<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/NCT02214446</url>
  </required_header>
  <id_info>
    <org_study_id>201311041RINC</org_study_id>
    <nct_id>NCT02214446</nct_id>
  </id_info>
  <brief_title>Factors Related to Truth Telling in Primary Caregivers</brief_title>
  <official_title>Explore Factors Related to Truth Telling in Primary Caregivers of Children Newly Diagnosed With Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>National Taiwan University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>National Taiwan University Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose in this study was to investigate the current status, changes, correlation, and&#xD;
      predictive factors of the truth telling, hope, care burden, and quality of life during&#xD;
      treatment in primary caregivers of newly diagnosed children with cancer.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Background: Over the last 50 years, telling truth in adult with cancer was direct. However,&#xD;
      studies of truth telling in newly diagnosed children with cancer were seldom. Explore the&#xD;
      factors and experiences related to truth telling in primary caregivers of children newly&#xD;
      diagnosis with cancer were seldom too. Therefore, we could not estimate the current status of&#xD;
      truth telling in primary caregivers of newly diagnosed children with cancer.&#xD;
&#xD;
      Purpose: The purpose in this study was to investigate the current status, changes,&#xD;
      correlation, and predictive factors of the truth telling, hope, care burden, and quality of&#xD;
      life during treatment in primary caregivers of newly diagnosed children with cancer.&#xD;
&#xD;
      Method: Purposive sampling structured questionnaire, used longitudinal resistance, repeated&#xD;
      measurements, correlational design. SAS 9.3 for Windows was used for data entry and analyze.&#xD;
      By using the frequency, percentage, mean, and standard deviation to describe demographic&#xD;
      information and current status of truth telling. By using the mean, standard deviation,&#xD;
      maximum and minimum to analyze hope, care burden, and quality of life. Demographic&#xD;
      information, medical information data, truth telling, Herth Hope Index, caregiver burden&#xD;
      scale, and quality of life index were tested by Pearson correlation coefficients; the change&#xD;
      and predictors about truth telling, Herth Hope Index, caregiver burden scale, and quality of&#xD;
      life index were tested by Generalized estimating equation.&#xD;
&#xD;
      Limitation: Studying in one medical center in Taipei, it could not estimate the country's&#xD;
      primary caregivers of newly diagnosed children with cancer in conclusions. Because of the&#xD;
      limitation of the manpower, time and case numbers, study tracked only six month, could not be&#xD;
      assessed the long-term change of the Herth Hope Index, caregiver burden scale, truth telling&#xD;
      and quality of life in primary caregivers of newly diagnosed children with cancer.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>January 2014</start_date>
  <completion_date type="Anticipated">December 2014</completion_date>
  <primary_completion_date type="Anticipated">December 2014</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>primary caregivers' Herth Hope Index</measure>
    <time_frame>Change from baseline at family meeting at 3 months, and at 6 months</time_frame>
    <description>The scores of primary caregivers' Herth Hope Index change from baseline at family meeting at 3 months, and at 6 months.&#xD;
We use Herth Hope Index(HHI) to evaluate the hope that the primary caregivers' care their child during treatment.&#xD;
There are twelve questions in the Herth Hope Index. The total score is from 12 to 48. Cronbach's α is .89. Retest is .80. Two weeks retest is .86.&#xD;
The higher the score is, the greater the hope is.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>primary caregivers' quality of life index</measure>
    <time_frame>Change from baseline at family meeting at 3 months, and at 6 months</time_frame>
    <description>The scores of primary caregivers' quality of life index change from baseline at family meeting at 3 months, and at 6 months.&#xD;
We use quality of life index(Q.L.I) to evaluate the quality of life that the primary caregivers' care their child during treatment.&#xD;
There are 66 questions in the quality of life index. The total score is from 66 to 264. Cronbach's α is .95. Two weeks retest is .87.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>primary caregivers' truth telling</measure>
    <time_frame>Change from baseline at family meeting at 3 months, and at 6 months</time_frame>
    <description>The primary caregivers' truth telling change from baseline at family meeting at 3 months, and at 6 months.&#xD;
Asking the primary caregivers' about that if you tell your child that he/she got the cancer, if you tell your child that he/she the treatment in future, and if you tell your child that he/she the rate of survival.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>primary caregivers' care burden</measure>
    <time_frame>Change from baseline at family meeting at 3 months, and at 6 months</time_frame>
    <description>The scores of primary caregivers' care burden change from baseline at family meeting at 3 months, and at 6 months.&#xD;
We use Questionnaire of care burden to evaluate the care burde that the primary caregivers' care their child during treatment.&#xD;
There are 20 questions in the quality of life index. The total score is from 0 to 60. Cronbach's α is .91.&#xD;
The higher the score is, the heavier the care burden is.</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">84</enrollment>
  <condition>Primary Caregivers of Children Newly Diagnosed With Cancer</condition>
  <arm_group>
    <arm_group_label>primary caregivers of children newly diagnosed with cancer</arm_group_label>
    <description>Explore Factors related to Truth Telling in Primary Caregivers of Children Newly Diagnosed with Cancer</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Primary Caregivers of Children Newly Diagnosed with Cancer&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Primary caregivers of children newly diagnosed with cancer must be aged 20 years or&#xD;
             older.&#xD;
&#xD;
          -  Who can communicate in Chinese and Taiwanese.&#xD;
&#xD;
          -  Consciousness clear.&#xD;
&#xD;
          -  Normal cognitive function.&#xD;
&#xD;
          -  After the explanation, agreed to participate in the study and signed a consent form.&#xD;
&#xD;
          -  The age of children newly diagnosed with cancer is between 0 and 18 years old, who are&#xD;
             newly diagnosed with cancer, before determined treatment plan.&#xD;
&#xD;
          -  The physician of children newly diagnosed with cancer, who were willing to participate&#xD;
             this study and signed a consent form.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Primary caregivers of children newly diagnosed with cancer, who have been diagnosed&#xD;
             mental illness.&#xD;
&#xD;
          -  The children were cancer recurrence.&#xD;
&#xD;
          -  The physician of children newly diagnosed with cancer, who were not willing to&#xD;
             participate this study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>SHIANN-TARNG JOU, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>National Taiwan University Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Chen-Ni Li</last_name>
    <phone>+886-936-806-856</phone>
    <email>jatty7320@hotmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>National Taiwan University Hospital</name>
      <address>
        <city>Taipei</city>
        <country>Taiwan</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>SHIANN-TARNG JOU, PhD</last_name>
      <phone>+886-2-23123456</phone>
      <phone_ext>71716</phone_ext>
      <email>stjou4@gmail.com</email>
    </contact>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <verification_date>August 2014</verification_date>
  <study_first_submitted>December 10, 2013</study_first_submitted>
  <study_first_submitted_qc>August 10, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 12, 2014</study_first_posted>
  <last_update_submitted>August 21, 2014</last_update_submitted>
  <last_update_submitted_qc>August 21, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 22, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>truth telling</keyword>
  <keyword>hope</keyword>
  <keyword>quality of life</keyword>
  <keyword>care burden</keyword>
  <keyword>children with cancer</keyword>
  <!-- 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/NCT02214446
org study id: 201311041RINC
nct id: NCT02214446
lead sponsor: 
has dmc: No
The purpose in this study was to investigate the current status, changes, correlation, and
      predictive factors of the truth telling, hope, care burden, and quality of life during
      treatment in primary caregivers of newly diagnosed children with cancer.
Background: Over the last 50 years, telling truth in adult with cancer was direct. However,
      studies of truth telling in newly diagnosed children with cancer were seldom. Explore the
      factors and experiences related to truth telling in primary caregivers of children newly
      diagnosis with cancer were seldom too. Therefore, we could not estimate the current status of
      truth telling in primary caregivers of newly diagnosed children with cancer.

