    <measurement group_id="B2" value="33"/>
                    <measurement group_id="B3" value="67"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Yes</title>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>11. Pain felt by the child</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="41"/>
                    <count group_id="B2" value="36"/>
                    <count group_id="B3" value="77"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>No</title>
                  <measurement_list>
                    <measurement group_id="B1" value="23"/>
                    <measurement group_id="B2" value="26"/>
                    <measurement group_id="B3" value="49"/>
                  </measurement_list>
                </category>
                <category>
                  <title>yes</title>
                  <measurement_list>
                    <measurement group_id="B1" value="18"/>
                    <measurement group_id="B2" value="10"/>
                    <measurement group_id="B3" value="28"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>12. Do parent have smoking habits?</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="41"/>
                    <count group_id="B2" value="36"/>
                    <count group_id="B3" value="77"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>No</title>
                  <measurement_list>
                    <measurement group_id="B1" value="21"/>
                    <measurement group_id="B2" value="23"/>
                    <measurement group_id="B3" value="44"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Yes</title>
                  <measurement_list>
                    <measurement group_id="B1" value="20"/>
                    <measurement group_id="B2" value="13"/>
                    <measurement group_id="B3" value="33"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Depression</title>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="41"/>
                    <count group_id="B2" value="36"/>
                    <count group_id="B3" value="77"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="15.41" spread="5.97"/>
                    <measurement group_id="B2" value="16.28" spread="7.32"/>
                    <measurement group_id="B3" value="15.82" spread="6.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Anxiety</title>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="41"/>
                    <count group_id="B2" value="36"/>
                    <count group_id="B3" value="77"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="11.9" spread="6.51"/>
                    <measurement group_id="B2" value="10.72" spread="7"/>
                    <measurement group_id="B3" value="11.35" spread="6.72"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Stress</title>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="41"/>
                    <count group_id="B2" value="36"/>
                    <count group_id="B3" value="77"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="16.63" spread="5.96"/>
                    <measurement group_id="B2" value="16.67" spread="6.45"/>
                    <measurement group_id="B3" value="16.65" spread="6.15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Depression, Anxiety and Stress Scale - 21 (DASS-21)</title>
        <description>DASS-21 is comprised of questionnaires for three separate scales measuring Depression, Anxiety and Stress. The depression scale is scored by summing the responses of each question, multiplying by 2 and then scoring on a scale ranging from a minimum of 0 to a maximum of 28+, with higher scores indicating greater severity. The anxiety scale is scored by summing the responses of each question, multiplying by 2 and then scoring on a scale ranging from a minimum of 0 to a maximum of 20+, with higher scores indicating greater severity. The stress scale is scored by summing the responses of each question, multiplying by 2 and then scoring on a scale ranging from a minimum of 0 to a maximum of 37+, with higher scores indicating greater severity</description>
        <time_frame>up to 4 weeks</time_frame>
        <population>Total 100 parents were enrolled and randomly allocated to (i)intervention group and (ii)Control group with equal number of allocations in each group respectively. The data were analyzed after excluding lost to follow up variables.</population>
        <group_list>
          <group group_id="O1">
            <title>Intervention</title>
            <description>The Intervention group received multimedia education, booklet and weekly tele-nursing follow-up about chemotherapy and side effects management</description>
          </group>
          <group group_id="O2">
            <title>Control</title>
            <description>The Control group will receive routine follow up.</description>
          </group>
        </group_list>
        <measure>
          <title>Depression, Anxiety and Stress Scale - 21 (DASS-21)</title>
          <description>DASS-21 is comprised of questionnaires for three separate scales measuring Depression, Anxiety and Stress. The depression scale is scored by summing the responses of each question, multiplying by 2 and then scoring on a scale ranging from a minimum of 0 to a maximum of 28+, with higher scores indicating greater severity. The anxiety scale is scored by summing the responses of each question, multiplying by 2 and then scoring on a scale ranging from a minimum of 0 to a maximum of 20+, with higher scores indicating greater severity. The stress scale is scored by summing the responses of each question, multiplying by 2 and then scoring on a scale ranging from a minimum of 0 to a maximum of 37+, with higher scores indicating greater severity</description>
          <population>Total 100 parents were enrolled and randomly allocated to (i)intervention group and (ii)Control group with equal number of allocations in each group respectively. The data were analyzed after excluding lost to follow up variables.</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="41"/>
                <count group_id="O2" value="36"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Post-Depression (After 1 week)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.44" spread="3.94"/>
                    <measurement group_id="O2" value="9.72" spread="5.82"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Two- Week Post Depression (After 2 week)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.63" spread="2.98"/>
                    <measurement group_id="O2" value="6.11" spread="4.94"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Post-Anxiety (After 1 week)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.2" spread="3.43"/>
                    <measurement group_id="O2" value="6.61" spread="5.23"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Two- Week Post Anxiety (After 2 week)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.75" spread="2.33"/>
                    <measurement group_id="O2" value="4.27" spread="3.61"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Post-Stress (After 1 week)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.02" spread="4.59"/>
                    <measurement group_id="O2" value="11" spread="6.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Two- Week Post Stress (After 2 week)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.88" spread="3.1"/>
                    <measurement group_id="O2" value="6.83" spread="5.22"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>2 months</time_frame>
      <desc>The intervention were limited to Parents education only. . The education was given under international guideline of NIH. Hence, Adverse Events were not monitored/assessed/ nor reported by participant.</desc>
      <group_list>
        <group group_id="E1">
          <title>Intervention</title>
          <description>No Adverse event reported</description>
        </group>
        <group group_id="E2">
          <title>Control</title>
          <description>No Adverse event reported</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="0"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="0"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <limitations_and_caveats>As the study was conducted in single setting, hence the result may not be generalized. Further studies are recommended to measure its general effect.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Nomi Waqas Gul, Student MSN DUHS ION and Asst. Controller Sindh Nurses Examination Board, Karachi</name_or_title>
      <organization>Institute of Nursing Dow University of Health Sciences, Karachi/Sindh Nurses Examination Board, Karachi</organization>
      <phone>0345-2506790</phone>
      <email>nomiwg@gmail.com</email>
    </point_of_contact>
  </clinical_results>
</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/NCT03753542
org study id: Enr # 12/2015/912
nct id: NCT03753542
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
ABSTRACT

