<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/NCT03757637</url>
  </required_header>
  <id_info>
    <org_study_id>201712196RIND</org_study_id>
    <nct_id>NCT03757637</nct_id>
  </id_info>
  <brief_title>Compare the Effects of NLSCP and Interactive ICT Supported HAP on Differentiate Diagnosed Thyroid Cancer Patients</brief_title>
  <official_title>Yeur-Hur Lai, PhD, RN, School of Nursing, College of Medicine, National Taiwan University</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>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Background: Despite the good prognosis of patients with differentiated thyroid carcinomas&#xD;
      (DTC), the diagnosis of cancer, fear of cancer recurrence and its side effects might still&#xD;
      bring impacts on patients' quality of life and daily function.&#xD;
&#xD;
      Purposes: This is a two-phase study. Phase I will aim to examine the current concerns of&#xD;
      patients' physical-, psychological, care needs, and physical and psychological function in&#xD;
      DTC patients within one year of diagnosis, and identify factors related to patients' physical&#xD;
      and psychological functions. Phase II will be a three-group randomized control trail (RCT).&#xD;
      The aims will be develop two intervention programs: Nurse-led Survivorship Care Program&#xD;
      (NLSCP, Exp-1) and Information &amp; Communication Technology (ICT) Supported Healthy Active&#xD;
      Program (ICT supported HAP, Exp-2), and compare the effects of the two intervention groups&#xD;
      and control group of their effects on the variables in the above mentioned four dimensions&#xD;
      (physical, psychological, care needs, function) in newly diagnosed DTC patients receiving&#xD;
      total thyroidectomy.&#xD;
&#xD;
      Methods: Phase I is a cross-sectional survey study and to examine the current status of&#xD;
      physical distress (e.g., fatigue, pain), psychological distress (e.g., depression,&#xD;
      body-image), care needs, and psychological &amp; physical functions. Phase II is a 6-month&#xD;
      three-group RCT with 12 month follow-up of its effects. There will have 5 intervention&#xD;
      sections during the first 6 month. Control group will be case manager care only. The NLSCP&#xD;
      will receive face-to-face or telephone education by trained nurse. The ICT supported HAP&#xD;
      group will receive information or counseling through mobile phone App as the schedule&#xD;
      intervention time. For both Exp groups, the first 2 sections of interventions will be all&#xD;
      delivered face-to-face for helping them to be familiar with the operation system. Patients in&#xD;
      the ICT supported HAP group can raise their concerns or questions through APP and receive&#xD;
      intervention through App interactively. The outcomes will be assessed at 5 time points: time&#xD;
      before first intervention (baseline assessment), 4-5 week before intervention, 3-, 6-, and 12&#xD;
      months.&#xD;
&#xD;
      Expected Outcome: We expect this study can help us better understanding DTC patients' impacts&#xD;
      and care needs. The comparison of three groups of intervention will also help us to identify&#xD;
      the best model to decrease distress and enhance life function for them.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Phase I is a cross-sectional survey study (first year) with the specific aims to examine the&#xD;
      current status of physical distress (fatigue, sleep dysfunction, other symptoms),&#xD;
      psychological distress (fear of cancer recurrence, depression, body-image), care needs, and&#xD;
      psychological &amp; physical functions in DTC patients diagnosed within three years. We will also&#xD;
      examine these factors of their relationship with physical and psychological function by&#xD;
      short-form -12.&#xD;
&#xD;
      Phase II is a 6-month three-group randomized controlled trial with 12 month follow-up of its&#xD;
      effects. Eligible subjects will be those newly diagnosed DTC patients with total&#xD;
      thyroidectomy. A stratified randomization by age (age 45 as cut-off point) and gender would&#xD;
      be conducted. Although the different intervention designs in the two intervention groups&#xD;
      (NLSCP &amp; ICT supported HAP). The three groups, control and two intervention groups (Exp-1 &amp;&#xD;
      Exp-2) will all receive the hospital routine and case manager's care. The three groups will&#xD;
      receive baseline assessment before first intervention during hospitalization. We will first&#xD;
      build up the contents and operable programs for two interventions groups: nurse-led&#xD;
      survivorship care program (NLSCP/ Exp-1) and ICT supported HAP (ICT supported HAP/ Exp-2).&#xD;
      Both intervention groups will also receive routine case manager care too. For both&#xD;
      intervention groups, there will have 5 intervention sections during the first 6 month,&#xD;
      including one day before hospital discharge post-operation, 5-6th week and 2-, 3-, 5- month&#xD;
      post operation, known as intervention 1-5, respectively.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">December 1, 2018</start_date>
  <completion_date type="Anticipated">December 31, 2022</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2022</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>
