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/NCT06003335</url>
    </required_header>
    <id_info>
      <org_study_id>uhongkongc9ttii37</org_study_id>
      <nct_id>NCT06003335</nct_id>
    </id_info>
    <brief_title>Increasing Physical Activity Through Personalised Motivational Messaging to Improve Cognitive Function in Lung Cancer Survivors</brief_title>
    <official_title>Increasing Physical Activity Through Personalised Motivational Messaging to Improve Cognitive Function in Lung Cancer Survivors With Cancer-related Cognitive Impairment: a Randomised Controlled Trial</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>
        Objectives: To examine the effectiveness of a personalised motivational messaging&#xD;
        intervention for improving cognitive function in lung cancer survivors.&#xD;
  &#xD;
        Hypothesis to be tested: Lung cancer survivors receiving personalised motivational messaging&#xD;
        will have better cognitive function than usual care.&#xD;
  &#xD;
        Design and subjects: A randomised controlled trial in 196 lung cancer survivors with&#xD;
        cancer-related cognitive impairment.&#xD;
  &#xD;
        Intervention: The intervention group will be equipped with a wearable activity tracker for 3&#xD;
        months and receive personalised motivational messages via instant messaging applications&#xD;
        (e.g., WhatsApp) to promote physical exercise. The intervention will include 1) regular&#xD;
        messages sent at preferred times and frequencies allowing participants to choose suggested&#xD;
        physical activity goals, and 2) support via chat-type messaging such as goal setting,&#xD;
        real-time counselling, and practical advice. The control group will receive a leaflet on&#xD;
        cognitive impairment with reminder text messages for follow-up surveys.&#xD;
  &#xD;
        Main outcome measures: Data will be conducted at baseline (T0), 3 months (T1; immediately&#xD;
        after intervention delivery), and 6 months (T2; long-term follow up). Primary outcome will be&#xD;
        cognitive function measured by HK-MoCA (objective) and Functional Assessment of Cancer&#xD;
        Therapy-Cognitive Function (FACT-Cog) scale (subjective). Secondary outcomes are physical&#xD;
        activity (IPAQ-SF), self-efficacy for exercise (SEE), psychological well-being (PHQ-4), and&#xD;
        quality of life (EORTC QLQ-C30).&#xD;
  &#xD;
        Data analysis: Intention-to-treat, post-trial qualitative (compliance with the intervention),&#xD;
        and cost-effectiveness analyses will be conducted. We will follow the CONSORT-EHEALTH&#xD;
        checklist.&#xD;
  &#xD;
        Expected results: This trial will provide evidence on the effectiveness of the proposed&#xD;
        intervention on improving cognitive function and increasing physical activity among lung&#xD;
        cancer survivors.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">March 1, 2024</start_date>
    <completion_date type="Anticipated">April 30, 2025</completion_date>
    <primary_completion_date type="Anticipated">February 28, 2025</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>Health Services Research</primary_purpose>
      <masking>Double (Investigator, Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Hong Kong Montreal Cognitive Assessment (HK-MoCA)</measure>
      <time_frame>at baseline (T0), 3 months (T1; immediately after intervention delivery), and 6 months (T2; long-term follow up)</time_frame>
      <description>Primary outcome: objective cognitve function</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Functional Assessment of Cancer Therapy-Cognitive Function (FACT-Cog)</measure>
      <time_frame>at baseline (T0), 3 months (T1; immediately after intervention delivery), and 6 months (T2; long-term follow up)</time_frame>
      <description>Primary outcome: subjective cognitve function</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>International Physical Activity Questionnaire-Short Form (IPAQ-SF)</measure>
      <time_frame>at baseline (T0), 3 months (T1; immediately after intervention delivery), and 6 months (T2; long-term follow up)</time_frame>
      <description>Physical activity</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Self-efficacy for exercise (SEE)</measure>
      <time_frame>at baseline (T0), 3 months (T1; immediately after intervention delivery), and 6 months (T2; long-term follow up)</time_frame>
      <description>Self-efficacy for exercise</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Patient Health Questionnaire 4 item (PHQ-4)</measure>
      <time_frame>at baseline (T0), 3 months (T1; immediately after intervention delivery), and 6 months (T2; long-term follow up)</time_frame>
      <description>Psychological well-being</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30)</measure>
      <time_frame>at baseline (T0), 3 months (T1; immediately after intervention delivery), and 6 months (T2; long-term follow up)</time_frame>
      <description>Quality of life</description>
    </secondary_outcome>
    <number_of_arms>3</number_of_arms>
    <enrollment type="Anticipated">120</enrollment>
    <condition>Neoplasms</condition>
    <condition>Lung Cancer</condition>
    <condition>Physical Inactivity</condition>
    <condition>Cognitive Impairment</condition>
    <arm_group>
