<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/NCT03794375</url>
  </required_header>
  <id_info>
    <org_study_id>95392418300005327</org_study_id>
    <nct_id>NCT03794375</nct_id>
  </id_info>
  <brief_title>Primary Care Transfer for Thyroid Cancer Patients</brief_title>
  <official_title>Impact of Primary Care Transfer for Thyroid Cancer Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hospital de Clinicas de Porto Alegre</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hospital de Clinicas de Porto Alegre</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>
      Introduction: Differentiated thyroid cancer (DTC) is the most common endocrine malignancy. It&#xD;
      presents low recurrence rates (2-5%) and the consensus of DTC recommends long-term follow-up,&#xD;
      without a definition of maximum follow-up time. The use of Telehealth is a strategy that aims&#xD;
      to optimize the transition of care for patients from tertiary care to primary health care,&#xD;
      helping to follow up these patients.&#xD;
&#xD;
      Objective: To evaluate the impact of the care transition between specialized care and primary&#xD;
      health care of patients with DTC using telemedicine solutions.&#xD;
&#xD;
      Design / Patients: Randomized clinical trial. Patients with DTC with excellent response&#xD;
      (without evidence of disease) after initial treatment.&#xD;
&#xD;
      Interventions / Outcomes: Patients will be randomized to follow-up in face-to-face&#xD;
      consultations in tertiary care or transfer of care to primary care with support from the&#xD;
      Telehealth Center of Rio Grande do Sul. After 18 months, all patients will be evaluated, the&#xD;
      primary outcome being DTC recurrence rate. Outcomes related to quality of life and use of the&#xD;
      health system will also be evaluated. Both follow-up strategies are expected to be&#xD;
      equivalent, making it possible to optimize the use of the health system.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Differentiated thyroid cancer (DTC) is the most frequent malignant neoplasm of the endocrine&#xD;
      system, accounting for approximately 95% of the cases of carcinomas in this system. DTC is&#xD;
      considered to be an indolent behavioral neoplasm with low rates of morbidity and mortality&#xD;
      (mean survival in 10 years from 93 to 98%), being one of the malignancies with a greater&#xD;
      chance of cure.&#xD;
&#xD;
      In recent years, the use of the initial treatment response, called &quot;dynamic risk&#xD;
      classification&quot;, has been advocated in order to better estimate the risk of unfavorable&#xD;
      outcomes in patients with DTC. Using this classification, the recurrence rate in the&#xD;
      contemporary CDT cohorts has been shown to be very low, at a household of 1-5%. In a cohort&#xD;
      of our center, which evaluated 786 patients, the recurrence rate in the group of 357 patients&#xD;
      classified as excellent response after the initial treatment was 2.8%, and none of these&#xD;
      patients presented structural relapse (median follow-up of 4 years). Thus, it is possible to&#xD;
      affirm that most of the patients classified as having an excellent response after initial&#xD;
      treatment are permanently free of disease. However, the main consensus on the management of&#xD;
      DTC recommends long-term follow-up, not defining the maximum follow-up time. This follow-up&#xD;
      consists of consultations in specialized centers (preferably with endocrinologists),&#xD;
      laboratory tests (TSH, thyroglobulin and antithyroglobulin antibody) and imaging.&#xD;
&#xD;
      In Brazil, the health network is characterized by the heterogeneity of hospital structures&#xD;
      regarding the incorporation of technologies and service complexity, with a concentration of&#xD;
      financial resources and specialized personnel in large cities and regional imbalance. Within&#xD;
      this context, specialized outpatients with high complexity face overcrowding (of patients&#xD;
      already under follow-up) and restricted access (to patients in need of follow-up). In this&#xD;
      sense, transferring the care of follow-up patients in specialized hospitals to primary care&#xD;
      level in their place of origin to maintain follow-up brings benefits to individuals and the&#xD;
      system as a whole. The structure of referral of patients to the different levels of care in&#xD;
      the Brazilian public health system occurs through the reference and counter-referral system,&#xD;
      a fundamental point to guarantee the accessibility, universality, and integrality of care. It&#xD;
      is understood as a counter-referral to a primary care level, with a lower degree of&#xD;
      complexity, and should be the health unit closest to the patient's home. Facilitating&#xD;