    <intervention_model_description>There are various models of SCP, in general, the primary care physician model or nurse-led model are generally being recognized for effective detecting patients' distress and recurrences, effective coordination and communication, and taking SCP as standard cancer care. In Taiwan, we take a large number of advanced DTC patients, it is important to integrate the SCP but also need to concern about the limited time in busy OPD clinics and patients' differences because of various physical or psychological conditions and needs. We will build up the contents and operable programs for two interventions groups: NLSCP and ICT supported HAP.</intervention_model_description>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>Triple (Care Provider, Investigator, Outcomes Assessor)</masking>
    <masking_description>This study was not fully blinded; however, the group allocation was concealed from the patient and primary researcher until after baseline assessments were completed. A primary researcher obtained patient consent, collected selfreported assessments, and if the patients were randomized to intervention group, the intervention trainer explained the exercise program to participants. The study statistician and data managers remained blinded at all times.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Hospital Anxiety &amp; Depression Scale (HADS)</measure>
    <time_frame>For all groups, we will assess patients' outcomes (including baseline data) for 5 times (T1=baseline/during hospitalization of receiving surgery &amp; before their hospital; T2 to T6 = 1, 3, 6, and 12 months after discharge from hospital).</time_frame>
    <description>The severity of lung cancer patients' anxiety and depression will be measured by the self-reporting HADS. The 14 items of HADS consists of two subscales, include 7 items anxiety and 7 items depression. The score of all items ranges from 0 (not at all) to 3 (always) and the total score of each subscale arerange from 0 to 21, a higher score indicates a higher level of anxiety or depression. Satisfactory psychometrics of the HADS has been shown in cancer populations in Taiwan (Chen et al. 2000).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Fear of Recurrence Inventory</measure>
    <time_frame>For all groups, we will assess patients' outcomes (including baseline data) for 5 times (T1=baseline/during hospitalization of receiving surgery &amp; before their hospital; T2 to T6 = 1, 3, 6, and 12 months after discharge from hospital).</time_frame>
    <description>The FoR-C is a Chinese version of the original FoR questionnaire. The FoR questionnaire consists of six statements with a five-point response scale from not at all (1), a little, sometimes (2), a lot , and all the time) and one statement with a response scale from 0 (not at all) to 10 (a great deal). The summary of FoR was range from 6 to 40. Higher score indicates a higher level of fear of recurrence. The significance of the FoR was indicated by patients' responses 'a lot' or 'all the time' for the first six statements and the score of 7-10 for the last item, in which case. Current study will use the same approach to determine the cut-off point of the FoR.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Body Image Scale (BIS)</measure>
    <time_frame>For all groups, we will assess patients' outcomes (including baseline data) for 5 times (T1=baseline/during hospitalization of receiving surgery &amp; before their hospital; T2 to T6 = 1, 3, 6, and 12 months after discharge from hospital).</time_frame>
    <description>The Body Image Scale (BIS) was developed to assess body image. The 10-item BIS comprised three subscales: affective (e.g. feeling feminine/masculine, physically attractive, or sexually attractive), behavioral (e.g. find it hard to look at youeself naked, avoid people because of appearance), and cognitive (e.g. satisfied with appearance, or with scar). Five items were presented positively and the others were presented negatively. Each item was scored from 0 (not at all) to 3 (very much). The higher overall summary score indicated more symptoms and distress. (Hopwood, Fletcher, Lee, &amp; Al Ghazal, 2001) The BIS has been translated to Chinese and validated to be reliable in cancer patients in Taiwan. Cronbach's α was 0.84-0.94. (Chen, Liao, Chen, Chan, &amp; Chen, 2012; Chen et al., 2017; Hung et al., 2017).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Fatigue Severity Inventory</measure>
    <time_frame>For all groups, we will assess patients' outcomes (including baseline data) for 5 times (T1=baseline/during hospitalization of receiving surgery &amp; before their hospital; T2 to T6 = 1, 3, 6, and 12 months after discharge from hospital).</time_frame>
    <description>The Fatigue Symptom Inventory (FSI) was developed to assess fatigue in patients with cancer. It's a 14-item self-reported measure designed to assess the intensity (four items), duration (two items), daily pattern (one item) and inference (seven items) of fatigue. The Items assessing intensity and interference are scored on an 11-point Likert-type scale (0 = not at all fatigued/ no inference at all; 10 = as fatigued as I could be/ extreme inference). Two items assessing duration are based on the number of days in the past week patients felt fatigue (0 - 7 days) and the percent of time each day fatigue was present (0 = none of the day; 10 = the entire day). (Hann, Denniston, &amp; Baker, 2000; Hann et al., 1998) The Chinese version of FSI has been validated in patients with cancer and its Cronbach's α was 0.92. (Chou, Lai, Wang, &amp; Shun, 2017; Shun, Beck, Pett, &amp; Berry, 2006; Shun, Beck, Pett, &amp; Richardson, 2007).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pittsburgh's Sleep Index</measure>