      Background:

      Today, a wide range of pediatric cancers is treated by chemotherapy. More than 21 side
      effects of chemotherapy have been identified. Among those nausea; vomiting, infection and
      anemia are most common. The adverse effects are normally managed by the parents at home.
      Ineffective coping and lack of knowledge about chemotherapy side effect management leads
      parents stress. Contemporary research evidence that Nurse-led education, booklet providence
      and follow up about chemotherapy and side effect management, help to decrease parents anxiety
      and depression.

      Objectives:

      To measure the effect of nurse-led multimedia education, booklet providence and telephonic
      follow up about chemotherapy and side effects management on parents anxiety and depression of
      children receiving chemotherapy for the first time.

      Methodology:

      A randomized control trial will be conducted in the department of chemotherapy at Indus
      Children Cancer Hospital Karachi from March 2018 to August 2018 on parents of children below
      18 years of age undergoing chemotherapy for the first time. Total 100 parents will be
      randomly divided into Intervention group (n=50) and Control Group (n=50). The Intervention
      group will received multimedia education, booklet and weekly tele-nursing follow-up about
      chemotherapy and side effects management. The Control group will receive routine care.
      Parent's anxiety and depression will be identified by using DASS-21 and generalized
      estimating estimation will be used to analyzed the data.

      Keywords:

      Nurse-led, Multimedia education, Booklet, telephonic follow-up, chemotherapy, side effects,
      parents, anxiety, depression, children, cancer
INTRODUCTION Background Children Cancer in Pakistan: Millions of people are affected by
      cancer worldwide. Cancer is one of the major health problems in Pakistan . About 8,000
      children below 18 year were diagnosed with cancer annually. Most children diagnosed in
      advance stage . In Pakistan 31% children had leukemia, 20% had Lymphoma, 08 % had sarcoma, 8
      % had bone tumor, 7% had brain tumor, 6 % had retinoblastoma, 5 % had wilms tumor, 4% had
      germ cell tumor, 4 % had neuroblastoma and the other had 7 % .Cancer affects family
      emotionally and physically.

      Chemotherapy and side effect: Millions of people are also facing difficulties due to
      chemotherapy worldwide. If the patient will not prepare for chemotherapy treatment properly
      he/she can face problem in future .Chemotherapy is the common method of treatment. The common
      side effects of chemotherapy are diarrhea, nausea and vomiting, hair loss, neuropathy, weight
      loss, dysphagia, oral ulcer, fatigue, dyspnea, constipation, insomnia and cognitive
      impairment, also affects quality of life, economic conditions, emotions and social wellbeing.
      Before starting chemotherapy treatment the patient should receive written information about
      diagnoses, treatment goal, chemotherapy duration, side effects of drugs, the material should
      design at the level of patient knowledge.