      mechanisms of reference and counter-reference processes are fundamental to guarantee the&#xD;
      principle of integrality, adequate patient care and rational use of resources.&#xD;
&#xD;
      One of the formats for developing health care support and continuing education activities are&#xD;
      teleconsulting, which are consultations recorded and performed among workers, health&#xD;
      professionals and managers, through telecommunication instruments, with the purpose of&#xD;
      clarifying doubts about clinical procedures, health actions and issues related to the work&#xD;
      process. It is known that this type of systematic intervention based on practice is one of&#xD;
      the most effective ways to promote permanent health education. The use of telehealth, through&#xD;
      teleconsulting, for cases referred by primary care physicians to tertiary services is a&#xD;
      strategy that aims to qualify and reduce referral lists for other medical professionals.&#xD;
      Likewise, the use of telehealth emerges as a counter-referral strategy for patients already&#xD;
      served by tertiary care for primary care units, ensuring patient and physician security of&#xD;
      adequate management and assisted return for tertiary care, when necessary.&#xD;
&#xD;
      In this study, 472 patients with a diagnosis of DTC consecutively attended at the thyroid&#xD;
      clinic of the Hospital de Clínicas of Porto Alegre and who presented excellent response to&#xD;
      the initial treatment will be invited to participate in the study, and then randomized to two&#xD;
      follow-up strategies:&#xD;
&#xD;
        1. Control group: patients will remain in care at the HCPA thyroid disease outpatient&#xD;
           clinic;&#xD;
&#xD;
        2. Intervention group: outpatient discharge with telehealth support.&#xD;
&#xD;
      Patients with definitive postoperative hypoparathyroidism and/or postoperative vocal cord&#xD;
      paralysis requiring tracheostomy will be excluded. All patients will be evaluated by the&#xD;
      study team after completing 18 of follow-up. Clinical, laboratory (TSH, thyroglobulin and&#xD;
      antithyroglobulin antibody) and imaging (cervical ultrasonography) for DTC relapse will be&#xD;
      evaluated in this follow-up visit. The primary endpoint will be the DTC recurrence rate. This&#xD;
      will be divided into biochemistry (when there are only signs of disease in laboratory tests)&#xD;
      and structural (when demonstrated by clinical or imaging examination). Outcomes related to&#xD;
      quality of life and use of the health system will also be evaluated. Both follow-up&#xD;
      strategies are expected to be equivalent in relation to DTC recurrences, potentially enabling&#xD;
      optimization of the use of the health system.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Enrolling by invitation</overall_status>
  <start_date type="Actual">January 1, 2019</start_date>
  <completion_date type="Anticipated">December 31, 2026</completion_date>
  <primary_completion_date type="Anticipated">December 31, 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>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Recurrence rate</measure>
    <time_frame>18 months</time_frame>
    <description>All patients will be evaluated by the study team after completing 18 months of follow-up for this outcome. The presence of recurrence may be identified as a structural disease (evaluated by clinical examination and cervical ultrasound) or biochemical (evaluated by laboratory tests -thyroglobulin and antithyroglobulin antibody levels measurement). Both types of recurrence will be classified as an outcome.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Quality of life evaluated by SF-36 questionnaire.</measure>
    <time_frame>18 months</time_frame>
    <description>This outcome will be evaluated by SF-36 questionnaire. The Short Form 36 Health Survey Questionnaire (SF-36) is a 36-item scale constructed to survey health status and quality of life and taps eight health concepts: physical functioning, bodily pain, role limitations due to physical health problems, role limitations due to personal or emotional problems, emotional well-being, social functioning, energy/fatigue, and general health perceptions. It also includes a single item that provides an indication of perceived change in health.&#xD;
The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient's satisfaction evaluated by analogue-visual scale from 0 to 10.</measure>
    <time_frame>18 months</time_frame>
    <description>This outcome will be evaluated by analogue-visual scale from 0 to 10.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Health care system access evaluated by the number of procedures related to the DTC performed by the patient.</measure>