    <time_frame>For all groups, we will assess patients' outcomes (including baseline data) for 5 times (T1=baseline/during hospitalization of receiving surgery &amp; before their hospital; T2 to T6 = 1, 3, 6, and 12 months after discharge from hospital).</time_frame>
    <description>The PSQI was developed by Buysee in 1989, is used to assess sleep quality on participants' sleep experiences during the past week (Buysse, Reynolds, Monk, Berman, &amp; Kupfer, 1989). Iincluding seven component scores which are sleep duration, sleep disturbances, sleep latency, daytime functioning, habitual sleep efficiency, sleep quality, and sleep medication. The total PSQI score range is from 0 to 21, and the higher the worse of the sleep. If the total PSQI score is more than 5, the result means the person has sleep problems (Buysse et al., 1989; He et al., 2015; Van Onselen et al., 2010). In Chinese-PSQI, Cronbach's a coefficient for the hospital sample and test-retest reliability were 0.83 and 0.85, respectively (Tsai et al., 2005). Normal and problem sleepers (PSQI total score≦5 or &gt;5) had 90% of sensitivity and 87% of specificity in original questionnaire (Buysse et al., 1989) and had 98% of sensitivity and 55% of specificity in Chinese version questionnaire (Tsai et al., 2005).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Brief Supportive Care Needs Survey (SCNS-9)</measure>
    <time_frame>For all groups, we will assess patients' outcomes (including baseline data) for 5 times (T1=baseline/during hospitalization of receiving surgery &amp; before their hospital; T2 to T6 = 1, 3, 6, and 12 months after discharge from hospital).</time_frame>
    <description>The unmet needs of lung cancer patient will be measured by 9 items SCNS. It consists of 5 domains, include psychological, health system and information, daily living, patient care and sexuality domain. Response options &quot;No need, not applicable (1); No need, satisfied (2); Low need (3); Moderate need (4); High need (5). The sum of item scores within each domain will be calculated and the scores will be transformed to a standardized score 0 to 100, higher score indicate more unmet needs (Girgis, Stojanovski, Boyes, King, &amp; Lecathelinais, 2011). The higher scores representing more unmet needs (McElduff, Boyes, Zucca, &amp; Girgis, 2004). A previous study reported the construct reliability and construct validity of this instrument (Girgis et al, 2011). The Chinese SCNS34 has acceptable psychometric properties in previous lung cancer studies (Liao et al., 2011; Shun et al., 2014).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Short Form 12 (SF-12)</measure>
    <time_frame>For all groups, we will assess patients' outcomes (including baseline data) for 5 times (T1=baseline/during hospitalization of receiving surgery &amp; before their hospital; T2 to T6 = 1, 3, 6, and 12 months after discharge from hospital).</time_frame>
    <description>The Short Form-12 (SF-12) Health Survey is a shortened version of the 36-item Short Form Health Survey with 12 items. It's a generic and validated self-reported health-related quality-of-life questionnaire. The SF-12 consists of eight-scale scores and two summary measures: physical and mental component summary measures (PCS and MCS). It includes two items on physical functioning, two items on role physical, one item on bodily pain, one item on general health, one item on vitality, one item on social functioning, two items on role emotional, and two items on mental health. (Busija et al., 2011; Fong et al., 2010; Ware et al., 1996) The SF-12 scores are calculated by summing the raw scores and transform to a 0-100 scale. The higher score indicated better health. (Busija et al., 2011) The previous study reported Cronbach's α for the Chinese version of the PCS was 0.62-0.83 and the MCS was 0.75-0.76. (Chou, Lai, Wang, &amp; Shun, 2017; Fong et al., 2010).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Symptom Severity Scale (SSS)</measure>
    <time_frame>For all groups, we will assess patients' outcomes (including baseline data) for 5 times (T1=baseline/during hospitalization of receiving surgery &amp; before their hospital; T2 to T6 = 1, 3, 6, and 12 months after discharge from hospital).</time_frame>
    <description>Symptom Severity Scale was developed to assess patients' symptom severity, and it will be modified to assess disease and treatment-related symptoms in DTC patients. Each item of this 23-item SSS is rated from 0 to 10, with 0 indicating &quot;no such symptom at all&quot; and 10 indicating &quot;extreme severity of the symptom.&quot; The SSS has been validated as a reliable scale (Chen et al., 2010; Chen et al., 2013).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Impact of Event Scale-Revised (IES-R)</measure>
    <time_frame>For all groups, we will assess patients' outcomes (including baseline data) for 5 times (T1=baseline/during hospitalization of receiving surgery &amp; before their hospital; T2 to T6 = 1, 3, 6, and 12 months after discharge from hospital).</time_frame>
