xml: <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/NCT06015009</url>
    </required_header>
    <id_info>
      <org_study_id>2022.461</org_study_id>
      <nct_id>NCT06015009</nct_id>
    </id_info>
    <brief_title>Symptom Management App for Children at the Early Stage of Cancer Survivorship and Their Caregivers</brief_title>
    <official_title>Feasibility, Acceptability, and Effect of a Symptom Management mHealth Application With Personalised Support for Children at the Early Stage of Cancer Survivorship and Their Caregivers: Pre-post Pilot Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Chinese University of Hong Kong</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Chinese 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>
        This pilot trial aims to determine the feasibility, usability, acceptability, and preliminary&#xD;
        effect of the symptom management mHealth app. Participants meeting the aforementioned&#xD;
        criteria (section d(i)) will be eligible to participate.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        In Hong Kong, the incidence of paediatric cancer has been increasing in the past few years,&#xD;
        from 180 new cancer cases in 2017 to 196 cases in 2019. The average 5-year survival rate for&#xD;
        paediatric cancer patients is approximately 85% due to recent advances in cancer treatments.&#xD;
        The success of these treatments has resulted in a rapid growth in the population of&#xD;
        paediatric cancer survivors globally. This population now has an average lifespan of 72&#xD;
        years. Despite the improved survival rate, the high toxicity and low specificity of cancer&#xD;
        treatment given at an early age induce a myriad of deleterious late effects that have a&#xD;
        detrimental impact on survivors' physical and psychosocial well-being. Therefore, children&#xD;
        who have completed cancer treatment require ongoing monitoring for cancer progression and&#xD;
        survivorship care as early as possible to manage the symptoms induced by the invasive&#xD;
        treatment. Symptom management in paediatric oncology nursing is becoming increasingly&#xD;
        important due to the complex treatment modalities. The benefits of effective symptom&#xD;
        management, particularly improvements in physical functioning and reduced psychological&#xD;
        distress, are exponential for children being treated for cancer and their caregivers&#xD;
        throughout the cancer trajectory.&#xD;
  &#xD;
        Paediatric oncology patients receive close monitoring of their somatic symptoms during their&#xD;
        hospital stay, but there is a paucity of symptom management for children who have completed&#xD;
        treatment and are at the early stage of survivorship. During the transition from hospital&#xD;
        stay to home care, children and their caregivers may experience significant psychological&#xD;
        distress due to their concerns about the child's health and uncertainties about coping with&#xD;
        the potential symptom burden or cancer recurrence. During the first year after completing&#xD;
        cancer treatment, many side effects related to the cancer or its treatment may persist, and&#xD;
        other late effects may also develop. The unmet needs for symptom monitoring and management&#xD;
        for paediatric cancer survivors, particularly those in the early stage of survivorship,&#xD;
        warrant immediate attention from healthcare professionals. It is imperative for healthcare&#xD;
        professionals to engage in the rigorous planning, development, and implementation of&#xD;
        appropriate interventions to support symptom management for children in the early stage of&#xD;
        cancer survivorship and their caregivers. These interventions should be implemented at&#xD;
        discharge to manage patient-reported symptoms and improve the children's QoL and survival&#xD;
        rate.&#xD;
  &#xD;
        Given the high utilisation of mobile technologies, integrating mobile technologies into&#xD;
        current cancer survivorship care may be a promising and flexible approach for symptom&#xD;
        management for children in the early stage of cancer survivorship and their caregivers.&#xD;
        Digital health interventions have been shown to be effective at improving patient-reported&#xD;
        outcomes in various patient populations, but there is a lack of such an intervention for&#xD;
        paediatric cancer survivors and their caregivers to ameliorate their symptom burden in their&#xD;
        local contexts (e.g., at home). The proposed study aims to develop a symptom management&#xD;
        mHealth app to support children in the early stage of cancer survivorship and their&#xD;
        caregivers and to evaluate its usability, feasibility, acceptability, and efficacy.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">September 4, 2023</start_date>
    <completion_date type="Anticipated">June 30, 2024</completion_date>
    <primary_completion_date type="Anticipated">April 30, 2024</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>N/A</allocation>
      <intervention_model>Single Group Assignment</intervention_model>
      <primary_purpose>Supportive Care</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Feasibility of the intervention</measure>
      <time_frame>Upon completion of the intervention (3 months)</time_frame>
      <description>Feasibility in terms of (1) the recruitment rate</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Feasibility of the intervention</measure>
      <time_frame>Upon completion of the intervention (3 months)</time_frame>