    <time_frame>18 months</time_frame>
    <description>This outcome will be evaluated by the number of procedures related to the DTC performed by the patient.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hypothyroidism control evaluated by the TSH level during the follow-up of the patients.</measure>
    <time_frame>18 months</time_frame>
    <description>This outcome will be evaluated by the TSH level during the follow-up of the patients.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">472</enrollment>
  <condition>Differentiated Thyroid Cancer</condition>
  <arm_group>
    <arm_group_label>Usual care</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The patients will remain in care at the HCPA thyroid disease outpatient clinic during the study period. This follow-up will be done by endocrinologists, and the patients will undergo clinical, biochemical (TSH, thyroglobulin, and antithyroglobulin) and radiological (cervical ultrasound) tests to seek disease recurrence. The patient's consultation will be done one or twice a year.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Telehealth</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The patients will be discharged from the HCPA thyroid disease outpatient clinic, being instructed to seek the primary care level according to their place of residence to schedule a routine consultation in up to six months.&#xD;
After 45 days after the estimated date of the consultation (6 months after discharge), the Telehealth staff will contact the patient to check if the consultation was actually performed. When individuals report difficulty accessing the unit, contact will be made to the primary care teams and the Telehealth staff will schedule the appointment. A new contact will be made in 12 months to verify if the consultation was actually performed.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Telehealth</intervention_name>
    <description>After 45 days after the estimated date of the consultation (6 months after discharge), the Telehealth staff will contact the patient to check if the consultation was actually performed. When individuals report difficulty accessing the unit, contact will be made to the primary care teams and the Telehealth staff will schedule the appointment. A new contact will be made in 12 months to verify if the consultation was actually performed.</description>
    <arm_group_label>Telehealth</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Usual care</intervention_name>
    <description>The patients will remain in care at the HCPA thyroid disease outpatient clinic during the study period. This follow-up will be done by endocrinologists, and the patients will undergo clinical, biochemical (TSH, thyroglobulin, and antithyroglobulin) and radiological (cervical ultrasound) tests to seek disease recurrence. The patient's consultation will be done one or twice a year.</description>
    <arm_group_label>Usual care</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with diagnostic of differentiated thyroid cancer and an excellent response to&#xD;
             the initial treatment.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Definitive postoperative hypoparathyroidism.&#xD;
&#xD;
          -  Postoperative vocal cord paralysis requiring tracheostomy.&#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>Rafael S. Scheffel, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hospital de Clínicas de Porto Alegre</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hospital de Clínicas de Porto Alegre</name>
      <address>
        <city>Porto Alegre</city>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <verification_date>March 2023</verification_date>
  <study_first_submitted>December 28, 2018</study_first_submitted>
  <study_first_submitted_qc>January 4, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 7, 2019</study_first_posted>
  <last_update_submitted>March 6, 2023</last_update_submitted>
  <last_update_submitted_qc>March 6, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">March 7, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Follow-up</keyword>
  <keyword>Telehealth</keyword>
  <keyword>Recurrence</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>Undecided</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/NCT03794375
org study id: 95392418300005327
nct id: NCT03794375
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Introduction: Differentiated thyroid cancer (DTC) is the most common endocrine malignancy. It
      presents low recurrence rates (2-5%) and the consensus of DTC recommends long-term follow-up,
      without a definition of maximum follow-up time. The use of Telehealth is a strategy that aims
      to optimize the transition of care for patients from tertiary care to primary health care,
      helping to follow up these patients.