    <description>The IES is developed by Horowitz et al. (1979) and it was further revised. The IES-R can directly assess the impact of cancer to patients and it is based on mechanisms of people's dealing with calamitous life events. This instrument includes two psychological dimensions: intrusion and avoidance, and it has good psychometrics characteristics. The IES is scored on a 0-5 scale with the higher the score, the more the intrusion and the greater the avoidant tendency or avoidance (Sundin &amp; Horowitz, 2003).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Illness Perception Questionnaire (IPQ-M)</measure>
    <time_frame>For all groups, we will assess patients' outcomes (including baseline data) for 5 times (T1=baseline/during hospitalization of receiving surgery &amp; before their hospital; T2 to T6 = 1, 3, 6, and 12 months after discharge from hospital).</time_frame>
    <description>The Illness Perception Questionnaire (IPQ) was developed by Broadbent, Petrie, Main and Weinman (2006) and it is for measuring patients' perception about their illness. Also the IPQ has been proven a good psychometric measurement. The IPQ was later modified by Grunfeld, and Cooper (2010) to assess cancer patients' concerns, perception and barriers of their return to work. The 26-item IPQ-M which consists of two major dimensions: (1) the impacts of cancer and its treatment on work, and (2) illness perceptions in relation to work was an 8-point Likert's scale scoring from 0 to 7 with the higher score indicating more concerns or barriers about RTW.</description>
  </primary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">380</enrollment>
  <condition>Differentiated Thyroid Cancer</condition>
  <arm_group>
    <arm_group_label>General module</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Control group will be &quot;case manager care only&quot; group. Eligible patients will also invite and receive their first time assessment as baseline during hospitalization. The usual cancer care group will receive routine cancer care in the inpatient wards through OPD visits.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>NLSCP</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>NLSCP group will receive 5 section of NLSCP. Contents of scheduled intervention will be developed baed on the literature mentioned above. Ex 1 group, patients will receive at least 3 times face-to-face NLSCP, and two times by telephone calls for following up.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>ICT supported HAP</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The ICT supported HAP group will receive information or counseling through mobile phone App as the schedule intervention time. For this group, patients will receive two face to face interventions in the first two sections (pre-discharge from hospital and 5th week post-op). It will be delivered by research nurse to intervene patients and help them to build up the App system. Research nurse will also help patients to be familiar with the operation system. The rest parts of the intervention will all through Apps in the scheduled time. Patients can raise their questions and concerns through APPs. Patients in the HAP can raise their concerns or questions through APP and receive interventions or answers through App interactively.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>NLSCP</intervention_name>
    <description>Phase II is a 6-month three-group randomized controlled trial with 12 month follow-up of its effects. In addition to receive hospital routine case manager care, patients in this groups will further receive either NLSCP (Exp-1). Patients will be provided the same major education and counseling contents for the first two section of interventions through face-by-face by trained research nurses at time of (1) first intervention: one day before hospital discharge in post-operation, and (2) second intervention: first OPD visit (first week after hospital discharge). This group will receive a face-to-face education or counseling by trained research nurse.</description>
    <arm_group_label>NLSCP</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>ICT supported HAP</intervention_name>
    <description>Phase II is a 6-month three-group randomized controlled trial with 12 month follow-up of its effects. In addition to receive hospital routine case manager care, patients in the groups will further receive ICT supported HAP (Exp-2) intervention. For this groups, patients will be provided the same major education and counseling contents for the first two section of interventions through face-by-face by trained research nurses at time of (1) first intervention: one day before hospital discharge in post-operation, and (2) second intervention: first OPD visit (first week after hospital discharge). The group will receive the interactive mobile phone App.</description>
    <arm_group_label>ICT supported HAP</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  newly diagnosed DTC patients&#xD;
&#xD;
          -  after received thyroid tumor excision operation (total thyroidectomy)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  primary unknown&#xD;
&#xD;
          -  conscious unclear&#xD;
&#xD;
          -  recurrence or with bone meta&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Yeur-Hur Lai, Professor</last_name>
    <role>Study Chair</role>
    <affiliation>School of Nursing, College of Medicine, National Taiwan University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Yeur-Hur Lai</last_name>