      <description>Feasibility in terms of (2) response rate</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Feasibility of the intervention</measure>
      <time_frame>Upon completion of the intervention (3 months)</time_frame>
      <description>Feasibility in terms of (3) intervention engagement time and adherence</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Feasibility of the intervention</measure>
      <time_frame>Upon completion of the intervention (3 months)</time_frame>
      <description>Feasibility in terms of (4) retention rate of the study</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Acceptability of the intervention</measure>
      <time_frame>Upon completion of the intervention (3 months)</time_frame>
      <description>Acceptability will be measured using a modified version of the Acceptability E-Scale (AES), a valid and reliable six-item 5-point Likert scale evaluating the acceptability of electronic self-report assessment for oncology population.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Acceptability of the intervention</measure>
      <time_frame>Upon completion of the intervention (3 months)</time_frame>
      <description>Individual, semi-structured interviews will also be conducted to determine the acceptability of the intervention from participants' perspectives.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Severity of child's symptoms</measure>
      <time_frame>3 months after starting the intervention</time_frame>
      <description>The Chinese version of the Patient-Reported Outcomes Measurement Information System® (PROMIS-25) Pediatric-25 Profile version 2.0 is a comprehensive measure document child reports of their symptoms and functioning over the previous seven days. It comprises 24 questions and a single item on pain intensity to evaluate six domains, including physical function, anxiety, depressive symptoms, fatigue, peer relationship, and pain interference. Each domain has Each item has a 5-point Likert scale ranging from ''never'' to ''almost always'' in most domains and from ''with no trouble'' to ''not able to do'' for the physical functioning domain. Higher scores indicate more of the measured symptom being experienced, which signifies worse functioning for anxiety, depression, fatigue, and pain interference, and better physical functioning, and peer relationships.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Caregivers' quality of life</measure>
      <time_frame>3 months after starting the intervention</time_frame>
      <description>Primary caregivers' quality of life will be assessed using the Chinese version of the World Health Organization's Quality of Life Instrument at baseline and 3 months after starting the intervention. It is a generic health status measure in assessing the overall QoL and general health (2 items), physical health (7 items), psychological health (6 items), social relationships (3 items), and environment (8 items) using a five-point Likert scale. The item scores were added to calculate the domain scores, where a higher score indicates better quality of life.</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">40</enrollment>
    <condition>Oncology</condition>
    <condition>Survivorship</condition>
    <arm_group>
      <arm_group_label>Intervention group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Child-caregiver dyads in the intervention group will use the mHealth app for 12 weeks with personalised nurse support via interactive communication technologies. The design of the app will be guided by the theory of unpleasant symptoms.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Symptom management mobile health application with personalised support</intervention_name>
      <description>Other: Symptom management mobile health application with personalised support Child-caregiver dyads in the intervention group will use the mHealth app for 12 weeks with personalised nurse support via interactive communication technologies. The design of the app will be guided by the theory of unpleasant symptoms.&#xD;
  The app will comprise several interactive elements to provide children and their caregivers with real-time symptom management support. Comprehensive educational materials regarding cancer and its treatment side effects, including possible symptoms, functional limitations, and psychological responses, will be provided in the app for the children and their caregivers to gain a thorough understanding of the potential symptom burden that they may experience.</description>
      <arm_group_label>Intervention group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
          Chinese paediatric cancer survivors will be included if they&#xD;
  &#xD;
            -  are aged 9 to 16 years,&#xD;
  &#xD;
            -  are able to read Chinese and communicate in Chinese,&#xD;
  &#xD;
            -  have completed active cancer treatment (within the previous 2 years), as early symptom&#xD;
               management support is crucial to reduce the symptom burden in survivors and their&#xD;
               caregivers throughout their survivorship, and&#xD;
  &#xD;
            -  have a smartphone or tablet and are willing to install the mHealth app.&#xD;
  &#xD;
          The primary caregiver of the paediatric cancer survivors (either the mother or father)&#xD;
  &#xD;
            -  are able to read Chinese and communicate in Chinese, and&#xD;
  &#xD;
            -  have a smartphone or tablet and are willing to install the mHealth app with their&#xD;
               children surviving cancer&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