      Purpose: The purpose in this study was to investigate the current status, changes,
      correlation, and predictive factors of the truth telling, hope, care burden, and quality of
      life during treatment in primary caregivers of newly diagnosed children with cancer.

      Method: Purposive sampling structured questionnaire, used longitudinal resistance, repeated
      measurements, correlational design. SAS 9.3 for Windows was used for data entry and analyze.
      By using the frequency, percentage, mean, and standard deviation to describe demographic
      information and current status of truth telling. By using the mean, standard deviation,
      maximum and minimum to analyze hope, care burden, and quality of life. Demographic
      information, medical information data, truth telling, Herth Hope Index, caregiver burden
      scale, and quality of life index were tested by Pearson correlation coefficients; the change
      and predictors about truth telling, Herth Hope Index, caregiver burden scale, and quality of
      life index were tested by Generalized estimating equation.

      Limitation: Studying in one medical center in Taipei, it could not estimate the country's
      primary caregivers of newly diagnosed children with cancer in conclusions. Because of the
      limitation of the manpower, time and case numbers, study tracked only six month, could not be
      assessed the long-term change of the Herth Hope Index, caregiver burden scale, truth telling
      and quality of life in primary caregivers of newly diagnosed children with cancer.
observational model: Cohort
time perspective: Prospective
measure: primary caregivers' Herth Hope Index
time frame: Change from baseline at family meeting at 3 months, and at 6 months
description: The scores of primary caregivers' Herth Hope Index change from baseline at family meeting at 3 months, and at 6 months.
We use Herth Hope Index(HHI) to evaluate the hope that the primary caregivers' care their child during treatment.
There are twelve questions in the Herth Hope Index. The total score is from 12 to 48. Cronbach's α is .89. Retest is .80. Two weeks retest is .86.
The higher the score is, the greater the hope is.
measure: primary caregivers' quality of life index
time frame: Change from baseline at family meeting at 3 months, and at 6 months
description: The scores of primary caregivers' quality of life index change from baseline at family meeting at 3 months, and at 6 months.
We use quality of life index(Q.L.I) to evaluate the quality of life that the primary caregivers' care their child during treatment.
There are 66 questions in the quality of life index. The total score is from 66 to 264. Cronbach's α is .95. Two weeks retest is .87.
measure: primary caregivers' truth telling
time frame: Change from baseline at family meeting at 3 months, and at 6 months
description: The primary caregivers' truth telling change from baseline at family meeting at 3 months, and at 6 months.
Asking the primary caregivers' about that if you tell your child that he/she got the cancer, if you tell your child that he/she the treatment in future, and if you tell your child that he/she the rate of survival.
measure: primary caregivers' care burden
time frame: Change from baseline at family meeting at 3 months, and at 6 months
description: The scores of primary caregivers' care burden change from baseline at family meeting at 3 months, and at 6 months.
We use Questionnaire of care burden to evaluate the care burde that the primary caregivers' care their child during treatment.
There are 20 questions in the quality of life index. The total score is from 0 to 60. Cronbach's α is .91.
The higher the score is, the heavier the care burden is.
arm group label: primary caregivers of children newly diagnosed with cancer
description: Explore Factors related to Truth Telling in Primary Caregivers of Children Newly Diagnosed with Cancer
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 20 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: SHIANN-TARNG JOU, PhD
role: Principal Investigator
affiliation: National Taiwan University Hospital
last name: Chen-Ni Li
phone: +886-936-806-856
email: jatty7320@hotmail.com
facility: 
status: Recruiting
contact: 
country: Taiwan
responsible party type: Sponsor