    <phone>886-2-23123456</phone>
    <phone_ext>88429</phone_ext>
    <email>laiyhwk@ntu.edu.tw</email>
  </overall_contact>
  <location>
    <facility>
      <name>Department of Surgery, National Taiwan University Hospital, No.7, Chung-Shan South Road, Taipei, TAIWAN, R.O.C.</name>
      <address>
        <city>Taipei</city>
        <zip>100</zip>
        <country>Taiwan</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Yeur-Hur Lai</last_name>
      <email>laiyhwk@ntu.edu.tw</email>
    </contact>
    <investigator>
      <last_name>Yeur-Hur Lai</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
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  <verification_date>November 2022</verification_date>
  <study_first_submitted>November 27, 2018</study_first_submitted>
  <study_first_submitted_qc>November 27, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 29, 2018</study_first_posted>
  <last_update_submitted>November 6, 2022</last_update_submitted>
  <last_update_submitted_qc>November 6, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">November 8, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Thyroid cancer</keyword>
  <keyword>Survivorship Care</keyword>
  <keyword>Mobile applications</keyword>
  <keyword>Mobile phone</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Thyroid Neoplasms</mesh_term>
    <mesh_term>Thyroid Diseases</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/NCT03757637
org study id: 201712196RIND
nct id: NCT03757637
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Background: Despite the good prognosis of patients with differentiated thyroid carcinomas
      (DTC), the diagnosis of cancer, fear of cancer recurrence and its side effects might still
      bring impacts on patients' quality of life and daily function.

      Purposes: This is a two-phase study. Phase I will aim to examine the current concerns of
      patients' physical-, psychological, care needs, and physical and psychological function in
      DTC patients within one year of diagnosis, and identify factors related to patients' physical
      and psychological functions. Phase II will be a three-group randomized control trail (RCT).
      The aims will be develop two intervention programs: Nurse-led Survivorship Care Program
      (NLSCP, Exp-1) and Information & Communication Technology (ICT) Supported Healthy Active
      Program (ICT supported HAP, Exp-2), and compare the effects of the two intervention groups
      and control group of their effects on the variables in the above mentioned four dimensions
      (physical, psychological, care needs, function) in newly diagnosed DTC patients receiving
      total thyroidectomy.

      Methods: Phase I is a cross-sectional survey study and to examine the current status of
      physical distress (e.g., fatigue, pain), psychological distress (e.g., depression,
      body-image), care needs, and psychological & physical functions. Phase II is a 6-month
      three-group RCT with 12 month follow-up of its effects. There will have 5 intervention
      sections during the first 6 month. Control group will be case manager care only. The NLSCP
      will receive face-to-face or telephone education by trained nurse. The ICT supported HAP
      group will receive information or counseling through mobile phone App as the schedule
      intervention time. For both Exp groups, the first 2 sections of interventions will be all
      delivered face-to-face for helping them to be familiar with the operation system. Patients in
      the ICT supported HAP group can raise their concerns or questions through APP and receive
      intervention through App interactively. The outcomes will be assessed at 5 time points: time
      before first intervention (baseline assessment), 4-5 week before intervention, 3-, 6-, and 12
      months.

      Expected Outcome: We expect this study can help us better understanding DTC patients' impacts
      and care needs. The comparison of three groups of intervention will also help us to identify
      the best model to decrease distress and enhance life function for them.
Phase I is a cross-sectional survey study (first year) with the specific aims to examine the
      current status of physical distress (fatigue, sleep dysfunction, other symptoms),
      psychological distress (fear of cancer recurrence, depression, body-image), care needs, and
      psychological & physical functions in DTC patients diagnosed within three years. We will also
      examine these factors of their relationship with physical and psychological function by
      short-form -12.

      Phase II is a 6-month three-group randomized controlled trial with 12 month follow-up of its
      effects. Eligible subjects will be those newly diagnosed DTC patients with total
      thyroidectomy. A stratified randomization by age (age 45 as cut-off point) and gender would
      be conducted. Although the different intervention designs in the two intervention groups
      (NLSCP & ICT supported HAP). The three groups, control and two intervention groups (Exp-1 &
      Exp-2) will all receive the hospital routine and case manager's care. The three groups will
      receive baseline assessment before first intervention during hospitalization. We will first
      build up the contents and operable programs for two interventions groups: nurse-led
      survivorship care program (NLSCP/ Exp-1) and ICT supported HAP (ICT supported HAP/ Exp-2).