      Objective: To evaluate the impact of the care transition between specialized care and primary
      health care of patients with DTC using telemedicine solutions.

      Design / Patients: Randomized clinical trial. Patients with DTC with excellent response
      (without evidence of disease) after initial treatment.

      Interventions / Outcomes: Patients will be randomized to follow-up in face-to-face
      consultations in tertiary care or transfer of care to primary care with support from the
      Telehealth Center of Rio Grande do Sul. After 18 months, all patients will be evaluated, the
      primary outcome being DTC recurrence rate. Outcomes related to quality of life and use of the
      health system will also be evaluated. Both follow-up strategies are expected to be
      equivalent, making it possible to optimize the use of the health system.
Differentiated thyroid cancer (DTC) is the most frequent malignant neoplasm of the endocrine
      system, accounting for approximately 95% of the cases of carcinomas in this system. DTC is
      considered to be an indolent behavioral neoplasm with low rates of morbidity and mortality
      (mean survival in 10 years from 93 to 98%), being one of the malignancies with a greater
      chance of cure.

      In recent years, the use of the initial treatment response, called "dynamic risk
      classification", has been advocated in order to better estimate the risk of unfavorable
      outcomes in patients with DTC. Using this classification, the recurrence rate in the
      contemporary CDT cohorts has been shown to be very low, at a household of 1-5%. In a cohort
      of our center, which evaluated 786 patients, the recurrence rate in the group of 357 patients
      classified as excellent response after the initial treatment was 2.8%, and none of these
      patients presented structural relapse (median follow-up of 4 years). Thus, it is possible to
      affirm that most of the patients classified as having an excellent response after initial
      treatment are permanently free of disease. However, the main consensus on the management of
      DTC recommends long-term follow-up, not defining the maximum follow-up time. This follow-up
      consists of consultations in specialized centers (preferably with endocrinologists),
      laboratory tests (TSH, thyroglobulin and antithyroglobulin antibody) and imaging.

      In Brazil, the health network is characterized by the heterogeneity of hospital structures
      regarding the incorporation of technologies and service complexity, with a concentration of
      financial resources and specialized personnel in large cities and regional imbalance. Within
      this context, specialized outpatients with high complexity face overcrowding (of patients
      already under follow-up) and restricted access (to patients in need of follow-up). In this
      sense, transferring the care of follow-up patients in specialized hospitals to primary care
      level in their place of origin to maintain follow-up brings benefits to individuals and the
      system as a whole. The structure of referral of patients to the different levels of care in
      the Brazilian public health system occurs through the reference and counter-referral system,
      a fundamental point to guarantee the accessibility, universality, and integrality of care. It
      is understood as a counter-referral to a primary care level, with a lower degree of
      complexity, and should be the health unit closest to the patient's home. Facilitating
      mechanisms of reference and counter-reference processes are fundamental to guarantee the
      principle of integrality, adequate patient care and rational use of resources.

      One of the formats for developing health care support and continuing education activities are
      teleconsulting, which are consultations recorded and performed among workers, health
      professionals and managers, through telecommunication instruments, with the purpose of
      clarifying doubts about clinical procedures, health actions and issues related to the work
      process. It is known that this type of systematic intervention based on practice is one of
      the most effective ways to promote permanent health education. The use of telehealth, through
      teleconsulting, for cases referred by primary care physicians to tertiary services is a
      strategy that aims to qualify and reduce referral lists for other medical professionals.
      Likewise, the use of telehealth emerges as a counter-referral strategy for patients already
      served by tertiary care for primary care units, ensuring patient and physician security of
      adequate management and assisted return for tertiary care, when necessary.

      In this study, 472 patients with a diagnosis of DTC consecutively attended at the thyroid
      clinic of the Hospital de Clínicas of Porto Alegre and who presented excellent response to
      the initial treatment will be invited to participate in the study, and then randomized to two
      follow-up strategies:

