<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/NCT03271892</url>
  </required_header>
  <id_info>
    <org_study_id>15-8942</org_study_id>
    <nct_id>NCT03271892</nct_id>
  </id_info>
  <brief_title>Deciding on Active Surveillance or Surgery for Primary Management of Low Risk Papillary Thyroid Cancer</brief_title>
  <acronym>AS-PTC</acronym>
  <official_title>Deciding on Active Surveillance as an Alternative Option to Surgery in the Primary Management of Low Risk Papillary Thyroid Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Health Network, Toronto</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Ontario Ministry of Health and Long Term Care</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Canadian Cancer Society (CCS)</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University Health Network, Toronto</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>
      This is a prospective observational study.&#xD;
&#xD;
        1. In the first part of the study, consenting eligible adult patients with low risk&#xD;
           papillary thyroid cancer that is confined to the thyroid, are provided verbal and&#xD;
           written information about their disease and the option of active surveillance (close&#xD;
           monitoring with intention to treat if disease progresses or if the patient changes&#xD;
           her/his mind), as an alternative to thyroid surgery (thyroidectomy - traditional&#xD;
           standard of care). Patients are free to make their own disease management choice (ie.&#xD;
           active surveillance or thyroidectomy) and the investigators are examining how often&#xD;
           patients choose each of these options. The investigators are also examining the reasons&#xD;
           for their choice.&#xD;
&#xD;
        2. In the second part of the study, consenting, eligible patients who completed the&#xD;
           preceding part of the study and chose either a) active surveillance, or b) thyroid&#xD;
           surgery, are tracked with respect to clinical and psychosocial outcomes as well as&#xD;
           quality of life. Patients who chose active surveillance are free to change their mind&#xD;
           and have surgery at any point, even if the disease does not progress. The primary study&#xD;
           outcome is decision regret at one year, in the respective groups of patients who chose&#xD;
           active surveillance or thyroidectomy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a prospective observational study, consisting of multiple parts.&#xD;
&#xD;
        1. In the first part of the study, eligible, consenting adult patients with low risk&#xD;
           papillary thyroid cancer who have not had thyroid surgery, are provided with verbal and&#xD;
           written information about the disease prognosis, surgical treatment outcomes, and the&#xD;
           option of active surveillance (close monitoring with the intention of treatment if there&#xD;
           is disease progression or if the patient changes her/his mind), as an alternative to&#xD;
           immediately proceeding with thyroidectomy. The primary outcome of this part of the study&#xD;
           is the final disease management decision of the patient (ie. active surveillance or&#xD;
           thyroid surgery) and we are also examining patients' reasons for their choice.&#xD;
&#xD;
        2. In the second part of this study, eligible consenting patients who completed the&#xD;
           preceding part of the study and chose either: a) active surveillance, or b) thyroid&#xD;
           surgery, are tracked with respect to disease, treatment, psychosocial outcomes, and&#xD;
           quality of life. For patients under active surveillance, clinical follow-up is conducted&#xD;
           at a participating study institution. For patients who choose surgery, surgery and&#xD;
           related clinical follow-up may be performed at any institution (of the patient's&#xD;
           choice), however, the thyroid cancer-related medical records are regularly reviewed.&#xD;
           Questionnaires are mailed to patients at one year. The primary outcome for this study is&#xD;
           decision regret (on the decision for active surveillance or surgery) at one year after&#xD;
           initiating the disease management decision (ie. active surveillance or surgery). As the&#xD;
           decision for surgery or active surveillance is up to the patient and the proportion of&#xD;
           patients in each group is unknown, the results in respective groups will be reported&#xD;
           separately for the primary analysis (and only compared if sufficient numbers are&#xD;
           available in each group).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">May 11, 2016</start_date>
  <completion_date type="Anticipated">December 31, 2026</completion_date>
  <primary_completion_date type="Anticipated">May 11, 2026</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Disease management decision (first part of the study, focused on treatment management choice)</measure>
    <time_frame>0 to 3 months after enrollment in the study (as it is expected that the disease management decision should be completed within that time frame)</time_frame>
    <description>In the first part of the study, at any time point after study enrollment and receiving written and verbal information about disease prognosis and the option of active surveillance, patients will be asked to provide a final disease management decision (active surveillance or surgery). This decision should be generally finalized within 3 months of enrollment in the study.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Decision regret (second part of the study - follow-up of respective active surveillance and surgical patient groups)</measure>
    <time_frame>1 year after enrolling in the second phase of the study (i.e. one year after enrolling in the active surveillance arm or 1 year after the first thyroid cancer surgery)</time_frame>
    <description>Decision regret (total score, self-administered written questionnaire)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Disease management decision rationale/explanation</measure>
    <time_frame>0 to 3 months after enrollment in the study, once the decision on disease management is finalized (it is expected that the disease management decision should be completed within the time frame of 0 to 3 months)</time_frame>
    <description>Patients will be asked the reason for choosing active surveillance or surgery once final decision is complete for the disease management plan (i.e. active surveillance or surgery). Each patient will be asked, in a semi-structured interview question, to explain the reason why the disease management strategy that was chosen. The results will be coded and analyzed using a mixed methods approach.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Disease management decision-maker identification</measure>
    <time_frame>0 to 3 months after enrollment in the study, once the decision on disease management is finalized (it is expected that the disease management decision should be completed within the time frame of 0 to 3 months)</time_frame>