      Both intervention groups will also receive routine case manager care too. For both
      intervention groups, there will have 5 intervention sections during the first 6 month,
      including one day before hospital discharge post-operation, 5-6th week and 2-, 3-, 5- month
      post operation, known as intervention 1-5, respectively.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: There are various models of SCP, in general, the primary care physician model or nurse-led model are generally being recognized for effective detecting patients' distress and recurrences, effective coordination and communication, and taking SCP as standard cancer care. In Taiwan, we take a large number of advanced DTC patients, it is important to integrate the SCP but also need to concern about the limited time in busy OPD clinics and patients' differences because of various physical or psychological conditions and needs. We will build up the contents and operable programs for two interventions groups: NLSCP and ICT supported HAP.
primary purpose: Supportive Care
masking: Triple (Care Provider, Investigator, Outcomes Assessor)
masking description: This study was not fully blinded; however, the group allocation was concealed from the patient and primary researcher until after baseline assessments were completed. A primary researcher obtained patient consent, collected selfreported assessments, and if the patients were randomized to intervention group, the intervention trainer explained the exercise program to participants. The study statistician and data managers remained blinded at all times.
measure: Hospital Anxiety & Depression Scale (HADS)
time frame: For all groups, we will assess patients' outcomes (including baseline data) for 5 times (T1=baseline/during hospitalization of receiving surgery & before their hospital; T2 to T6 = 1, 3, 6, and 12 months after discharge from hospital).
description: The severity of lung cancer patients' anxiety and depression will be measured by the self-reporting HADS. The 14 items of HADS consists of two subscales, include 7 items anxiety and 7 items depression. The score of all items ranges from 0 (not at all) to 3 (always) and the total score of each subscale arerange from 0 to 21, a higher score indicates a higher level of anxiety or depression. Satisfactory psychometrics of the HADS has been shown in cancer populations in Taiwan (Chen et al. 2000).
measure: Fear of Recurrence Inventory
time frame: For all groups, we will assess patients' outcomes (including baseline data) for 5 times (T1=baseline/during hospitalization of receiving surgery & before their hospital; T2 to T6 = 1, 3, 6, and 12 months after discharge from hospital).
description: The FoR-C is a Chinese version of the original FoR questionnaire. The FoR questionnaire consists of six statements with a five-point response scale from not at all (1), a little, sometimes (2), a lot , and all the time) and one statement with a response scale from 0 (not at all) to 10 (a great deal). The summary of FoR was range from 6 to 40. Higher score indicates a higher level of fear of recurrence. The significance of the FoR was indicated by patients' responses 'a lot' or 'all the time' for the first six statements and the score of 7-10 for the last item, in which case. Current study will use the same approach to determine the cut-off point of the FoR.
measure: Body Image Scale (BIS)
time frame: For all groups, we will assess patients' outcomes (including baseline data) for 5 times (T1=baseline/during hospitalization of receiving surgery & before their hospital; T2 to T6 = 1, 3, 6, and 12 months after discharge from hospital).
description: The Body Image Scale (BIS) was developed to assess body image. The 10-item BIS comprised three subscales: affective (e.g. feeling feminine/masculine, physically attractive, or sexually attractive), behavioral (e.g. find it hard to look at youeself naked, avoid people because of appearance), and cognitive (e.g. satisfied with appearance, or with scar). Five items were presented positively and the others were presented negatively. Each item was scored from 0 (not at all) to 3 (very much). The higher overall summary score indicated more symptoms and distress. (Hopwood, Fletcher, Lee, & Al Ghazal, 2001) The BIS has been translated to Chinese and validated to be reliable in cancer patients in Taiwan. Cronbach's α was 0.84-0.94. (Chen, Liao, Chen, Chan, & Chen, 2012; Chen et al., 2017; Hung et al., 2017).
measure: Fatigue Severity Inventory
time frame: For all groups, we will assess patients' outcomes (including baseline data) for 5 times (T1=baseline/during hospitalization of receiving surgery & before their hospital; T2 to T6 = 1, 3, 6, and 12 months after discharge from hospital).