          Chinese paediatric cancer survivors will be excluded if they&#xD;
  &#xD;
            -  have cognitive impairments or psychiatric illnesses&#xD;
  &#xD;
            -  are currently participating in other symptom management studies, or&#xD;
  &#xD;
            -  have evidence of secondary malignancy or recurrence&#xD;
  &#xD;
          The primary caregivers of the paediatric cancer survivors (either the mother or father)&#xD;
          will be excluded if they have cognitive impairments or psychiatric illnesses.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>9 Years</minimum_age>
      <maximum_age>16 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Ankie Tan Cheung, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Chinese University of Hong Kong</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Ankie Tan Cheung, PhD</last_name>
      <phone>852 3943 0515</phone>
      <email>ankiecheung@cuhk.edu.hk</email>
    </overall_contact>
    <location>
      <facility>
        <name>The Chinese University of Hong Kong</name>
        <address>
          <city>Hong Kong</city>
          <country>Hong Kong</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Ankie Tan Cheung, PhD</last_name>
        <phone>852 39430515</phone>
        <email>ankiecheung@cuhk.edu.hk</email>
      </contact>
    </location>
    <location_countries>
      <country>Hong Kong</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 23, 2023</study_first_submitted>
    <study_first_submitted_qc>August 26, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 28, 2023</study_first_posted>
    <last_update_submitted>September 6, 2023</last_update_submitted>
    <last_update_submitted_qc>September 6, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 8, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Chinese University of Hong Kong</investigator_affiliation>
      <investigator_full_name>Cheung Tan</investigator_full_name>
      <investigator_title>Assistant Professor</investigator_title>
    </responsible_party>
    <keyword>symptom management</keyword>
    <keyword>cancer</keyword>
    <keyword>children</keyword>
    <keyword>caregiver</keyword>
    <keyword>mobile health</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Neoplasms</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06015009
  org study id: 2022.461
  nct id: NCT06015009
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  This pilot trial aims to determine the feasibility, usability, acceptability, and preliminary
        effect of the symptom management mHealth app. Participants meeting the aforementioned
        criteria (section d(i)) will be eligible to participate.
  In Hong Kong, the incidence of paediatric cancer has been increasing in the past few years,
        from 180 new cancer cases in 2017 to 196 cases in 2019. The average 5-year survival rate for
        paediatric cancer patients is approximately 85% due to recent advances in cancer treatments.
        The success of these treatments has resulted in a rapid growth in the population of
        paediatric cancer survivors globally. This population now has an average lifespan of 72
        years. Despite the improved survival rate, the high toxicity and low specificity of cancer
        treatment given at an early age induce a myriad of deleterious late effects that have a
        detrimental impact on survivors' physical and psychosocial well-being. Therefore, children
        who have completed cancer treatment require ongoing monitoring for cancer progression and
        survivorship care as early as possible to manage the symptoms induced by the invasive
        treatment. Symptom management in paediatric oncology nursing is becoming increasingly
        important due to the complex treatment modalities. The benefits of effective symptom
        management, particularly improvements in physical functioning and reduced psychological
        distress, are exponential for children being treated for cancer and their caregivers
        throughout the cancer trajectory.
  
        Paediatric oncology patients receive close monitoring of their somatic symptoms during their
        hospital stay, but there is a paucity of symptom management for children who have completed
        treatment and are at the early stage of survivorship. During the transition from hospital
        stay to home care, children and their caregivers may experience significant psychological
        distress due to their concerns about the child's health and uncertainties about coping with
        the potential symptom burden or cancer recurrence. During the first year after completing
        cancer treatment, many side effects related to the cancer or its treatment may persist, and
        other late effects may also develop. The unmet needs for symptom monitoring and management
        for paediatric cancer survivors, particularly those in the early stage of survivorship,
        warrant immediate attention from healthcare professionals. It is imperative for healthcare
        professionals to engage in the rigorous planning, development, and implementation of
        appropriate interventions to support symptom management for children in the early stage of
        cancer survivorship and their caregivers. These interventions should be implemented at
        discharge to manage patient-reported symptoms and improve the children's QoL and survival
        rate.
  
        Given the high utilisation of mobile technologies, integrating mobile technologies into
        current cancer survivorship care may be a promising and flexible approach for symptom
        management for children in the early stage of cancer survivorship and their caregivers.
