<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/NCT03298971</url>
  </required_header>
  <id_info>
    <org_study_id>UW 17-331</org_study_id>
    <nct_id>NCT03298971</nct_id>
  </id_info>
  <brief_title>The Impact of Cancer on the Physical and Psychosocial Well-being Among Childhood Osteosarcoma Survivors</brief_title>
  <official_title>The Impact of Cancer and Treatment-related Effects on the Physical and Psychosocial Well-being and Quality of Life Among Hong Kong Chinese Survivors of Childhood Osteosarcoma: An Exploratory Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The University of Hong Kong</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>The University of Hong Kong</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>
      The aim of the study is to examine the impact of cancer and treatment-related effects on the&#xD;
      physical and psychosocial well-being and quality of life among Hong Kong Chinese survivors of&#xD;
      childhood osteosarcoma.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Osteosarcoma is the most common primary malignant bone tumor in children and adolescents. The&#xD;
      5-year overall survival rates of childhood osteosarcoma survivors have been increasing&#xD;
      substantially with a percentage approaching to 70%. Regrettably, the improved survival rates&#xD;
      may lead to long-term sequelae related to disease and treatments that can negatively affect&#xD;
      survivors' physical and psychological well-being. Despite numerous studies have examined the&#xD;
      impact of cancer and treatment-related late effects on the physical and psychological aspects&#xD;
      of osteosarcoma survivors in the foreign countries, it has not been studied specifically in&#xD;
      Hong Kong Chinese population. Problems arise when there is a difference in perception and&#xD;
      recognition of psychological problems and emotional well-being between Western and Chinese&#xD;
      culture. Moreover, the difference in coping strategies between Chinese and Western children&#xD;
      also affects how they react and cope with the devastating effect from cancer and its&#xD;
      treatments. Due to the cultural and belief differences, the findings from those studies in&#xD;
      the foreign counties may not be applicable and transferable in Hong Kong context. There is&#xD;
      thus an imperative need to investigate the impact of cancer and treatment-related effects on&#xD;
      the physical and psychosocial well-being and quality of life among Hong Kong Chinese&#xD;
      survivors of childhood osteosarcoma in order to raise awareness of the holistic wellness of&#xD;
      osteosarcoma survivors.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">September 8, 2017</start_date>
  <completion_date type="Anticipated">December 1, 2022</completion_date>
  <primary_completion_date type="Anticipated">December 1, 2022</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>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Levels of quality of life at baseline</measure>
    <time_frame>baseline</time_frame>
    <description>The quality of life of the participants will be measured by the Hong Kong Chinese Version World Health Organization quality of life measure, abbreviated version (WHOQOL-BREF (HK)). It consists of 28 items with a five-point response Likert scale. There are two questions to access the overall perception of quality of life and health respectively. The remaining 26 items were designed to assess the perception of quality of life in four particular domains including physical health, psychological well-being, social relationships and environments. Higher scores represent higher levels of QoL. Participants will be asked to respond to the Hong Kong Chinese Version World Health Organization quality of life measure, abbreviated version (WHOQOL-BREF (HK)) at baseline.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Levels of self-esteem at baseline</measure>
    <time_frame>baseline</time_frame>
    <description>The self-esteem of the participants will be measured by the Chinese version of the Rosenberg Self-esteem Scale (RSES). RSES consists of 10 items with a four-point response Likert scale ranging from 1 (strongly agree) to 4 (strongly disagree) and the total scores is ranging from 10 to 40. Higher scores represent higher levels of self-esteem. Participants will be asked to respond to the Chinese version of the Rosenberg Self-esteem Scale (RSES) at baseline.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of depressive symptoms at baseline</measure>
    <time_frame>baseline</time_frame>