description: The Fatigue Symptom Inventory (FSI) was developed to assess fatigue in patients with cancer. It's a 14-item self-reported measure designed to assess the intensity (four items), duration (two items), daily pattern (one item) and inference (seven items) of fatigue. The Items assessing intensity and interference are scored on an 11-point Likert-type scale (0 = not at all fatigued/ no inference at all; 10 = as fatigued as I could be/ extreme inference). Two items assessing duration are based on the number of days in the past week patients felt fatigue (0 - 7 days) and the percent of time each day fatigue was present (0 = none of the day; 10 = the entire day). (Hann, Denniston, & Baker, 2000; Hann et al., 1998) The Chinese version of FSI has been validated in patients with cancer and its Cronbach's α was 0.92. (Chou, Lai, Wang, & Shun, 2017; Shun, Beck, Pett, & Berry, 2006; Shun, Beck, Pett, & Richardson, 2007).
measure: Pittsburgh's Sleep Index
time frame: For all groups, we will assess patients' outcomes (including baseline data) for 5 times (T1=baseline/during hospitalization of receiving surgery & before their hospital; T2 to T6 = 1, 3, 6, and 12 months after discharge from hospital).
description: The PSQI was developed by Buysee in 1989, is used to assess sleep quality on participants' sleep experiences during the past week (Buysse, Reynolds, Monk, Berman, & Kupfer, 1989). Iincluding seven component scores which are sleep duration, sleep disturbances, sleep latency, daytime functioning, habitual sleep efficiency, sleep quality, and sleep medication. The total PSQI score range is from 0 to 21, and the higher the worse of the sleep. If the total PSQI score is more than 5, the result means the person has sleep problems (Buysse et al., 1989; He et al., 2015; Van Onselen et al., 2010). In Chinese-PSQI, Cronbach's a coefficient for the hospital sample and test-retest reliability were 0.83 and 0.85, respectively (Tsai et al., 2005). Normal and problem sleepers (PSQI total score≦5 or >5) had 90% of sensitivity and 87% of specificity in original questionnaire (Buysse et al., 1989) and had 98% of sensitivity and 55% of specificity in Chinese version questionnaire (Tsai et al., 2005).
measure: Brief Supportive Care Needs Survey (SCNS-9)
time frame: For all groups, we will assess patients' outcomes (including baseline data) for 5 times (T1=baseline/during hospitalization of receiving surgery & before their hospital; T2 to T6 = 1, 3, 6, and 12 months after discharge from hospital).
description: The unmet needs of lung cancer patient will be measured by 9 items SCNS. It consists of 5 domains, include psychological, health system and information, daily living, patient care and sexuality domain. Response options "No need, not applicable (1); No need, satisfied (2); Low need (3); Moderate need (4); High need (5). The sum of item scores within each domain will be calculated and the scores will be transformed to a standardized score 0 to 100, higher score indicate more unmet needs (Girgis, Stojanovski, Boyes, King, & Lecathelinais, 2011). The higher scores representing more unmet needs (McElduff, Boyes, Zucca, & Girgis, 2004). A previous study reported the construct reliability and construct validity of this instrument (Girgis et al, 2011). The Chinese SCNS34 has acceptable psychometric properties in previous lung cancer studies (Liao et al., 2011; Shun et al., 2014).
measure: Short Form 12 (SF-12)
time frame: For all groups, we will assess patients' outcomes (including baseline data) for 5 times (T1=baseline/during hospitalization of receiving surgery & before their hospital; T2 to T6 = 1, 3, 6, and 12 months after discharge from hospital).
description: The Short Form-12 (SF-12) Health Survey is a shortened version of the 36-item Short Form Health Survey with 12 items. It's a generic and validated self-reported health-related quality-of-life questionnaire. The SF-12 consists of eight-scale scores and two summary measures: physical and mental component summary measures (PCS and MCS). It includes two items on physical functioning, two items on role physical, one item on bodily pain, one item on general health, one item on vitality, one item on social functioning, two items on role emotional, and two items on mental health. (Busija et al., 2011; Fong et al., 2010; Ware et al., 1996) The SF-12 scores are calculated by summing the raw scores and transform to a 0-100 scale. The higher score indicated better health. (Busija et al., 2011) The previous study reported Cronbach's α for the Chinese version of the PCS was 0.62-0.83 and the MCS was 0.75-0.76. (Chou, Lai, Wang, & Shun, 2017; Fong et al., 2010).
measure: Symptom Severity Scale (SSS)
time frame: For all groups, we will assess patients' outcomes (including baseline data) for 5 times (T1=baseline/during hospitalization of receiving surgery & before their hospital; T2 to T6 = 1, 3, 6, and 12 months after discharge from hospital).