        Digital health interventions have been shown to be effective at improving patient-reported
        outcomes in various patient populations, but there is a lack of such an intervention for
        paediatric cancer survivors and their caregivers to ameliorate their symptom burden in their
        local contexts (e.g., at home). The proposed study aims to develop a symptom management
        mHealth app to support children in the early stage of cancer survivorship and their
        caregivers and to evaluate its usability, feasibility, acceptability, and efficacy.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Supportive Care
  masking: None (Open Label)
  measure: Feasibility of the intervention
  time frame: Upon completion of the intervention (3 months)
  description: Feasibility in terms of (1) the recruitment rate
  measure: Feasibility of the intervention
  time frame: Upon completion of the intervention (3 months)
  description: Feasibility in terms of (2) response rate
  measure: Feasibility of the intervention
  time frame: Upon completion of the intervention (3 months)
  description: Feasibility in terms of (3) intervention engagement time and adherence
  measure: Feasibility of the intervention
  time frame: Upon completion of the intervention (3 months)
  description: Feasibility in terms of (4) retention rate of the study
  measure: Acceptability of the intervention
  time frame: Upon completion of the intervention (3 months)
  description: Acceptability will be measured using a modified version of the Acceptability E-Scale (AES), a valid and reliable six-item 5-point Likert scale evaluating the acceptability of electronic self-report assessment for oncology population.
  measure: Acceptability of the intervention
  time frame: Upon completion of the intervention (3 months)
  description: Individual, semi-structured interviews will also be conducted to determine the acceptability of the intervention from participants' perspectives.
  measure: Severity of child's symptoms
  time frame: 3 months after starting the intervention
  description: The Chinese version of the Patient-Reported Outcomes Measurement Information System® (PROMIS-25) Pediatric-25 Profile version 2.0 is a comprehensive measure document child reports of their symptoms and functioning over the previous seven days. It comprises 24 questions and a single item on pain intensity to evaluate six domains, including physical function, anxiety, depressive symptoms, fatigue, peer relationship, and pain interference. Each domain has Each item has a 5-point Likert scale ranging from ''never'' to ''almost always'' in most domains and from ''with no trouble'' to ''not able to do'' for the physical functioning domain. Higher scores indicate more of the measured symptom being experienced, which signifies worse functioning for anxiety, depression, fatigue, and pain interference, and better physical functioning, and peer relationships.
  measure: Caregivers' quality of life
  time frame: 3 months after starting the intervention
  description: Primary caregivers' quality of life will be assessed using the Chinese version of the World Health Organization's Quality of Life Instrument at baseline and 3 months after starting the intervention. It is a generic health status measure in assessing the overall QoL and general health (2 items), physical health (7 items), psychological health (6 items), social relationships (3 items), and environment (8 items) using a five-point Likert scale. The item scores were added to calculate the domain scores, where a higher score indicates better quality of life.
  arm group label: Intervention group
  arm group type: Experimental
  description: Child-caregiver dyads in the intervention group will use the mHealth app for 12 weeks with personalised nurse support via interactive communication technologies. The design of the app will be guided by the theory of unpleasant symptoms.
  intervention type: Other
  intervention name: Symptom management mobile health application with personalised support
  description: Other: Symptom management mobile health application with personalised support Child-caregiver dyads in the intervention group will use the mHealth app for 12 weeks with personalised nurse support via interactive communication technologies. The design of the app will be guided by the theory of unpleasant symptoms.
  The app will comprise several interactive elements to provide children and their caregivers with real-time symptom management support. Comprehensive educational materials regarding cancer and its treatment side effects, including possible symptoms, functional limitations, and psychological responses, will be provided in the app for the children and their caregivers to gain a thorough understanding of the potential symptom burden that they may experience.
  arm group label: Intervention group
  criteria: 
  gender: All
  minimum age: 9 Years
  maximum age: 16 Years
  healthy volunteers: No
  last name: Ankie Tan Cheung, PhD
  role: Principal Investigator
  affiliation: Chinese University of Hong Kong
  last name: Ankie Tan Cheung, PhD
  phone: 852 3943 0515
  email: ankiecheung@cuhk.edu.hk
  facility: 
  status: Recruiting
  contact: 
  country: Hong Kong
  responsible party type: Principal Investigator
  investigator affiliation: Chinese University of Hong Kong
  investigator full name: Cheung Tan
  investigator title: Assistant Professor
  mesh term: Neoplasms
  sharing ipd: No