      <arm_group_label>IG</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>The intervention group will receive personalised motivational messages (according to their physical activity levels and preferences screened during the baseline measurement) using instant messaging applications (e.g., WhatsApp). They will be equipped with a wearable activity tracker for 3 months to monitor their physical activity level. In accordance with the guidelines for mobile instant messageing development, we will develop a message content library and protocol for intervention delivery.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>CG 1</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Control group 1 will receive regular message delivery (as mentioned in the intervention) without personalised motivational messaging for better evaluation of the effect of personalized motivational messaging.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>CG 2</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>Control group 2 (self-management) will only receive a leaflet containing basic information about CRCI distributed during the recruitment process and text message reminders for follow-up surveys. Regular and real-time support (i.e., chat-type) messages will not be made available to the control group.</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Regular message delivery</intervention_name>
      <description>Regular messages will be sent regularly to each participant over the 12-week study period. As personalisation is a core process in enabling behavioural change, the intervention content, frequency, and timing of the messages will be based on the participants' self-care needs and preferences, which will be surveyed at baseline. If no specific preferences are provided, we will plan the message delivery to decrease in frequency over time as this trend has shown the highest effectiveness in existing studies. The format of messages will be mainly texts, but other formats such as pictures and voice messages will also be considered for addition to the content library to suit a wide range of preferences.</description>
      <arm_group_label>CG 1</arm_group_label>
      <arm_group_label>IG</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Chat-type support message delivery</intervention_name>
      <description>Chat-based support will be given to the participants in addition to the regular message delivery. Instant messaging will be used to communicate directly with the participants. We plan to recruit 10 student RAs who have been trained in the delivery of interactive instant messages (IMs) to provide chat-type support to encourage increased physical activity and interaction. Participants will be invited to set physical activity goals and action plans through the chat-type support. Participants will receive a personalised summary of their physical activity weekly and will be encouraged to reflect on this through a real-time chat (around 5 minutes). They will also be encouraged to establish a plan of how they can adjust their physical activity goal going forward. When addressing the participants' queries or any ethical concerns, the student RAs will be instructed to immediately report to the Principal Applicant and supervisors who are experienced and trained research nurses.</description>
      <arm_group_label>IG</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. aged ≥ 18 years;&#xD;
  &#xD;
            2. diagnosed with stage I-III non-metastatic NSCLC cancer;&#xD;
  &#xD;
            3. completed primary treatment with curative intent (surgery, chemotherapy and/or&#xD;
               radiation therapy) 6 months to 5 years prior to the baseline assessment with no&#xD;
               recurrence or occurrence of additional cancers;&#xD;
  &#xD;
            4. identified as having mild cognitive impairment by the HK-MoCA 5-Min Protocol (≤ 7th&#xD;
               age- and education-corrected percentile cut-off score);&#xD;
  &#xD;
            5. not engaged in regular exercise (defined as &lt; 150 min of moderate-intensity exercise&#xD;
               per week).&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. inadequate reading and verbal Cantonese comprehension for the study activities;&#xD;
  &#xD;
            2. diagnosed with dementia;&#xD;
  &#xD;
            3. unable to use mobile phone text messaging applications (e.g., WhatsApp).&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>School of Nursing, The University of Hong Kong</name>
        <address>
          <city>Hong Kong</city>
          <country>Hong Kong</country>
        </address>
      </facility>
      <contact>
        <last_name>Mu-Hsing Ho, PhD</last_name>
        <phone>+852 39102787</phone>
        <email>mhbho@hku.hk</email>
      </contact>
    </location>
    <location_countries>
      <country>Hong Kong</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 15, 2023</study_first_submitted>
    <study_first_submitted_qc>August 15, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 21, 2023</study_first_posted>
    <last_update_submitted>August 15, 2023</last_update_submitted>
    <last_update_submitted_qc>August 15, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 21, 2023</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>Lung Neoplasms</mesh_term>
      <mesh_term>Cognitive Dysfunction</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/NCT06003335
  org study id: uhongkongc9ttii37
  nct id: NCT06003335
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  Objectives: To examine the effectiveness of a personalised motivational messaging
        intervention for improving cognitive function in lung cancer survivors.
  