      Cancer vs anxiety depression: The anxiety is due to unawareness about chemotherapy side
      effect. 47% victims of patient have anxiety due to cancer . The power to control disease can
      be lost due to anxiety .Side effect of chemotherapy management required self-care and it is
      can be effect due to depression. Anxiety and depression has an association with cancer,
      chemotherapy related fatigue, lack of education about chemotherapy side effect management and
      long term exposure of children in hospital . Cancer treatment required nursing intervention
      to reduce anxiety and depression . Anxiety leads to delay chemotherapy treatment and
      prognoses.

      Evidences of Multimedia education to reduce Anxiety and depression: It is the main
      responsibility of Oncology nurse to educate patient about the management of side effect of
      chemotherapy but mostly patient received written material only. The recommended practice to
      reduce anxiety of patient is to educate about side effect of chemotherapy. The patient should
      be education both for short term management and long-term management. Education about side
      effect helps to decrease anxiety. The effect of multimedia education to reduce anxiety is
      evident in mammography, MRI, ECT, cardiac surgeries, gynecological laparotomy, laparoscopic
      cystectomy, hemodialysis, teeth removal and peptic ulcer disease. Nursing intervention
      through education helps to reduce anxiety and stress , after chemotherapy, promote side
      effect management, decrease complications and increase psychological wellbeing. Many resource
      centers for patient education on cancer are available on internet about chemotherapy and side
      effect to increase the psychosocial health. The resources can be utilized as a part of
      continuous nursing education.

      Anxiety and depression in Pakistan: Anxiety and depression is more common in Pakistan due to
      lack of infrastructure for mental health services.

      Aim of the study: The main aim of this study is to find the effect of nurse let chemotherapy
      education on parent's anxiety as in children case parents are the key role for securing among
      children cancer. The study will help to examine the effect of psycho-education about
      chemotherapy and side effect management on parent's anxiety and depression at Indus children
      cancer Hospital, Karachi Pakistan.

      Literature Review

      International Findings:

      European study found that 20 minutes of video education is more effective with verbal and
      written education . A randomize control trial was done by Williams and Schreier (2005), on
      RCT(N=71), the experimental group (n-38) received audiotaped 20 minutes of education on
      management of fatigue, sleep disturbance and anxiety along with standard care and the control
      group (n=33) received verbal instruction and written material. The anxiety level was measured
      at 1 month and 2 months. Larger number of patient (n=16) in control group reported anxiety as
      compared to experimental group (n=10) significantly (p=0.001). Similar result were found from
      the study of Malone (2007) that education helps to reduce anxiety. Another study mentioned
      that familiarity with environment of chemotherapy is necessary as it also impact on anxiety.
      Almost 50% cases diagnosed with cancer reported the symptoms of anxiety. According to NCCN
      guideline, the anxiety management related to chemotherapy and side effect management is the
      primary responsibility of oncology team including oncology nurse . Study from USA mentioned
      that, the caregiver of children diagnosed with cancer have 44% greater stress as compared to
      24% parents of healthy children . Another study mentioned that 98% participant were satisfied
      with chemotherapy educational experience, 100 % participants mentioned that educational
      environment is supportive, 81% feel that quality of life can be improved through education .
      Another study mentioned, 87.6% participant were satisfied with chemotherapy education, 87.5 %
      agree that it helps to reduce anxiety, 93.3% participant felt that it will be effective if
      given first time before chemotherapy, 86.6% participant was satisfied for 30 minutes of
      education timing before chemotherapy treatment. 85.7% participant report that quite room
      environment is effective for chemotherapy education .In another study mentioned that, 84%
      patient report that educational class was help to reduce anxiety and 64.7% participant
      disagree for education in group . A randomize control trail was conducted in Greenville and
      founded that 23% participant in control group report anxiety after 1 month of treatment as
      compared to 14% in interventional group significantly . Written information before
      chemotherapy should be provided to patient, the information should include chemotherapy and
      side effect, future plan, and follow-up . Many studies had mentioned that that
      psycho-education is effective to reduce anxiety during chemotherapy management.

      Local findings:

      A study from Rawalpindi reported that 10-25% participant reported anxiety and depression
      during chemotherapy and 16% have anxiety and 27% have depression . Another study mentioned
      that myeloid leukemia is commonly diagnosed in younger age but mostly reported in chronic
      phase . A study from Lahore mentioned that 56% parents have depression, higher in mothers
      specially those who are low educated and had poor socio-economical class. A study from
      Karachi mentioned caregiver stress related to cancer patient s, 17% mild, 34% moderate and 49
      % severe stress. It was also conclude that caregiver stress for cancer patient had
      significant association with caregiver age, relationship with child , female gender and
      longer duration of care.