        1. Control group: patients will remain in care at the HCPA thyroid disease outpatient
           clinic;

        2. Intervention group: outpatient discharge with telehealth support.

      Patients with definitive postoperative hypoparathyroidism and/or postoperative vocal cord
      paralysis requiring tracheostomy will be excluded. All patients will be evaluated by the
      study team after completing 18 of follow-up. Clinical, laboratory (TSH, thyroglobulin and
      antithyroglobulin antibody) and imaging (cervical ultrasonography) for DTC relapse will be
      evaluated in this follow-up visit. The primary endpoint will be the DTC recurrence rate. This
      will be divided into biochemistry (when there are only signs of disease in laboratory tests)
      and structural (when demonstrated by clinical or imaging examination). Outcomes related to
      quality of life and use of the health system will also be evaluated. Both follow-up
      strategies are expected to be equivalent in relation to DTC recurrences, potentially enabling
      optimization of the use of the health system.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: None (Open Label)
measure: Recurrence rate
time frame: 18 months
description: All patients will be evaluated by the study team after completing 18 months of follow-up for this outcome. The presence of recurrence may be identified as a structural disease (evaluated by clinical examination and cervical ultrasound) or biochemical (evaluated by laboratory tests -thyroglobulin and antithyroglobulin antibody levels measurement). Both types of recurrence will be classified as an outcome.
measure: Quality of life evaluated by SF-36 questionnaire.
time frame: 18 months
description: This outcome will be evaluated by SF-36 questionnaire. The Short Form 36 Health Survey Questionnaire (SF-36) is a 36-item scale constructed to survey health status and quality of life and taps eight health concepts: physical functioning, bodily pain, role limitations due to physical health problems, role limitations due to personal or emotional problems, emotional well-being, social functioning, energy/fatigue, and general health perceptions. It also includes a single item that provides an indication of perceived change in health.
The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.
measure: Patient's satisfaction evaluated by analogue-visual scale from 0 to 10.
time frame: 18 months
description: This outcome will be evaluated by analogue-visual scale from 0 to 10.
measure: Health care system access evaluated by the number of procedures related to the DTC performed by the patient.
time frame: 18 months
description: This outcome will be evaluated by the number of procedures related to the DTC performed by the patient.
measure: Hypothyroidism control evaluated by the TSH level during the follow-up of the patients.
time frame: 18 months
description: This outcome will be evaluated by the TSH level during the follow-up of the patients.
arm group label: Usual care
arm group type: Active Comparator
description: The patients will remain in care at the HCPA thyroid disease outpatient clinic during the study period. This follow-up will be done by endocrinologists, and the patients will undergo clinical, biochemical (TSH, thyroglobulin, and antithyroglobulin) and radiological (cervical ultrasound) tests to seek disease recurrence. The patient's consultation will be done one or twice a year.
arm group label: Telehealth
arm group type: Experimental
description: The patients will be discharged from the HCPA thyroid disease outpatient clinic, being instructed to seek the primary care level according to their place of residence to schedule a routine consultation in up to six months.
After 45 days after the estimated date of the consultation (6 months after discharge), the Telehealth staff will contact the patient to check if the consultation was actually performed. When individuals report difficulty accessing the unit, contact will be made to the primary care teams and the Telehealth staff will schedule the appointment. A new contact will be made in 12 months to verify if the consultation was actually performed.
intervention type: Other
intervention name: Telehealth
description: After 45 days after the estimated date of the consultation (6 months after discharge), the Telehealth staff will contact the patient to check if the consultation was actually performed. When individuals report difficulty accessing the unit, contact will be made to the primary care teams and the Telehealth staff will schedule the appointment. A new contact will be made in 12 months to verify if the consultation was actually performed.
arm group label: Telehealth
intervention type: Other
intervention name: Usual care
description: The patients will remain in care at the HCPA thyroid disease outpatient clinic during the study period. This follow-up will be done by endocrinologists, and the patients will undergo clinical, biochemical (TSH, thyroglobulin, and antithyroglobulin) and radiological (cervical ultrasound) tests to seek disease recurrence. The patient's consultation will be done one or twice a year.
arm group label: Usual care
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Rafael S. Scheffel, MD, PhD
role: Principal Investigator
affiliation: Hospital de Clínicas de Porto Alegre
facility: 
country: Brazil
responsible party type: Sponsor
mesh term: Thyroid Neoplasms
mesh term: Thyroid Diseases
sharing ipd: Undecided