    <description>The number of depressive symptoms of the participants will be measured by the Center for Epidemiological Studies - Depression Scale (CES-D). It is able to assess the numbers of depressive symptoms due to the experience of past week. The scale consists of 20 items with four-point Likert scale for patients to response and the total score is ranging from 0 to 60. Higher scores represent greater numbers of depressive symptoms while lower scores represent fewer numbers of depressive symptoms. Participants will be asked to respond to the Center for Epidemiological Studies - Depression Scale (CES-D) at baseline.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Level of sense of hope at baseline</measure>
    <time_frame>baseline</time_frame>
    <description>The sense of hope of the participants will be measured by the Chinese version of Herth Hope Index (HHI). It is a 12-item psychometric scale to measure the sense of hope. Each item contains four-point scale (&quot;strong disagree&quot; = &quot;1&quot;, &quot;disagree&quot; = &quot;2&quot;, &quot;agree&quot; = &quot;3&quot;, &quot;strong agree&quot; = &quot;4&quot;). The total score of the 12 items ranging from 12 to 48 and higher scores imply increasing hopefulness. Participants will be asked to respond to the Chinese version of the Herth Hope Index (HHI) at baseline.</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">240</enrollment>
  <condition>Childhood Osteosarcoma</condition>
  <arm_group>
    <arm_group_label>Survivors of Childhood Osteosarcoma</arm_group_label>
    <description>Survivors of Childhood Osteosarcoma were invited to fill in a set of questionnaires.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Healthy Subjects</arm_group_label>
    <description>Healthy Subjects were invited to fill in a set of questionnaires.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Questionnaires</intervention_name>
    <description>Participants were asked to respond to the questionnaires including Hong Kong Chinese Version World Health Organization quality of life measure, abbreviated version (WHOQOL-BREF (HK)), the Chinese version of The Center for Epidemiological Studies - Depression Scale (CES-D), the Chinese version of Rosenberg self-esteem scale, and the Chinese version of the Herth Hope Index (HHI).</description>
    <arm_group_label>Healthy Subjects</arm_group_label>
    <arm_group_label>Survivors of Childhood Osteosarcoma</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Hong Kong Chinese under the age of 30 years who completed the entire course of treatment at&#xD;
        least 5 years and were diagnosed with osteosarcoma under the age of 19 years.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Hong Kong Chinese under the age of 30 years at the time of study participation;&#xD;
&#xD;
          -  Diagnosed with osteosarcoma under the age of 19 years;&#xD;
&#xD;
          -  Completed the entire course of treatment at least 5 years;&#xD;
&#xD;
          -  Able to speak fluent Cantonese and read Chinese.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Survivors with secondary malignancy, organic cause psychosis, cognitive or learning&#xD;
             problems, or under active cancer treatment&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>30 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ho Cheung William Li</last_name>
    <role>Principal Investigator</role>
    <affiliation>The University of Hong Kong</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Ho Cheung William Li</last_name>
    <phone>39176634</phone>
    <email>william3@hku.hk</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Long Kwan Ho</last_name>
    <phone>39176643</phone>
    <email>longkwan@hku.hk</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>The University of Hong Kong</name>
      <address>
        <city>Hong Kong</city>
        <country>Hong Kong</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Ho Cheung William Li, PhD</last_name>
      <phone>39176634</phone>
      <email>william3@hku.hk</email>
    </contact>
    <investigator>
      <last_name>Ho Cheung William Li, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Hong Kong</country>
  </location_countries>
  <verification_date>November 2020</verification_date>
  <study_first_submitted>September 27, 2017</study_first_submitted>
  <study_first_submitted_qc>September 29, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 2, 2017</study_first_posted>
  <last_update_submitted>September 6, 2021</last_update_submitted>
  <last_update_submitted_qc>September 6, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">September 8, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Osteosarcoma</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/NCT03298971
org study id: UW 17-331
nct id: NCT03298971
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The aim of the study is to examine the impact of cancer and treatment-related effects on the
      physical and psychosocial well-being and quality of life among Hong Kong Chinese survivors of
      childhood osteosarcoma.