description: Symptom Severity Scale was developed to assess patients' symptom severity, and it will be modified to assess disease and treatment-related symptoms in DTC patients. Each item of this 23-item SSS is rated from 0 to 10, with 0 indicating "no such symptom at all" and 10 indicating "extreme severity of the symptom." The SSS has been validated as a reliable scale (Chen et al., 2010; Chen et al., 2013).
measure: Impact of Event Scale-Revised (IES-R)
time frame: For all groups, we will assess patients' outcomes (including baseline data) for 5 times (T1=baseline/during hospitalization of receiving surgery & before their hospital; T2 to T6 = 1, 3, 6, and 12 months after discharge from hospital).
description: The IES is developed by Horowitz et al. (1979) and it was further revised. The IES-R can directly assess the impact of cancer to patients and it is based on mechanisms of people's dealing with calamitous life events. This instrument includes two psychological dimensions: intrusion and avoidance, and it has good psychometrics characteristics. The IES is scored on a 0-5 scale with the higher the score, the more the intrusion and the greater the avoidant tendency or avoidance (Sundin & Horowitz, 2003).
measure: Illness Perception Questionnaire (IPQ-M)
time frame: For all groups, we will assess patients' outcomes (including baseline data) for 5 times (T1=baseline/during hospitalization of receiving surgery & before their hospital; T2 to T6 = 1, 3, 6, and 12 months after discharge from hospital).
description: The Illness Perception Questionnaire (IPQ) was developed by Broadbent, Petrie, Main and Weinman (2006) and it is for measuring patients' perception about their illness. Also the IPQ has been proven a good psychometric measurement. The IPQ was later modified by Grunfeld, and Cooper (2010) to assess cancer patients' concerns, perception and barriers of their return to work. The 26-item IPQ-M which consists of two major dimensions: (1) the impacts of cancer and its treatment on work, and (2) illness perceptions in relation to work was an 8-point Likert's scale scoring from 0 to 7 with the higher score indicating more concerns or barriers about RTW.
arm group label: General module
arm group type: No Intervention
description: Control group will be "case manager care only" group. Eligible patients will also invite and receive their first time assessment as baseline during hospitalization. The usual cancer care group will receive routine cancer care in the inpatient wards through OPD visits.
arm group label: NLSCP
arm group type: Experimental
description: NLSCP group will receive 5 section of NLSCP. Contents of scheduled intervention will be developed baed on the literature mentioned above. Ex 1 group, patients will receive at least 3 times face-to-face NLSCP, and two times by telephone calls for following up.
arm group label: ICT supported HAP
arm group type: Experimental
description: The ICT supported HAP group will receive information or counseling through mobile phone App as the schedule intervention time. For this group, patients will receive two face to face interventions in the first two sections (pre-discharge from hospital and 5th week post-op). It will be delivered by research nurse to intervene patients and help them to build up the App system. Research nurse will also help patients to be familiar with the operation system. The rest parts of the intervention will all through Apps in the scheduled time. Patients can raise their questions and concerns through APPs. Patients in the HAP can raise their concerns or questions through APP and receive interventions or answers through App interactively.
intervention type: Other
intervention name: NLSCP
description: Phase II is a 6-month three-group randomized controlled trial with 12 month follow-up of its effects. In addition to receive hospital routine case manager care, patients in this groups will further receive either NLSCP (Exp-1). Patients will be provided the same major education and counseling contents for the first two section of interventions through face-by-face by trained research nurses at time of (1) first intervention: one day before hospital discharge in post-operation, and (2) second intervention: first OPD visit (first week after hospital discharge). This group will receive a face-to-face education or counseling by trained research nurse.
arm group label: NLSCP
intervention type: Other
intervention name: ICT supported HAP
description: Phase II is a 6-month three-group randomized controlled trial with 12 month follow-up of its effects. In addition to receive hospital routine case manager care, patients in the groups will further receive ICT supported HAP (Exp-2) intervention. For this groups, patients will be provided the same major education and counseling contents for the first two section of interventions through face-by-face by trained research nurses at time of (1) first intervention: one day before hospital discharge in post-operation, and (2) second intervention: first OPD visit (first week after hospital discharge). The group will receive the interactive mobile phone App.
arm group label: ICT supported HAP
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Yeur-Hur Lai, Professor
role: Study Chair
affiliation: School of Nursing, College of Medicine, National Taiwan University
last name: Yeur-Hur Lai
phone: 886-2-23123456
phone ext: 88429
email: laiyhwk@ntu.edu.tw
facility: 
status: Recruiting
contact: 
investigator: 
country: Taiwan
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responsible party type: Sponsor
mesh term: Thyroid Neoplasms
mesh term: Thyroid Diseases
sharing ipd: No