      Statement of Problem Children cannot look after themselves. Parents are the primary caregiver
      of children. If they initially feel anxiety and depression, it will be difficult for them to
      manage chemotherapy and side effects. Education about chemotherapy is neglected due to heavy
      workload and other responsibilities. More than 50% of individual newly diagnosed with cancer
      have unknown anxiety related to chemotherapy and their side effect . Those who do not receive
      chemotherapy education prior to treatment face difficulties in later life . The side effects
      of chemotherapy like vomiting, nausea, loss of appetite and fatigue were managed through
      self-care . After an intensive literature review it was found that no study was conducted in
      Pakistan focusing effect of nurse-led multimedia education and telephonic follow up, on
      chemotherapy side effects management for parent's anxiety and depression.

      Rationale of Study Pediatric cancer is the leading cause of children mortality and morbidity
      in Pakistan. More than 8,000 children under 18 year of age were diagnosed with cancer in a
      year. Cancer treatment were managed by the parents specially mother. Evidences showed lack of
      knowledge about chemotherapy and dissatisfaction of the information about what they have
      received, leads uncertainty, apprehension and delay continuation with chemotherapy treatment.
      Many organization developed booklet for patient education about chemotherapy and side effect
      management. They also have provided online resources. The patient read information at their
      own efforts. Multimedia education and Tele- nursing follow up was found cost effective method
      to reduce family anxiety in many countries . Parent's anxiety and depression leads poor
      management of cancer treatment for their child. Literature evidence that Nurse led
      psycho-education through multimedia education telephonic follows up is cost effective method
      to reduce anxiety and depression related to treatment process. According to senior oncologist
      Pakistan, Parents are anxious not only about Chemo side-effect but also about disease itself.
      Most parents have same knowledge of side effects of chemotherapy because of their experiences
      with friend's relatives who have undergo to course treatment. Secondly, side effect is
      mentioned at first counseling session by primarily oncologist.

      Objectives To measure the effect of nurse-led multimedia education, booklet providence and
      telephonic follow up about chemotherapy and side effects management on parent's anxiety and
      depression of children receiving chemotherapy for the first time.

      Operational Definitions Nurse-Led: Any intervention given by the nurses under professional
      guidelines. Multimedia education: Education given by using PowerPoint presentation or by
      using multimedia projector.

      Telephonic Follow up: The continuation of educational process by using Tele-communication.

      Chemotherapy side effect: The adverse effects of chemotherapy other than therapeutic effect.

      Parent's anxiety and depression: Feelings of concern, uneasiness, nervousness and sadness of
      parents related to child, diagnosed with cancer and undergoing for chemotherapy first time.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Single (Care Provider)
measure: Depression, Anxiety and Stress Scale - 21 (DASS-21)
time frame: up to 4 weeks
description: DASS-21 is comprised of questionnaires for three separate scales measuring Depression, Anxiety and Stress. The depression scale is scored by summing the responses of each question, multiplying by 2 and then scoring on a scale ranging from a minimum of 0 to a maximum of 28+, with higher scores indicating greater severity. The anxiety scale is scored by summing the responses of each question, multiplying by 2 and then scoring on a scale ranging from a minimum of 0 to a maximum of 20+, with higher scores indicating greater severity. The stress scale is scored by summing the responses of each question, multiplying by 2 and then scoring on a scale ranging from a minimum of 0 to a maximum of 37+, with higher scores indicating greater severity
arm group label: Intervention
arm group type: Experimental
description: The Intervention group will received multimedia education, booklet and weekly tele-nursing follow-up about chemotherapy and side effects management
arm group label: Control
arm group type: No Intervention
description: The Control group will receive routine care
intervention type: Other
intervention name: Multimedia education, booklet Providence and tele-nursing follow-up
description: Multimedia education, booklet and weekly tele-nursing follow-up is about chemotherapy and side effects management
arm group label: Intervention
criteria: 
gender: All
minimum age: N/A
maximum age: 18 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Dr. Mehwish HUSSAIN, PhD (Statistics)
role: Study Chair
affiliation: Assistant Professor, DUHS, Karachi
last name: Dr. SHAMVIL ASHRAF, MBBS, DCH, MCPS, FCPS, MRCP
role: Study Chair
affiliation: Indus Hospital Karachi
last name: Mr. Hakim Shah, MSN
role: Study Chair
affiliation: Associate Professor Institute of Nursing Dow University of Health Sciences Karachi
facility: 
country: Pakistan
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responsible party type: Sponsor-Investigator
investigator affiliation: Dow University of Health Sciences
investigator full name: Nomi Waqas Gul
investigator title: Principal Investigator
mesh term: Depression
sharing ipd: No
ipd description: No plan
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: As the study was conducted in single setting, hence the result may not be generalized. Further studies are recommended to measure its general effect.
point of contact: 