Osteosarcoma is the most common primary malignant bone tumor in children and adolescents. The
      5-year overall survival rates of childhood osteosarcoma survivors have been increasing
      substantially with a percentage approaching to 70%. Regrettably, the improved survival rates
      may lead to long-term sequelae related to disease and treatments that can negatively affect
      survivors' physical and psychological well-being. Despite numerous studies have examined the
      impact of cancer and treatment-related late effects on the physical and psychological aspects
      of osteosarcoma survivors in the foreign countries, it has not been studied specifically in
      Hong Kong Chinese population. Problems arise when there is a difference in perception and
      recognition of psychological problems and emotional well-being between Western and Chinese
      culture. Moreover, the difference in coping strategies between Chinese and Western children
      also affects how they react and cope with the devastating effect from cancer and its
      treatments. Due to the cultural and belief differences, the findings from those studies in
      the foreign counties may not be applicable and transferable in Hong Kong context. There is
      thus an imperative need to investigate the impact of cancer and treatment-related effects on
      the physical and psychosocial well-being and quality of life among Hong Kong Chinese
      survivors of childhood osteosarcoma in order to raise awareness of the holistic wellness of
      osteosarcoma survivors.
observational model: Cohort
time perspective: Cross-Sectional
measure: Levels of quality of life at baseline
time frame: baseline
description: The quality of life of the participants will be measured by the Hong Kong Chinese Version World Health Organization quality of life measure, abbreviated version (WHOQOL-BREF (HK)). It consists of 28 items with a five-point response Likert scale. There are two questions to access the overall perception of quality of life and health respectively. The remaining 26 items were designed to assess the perception of quality of life in four particular domains including physical health, psychological well-being, social relationships and environments. Higher scores represent higher levels of QoL. Participants will be asked to respond to the Hong Kong Chinese Version World Health Organization quality of life measure, abbreviated version (WHOQOL-BREF (HK)) at baseline.
measure: Levels of self-esteem at baseline
time frame: baseline
description: The self-esteem of the participants will be measured by the Chinese version of the Rosenberg Self-esteem Scale (RSES). RSES consists of 10 items with a four-point response Likert scale ranging from 1 (strongly agree) to 4 (strongly disagree) and the total scores is ranging from 10 to 40. Higher scores represent higher levels of self-esteem. Participants will be asked to respond to the Chinese version of the Rosenberg Self-esteem Scale (RSES) at baseline.
measure: Number of depressive symptoms at baseline
time frame: baseline
description: The number of depressive symptoms of the participants will be measured by the Center for Epidemiological Studies - Depression Scale (CES-D). It is able to assess the numbers of depressive symptoms due to the experience of past week. The scale consists of 20 items with four-point Likert scale for patients to response and the total score is ranging from 0 to 60. Higher scores represent greater numbers of depressive symptoms while lower scores represent fewer numbers of depressive symptoms. Participants will be asked to respond to the Center for Epidemiological Studies - Depression Scale (CES-D) at baseline.
measure: Level of sense of hope at baseline
time frame: baseline
description: The sense of hope of the participants will be measured by the Chinese version of Herth Hope Index (HHI). It is a 12-item psychometric scale to measure the sense of hope. Each item contains four-point scale ("strong disagree" = "1", "disagree" = "2", "agree" = "3", "strong agree" = "4"). The total score of the 12 items ranging from 12 to 48 and higher scores imply increasing hopefulness. Participants will be asked to respond to the Chinese version of the Herth Hope Index (HHI) at baseline.
arm group label: Survivors of Childhood Osteosarcoma
description: Survivors of Childhood Osteosarcoma were invited to fill in a set of questionnaires.
arm group label: Healthy Subjects
description: Healthy Subjects were invited to fill in a set of questionnaires.
intervention type: Other
intervention name: Questionnaires
description: Participants were asked to respond to the questionnaires including Hong Kong Chinese Version World Health Organization quality of life measure, abbreviated version (WHOQOL-BREF (HK)), the Chinese version of The Center for Epidemiological Studies - Depression Scale (CES-D), the Chinese version of Rosenberg self-esteem scale, and the Chinese version of the Herth Hope Index (HHI).
arm group label: Healthy Subjects
arm group label: Survivors of Childhood Osteosarcoma
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: 30 Years
healthy volunteers: No
last name: Ho Cheung William Li
role: Principal Investigator
affiliation: The University of Hong Kong
last name: Ho Cheung William Li
phone: 39176634
email: william3@hku.hk
last name: Long Kwan Ho
phone: 39176643
email: longkwan@hku.hk
facility: 
status: Recruiting
contact: 
investigator: 
country: Hong Kong
responsible party type: Sponsor
mesh term: Osteosarcoma
sharing ipd: No