        Hypothesis to be tested: Lung cancer survivors receiving personalised motivational messaging
        will have better cognitive function than usual care.
  
        Design and subjects: A randomised controlled trial in 196 lung cancer survivors with
        cancer-related cognitive impairment.
  
        Intervention: The intervention group will be equipped with a wearable activity tracker for 3
        months and receive personalised motivational messages via instant messaging applications
        (e.g., WhatsApp) to promote physical exercise. The intervention will include 1) regular
        messages sent at preferred times and frequencies allowing participants to choose suggested
        physical activity goals, and 2) support via chat-type messaging such as goal setting,
        real-time counselling, and practical advice. The control group will receive a leaflet on
        cognitive impairment with reminder text messages for follow-up surveys.
  
        Main outcome measures: Data will be conducted at baseline (T0), 3 months (T1; immediately
        after intervention delivery), and 6 months (T2; long-term follow up). Primary outcome will be
        cognitive function measured by HK-MoCA (objective) and Functional Assessment of Cancer
        Therapy-Cognitive Function (FACT-Cog) scale (subjective). Secondary outcomes are physical
        activity (IPAQ-SF), self-efficacy for exercise (SEE), psychological well-being (PHQ-4), and
        quality of life (EORTC QLQ-C30).
  
        Data analysis: Intention-to-treat, post-trial qualitative (compliance with the intervention),
        and cost-effectiveness analyses will be conducted. We will follow the CONSORT-EHEALTH
        checklist.
  
        Expected results: This trial will provide evidence on the effectiveness of the proposed
        intervention on improving cognitive function and increasing physical activity among lung
        cancer survivors.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Health Services Research
  masking: Double (Investigator, Outcomes Assessor)
  measure: Hong Kong Montreal Cognitive Assessment (HK-MoCA)
  time frame: at baseline (T0), 3 months (T1; immediately after intervention delivery), and 6 months (T2; long-term follow up)
  description: Primary outcome: objective cognitve function
  measure: Functional Assessment of Cancer Therapy-Cognitive Function (FACT-Cog)
  time frame: at baseline (T0), 3 months (T1; immediately after intervention delivery), and 6 months (T2; long-term follow up)
  description: Primary outcome: subjective cognitve function
  measure: International Physical Activity Questionnaire-Short Form (IPAQ-SF)
  time frame: at baseline (T0), 3 months (T1; immediately after intervention delivery), and 6 months (T2; long-term follow up)
  description: Physical activity
  measure: Self-efficacy for exercise (SEE)
  time frame: at baseline (T0), 3 months (T1; immediately after intervention delivery), and 6 months (T2; long-term follow up)
  description: Self-efficacy for exercise
  measure: Patient Health Questionnaire 4 item (PHQ-4)
  time frame: at baseline (T0), 3 months (T1; immediately after intervention delivery), and 6 months (T2; long-term follow up)
  description: Psychological well-being
  measure: European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30)
  time frame: at baseline (T0), 3 months (T1; immediately after intervention delivery), and 6 months (T2; long-term follow up)
  description: Quality of life
  arm group label: IG
  arm group type: Experimental
  description: The intervention group will receive personalised motivational messages (according to their physical activity levels and preferences screened during the baseline measurement) using instant messaging applications (e.g., WhatsApp). They will be equipped with a wearable activity tracker for 3 months to monitor their physical activity level. In accordance with the guidelines for mobile instant messageing development, we will develop a message content library and protocol for intervention delivery.
  arm group label: CG 1
  arm group type: Active Comparator
  description: Control group 1 will receive regular message delivery (as mentioned in the intervention) without personalised motivational messaging for better evaluation of the effect of personalized motivational messaging.
  arm group label: CG 2
  arm group type: No Intervention
  description: Control group 2 (self-management) will only receive a leaflet containing basic information about CRCI distributed during the recruitment process and text message reminders for follow-up surveys. Regular and real-time support (i.e., chat-type) messages will not be made available to the control group.
  intervention type: Behavioral
  intervention name: Regular message delivery
  description: Regular messages will be sent regularly to each participant over the 12-week study period. As personalisation is a core process in enabling behavioural change, the intervention content, frequency, and timing of the messages will be based on the participants' self-care needs and preferences, which will be surveyed at baseline. If no specific preferences are provided, we will plan the message delivery to decrease in frequency over time as this trend has shown the highest effectiveness in existing studies. The format of messages will be mainly texts, but other formats such as pictures and voice messages will also be considered for addition to the content library to suit a wide range of preferences.
  arm group label: CG 1
  arm group label: IG
  intervention type: Behavioral
  intervention name: Chat-type support message delivery
  description: Chat-based support will be given to the participants in addition to the regular message delivery. Instant messaging will be used to communicate directly with the participants. We plan to recruit 10 student RAs who have been trained in the delivery of interactive instant messages (IMs) to provide chat-type support to encourage increased physical activity and interaction. Participants will be invited to set physical activity goals and action plans through the chat-type support. Participants will receive a personalised summary of their physical activity weekly and will be encouraged to reflect on this through a real-time chat (around 5 minutes). They will also be encouraged to establish a plan of how they can adjust their physical activity goal going forward. When addressing the participants' queries or any ethical concerns, the student RAs will be instructed to immediately report to the Principal Applicant and supervisors who are experienced and trained research nurses.
  arm group label: IG
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  facility: 
  contact: 
  country: Hong Kong
  responsible party type: Sponsor
  mesh term: Lung Neoplasms
  mesh term: Cognitive Dysfunction
  sharing ipd: No