    <description>Patients will be asked about the extent of their involvement in disease management decision-making</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Disease management decision satisfaction</measure>
    <time_frame>0 to 3 months after enrollment in the study, once the decision on disease management is finalized (it is expected that the disease management decision should be completed within the time frame of 0 to 3 months)</time_frame>
    <description>Satisfaction with decision scale (overall score)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Baseline coping mechanisms in all patients and respective study groups</measure>
    <time_frame>Within 1 month of study enrollment (baseline interview after enrollment in the study, prior to being provided detailed information about active surveillance)</time_frame>
    <description>Brief Cope Questionnaire (description of all respective subscales per the questionnaire developer)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Baseline evaluation of fear of disease progression in all patients and respective study groups (i.e. those who ultimately choose active surveillance or surgery)</measure>
    <time_frame>Within 1 month of study enrollment (baseline interview after enrollment in the study, prior to being provided detailed information about active surveillance)</time_frame>
    <description>Short form of the Fear of Progression Questionnaire (overall score)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fear of disease progression at 1 year follow-up - in respective study groups (active surveillance or surgery)</measure>
    <time_frame>1 year after enrolling in the second phase of the study (i.e. one year after enrolling in the active surveillance arm or 1 year after the first thyroid cancer surgery)</time_frame>
    <description>Short form of the Fear of Progression Questionnaire (overall score)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Baseline evaluation of surgical fear in all patients and respective study groups (i.e. those who ultimately choose active surveillance or surgery)</measure>
    <time_frame>Within 1 month of study enrollment (baseline interview after enrollment in the study, prior to being provided detailed information about active surveillance)</time_frame>
    <description>Surgical Fear Questionnaire (total score)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Baseline evaluation of decision self-efficacy in all patients and respective study groups (i.e. those who ultimately choose active surveillance or surgery)</measure>
    <time_frame>Within 1 month of study enrollment (baseline interview after enrollment in the study, prior to being provided detailed information about active surveillance)</time_frame>
    <description>Decision Self-Efficacy Scale (total score)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Psychological distress at 1 year in respective study groups</measure>
    <time_frame>1 year after enrolling in the second phase of the study (i.e. one year after enrolling in the active surveillance arm or 1 year after the first thyroid cancer surgery)</time_frame>
    <description>Hospital Anxiety and Depression Scale (respective total scores for anxiety and depression, respectively)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Disease-specific quality of life at 1 year</measure>
    <time_frame>1 year after enrolling in the second phase of the study (i.e. one year after enrolling in the active surveillance arm or 1 year after the first thyroid cancer surgery)</time_frame>
    <description>M.D. Anderson Symptom Inventory (respective Symptom Severity and Symptom Interference with life - respective total scores for these subscales)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Body image perception at 1 year</measure>
    <time_frame>1 year after enrolling in the second phase of the study (i.e. one year after enrolling in the active surveillance arm or 1 year after the first thyroid cancer surgery)</time_frame>
    <description>Body Image Scale (overall score)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Thyroid cancer surgery in patients who initially choose active surveillance</measure>
    <time_frame>From date of enrollment in the active surveillance arm of the study until the date of first documented thyroid cancer surgery or date of death from any cause, whichever comes first, assessed up to 10 years from active surveillance arm study enrollment</time_frame>
    <description>The number and percent of patients who initially choose active surveillance, but go on to have surgery (with surgical indication) will be evaluated yearly</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Disease progression</measure>
    <time_frame>From date of enrollment in the active surveillance or surgical arms of the study until the date of first documented thyroid cancer structural disease progression or death from any cause, whichever comes first, assessed up to 10 years from enrollment</time_frame>
    <description>Structural disease progression (Defined as follows: primary tumor growth &gt;3 mm in largest diameter in the active surveillance group, or new metastatic disease in either the active surveillance or surgical group, or newly diagnosed thyroid cancer in the thyroid bed/remaining thyroid lobe in the surgical group)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Thyroid surgical complications</measure>
    <time_frame>From date of enrollment in the active surveillance or surgical arms of the study until the date of any documented thyroid cancer surgical complication or death from any cause, whichever comes first, assessed up to 10 years from enrollment</time_frame>
    <description>Any thyroid surgical complications (defined as hypoparathyroidism, recurrent laryngeal nerve injury, or other surgical complications documented in the medical record) will be ascertained in all patients from either group, who undergo thyroid surgery</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>New chronic prescription thyroid hormone use</measure>
    <time_frame>From date of enrollment in the active surveillance or surgical arms of the study until the date of first documented prescription thyroid hormone use or death from any cause, whichever comes first, assessed up to 10 years from enrollment</time_frame>
    <description>New chronic prescription thyroid hormone use will be ascertained in both study arms. Individuals who are taking chronic prescription thyroid hormone prior to enrollment in the study will be excluded from this analysis.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Healthcare resource utilization</measure>
    <time_frame>From the date of enrollment until death from any cause or up to 10 years from enrollment</time_frame>
    <description>Thyroid cancer or thyroid cancer care-related expenses/procedures will be ascertained in both study arms including thyroid cancer surgery, thyroid hormone use, thyroid cancer-related diagnostic testing [bloodwork, imaging], thyroid biopsies, other thyroid cancer-related procedures, thyroid cancer-related specialist healthcare provider visits, radioactive iodine treatment or scans, use of recombinant human thyrotropin, or healthcare expenditures for treatments of complications of thyroid surgery [e.g. prescription treatments for hypoparathyroidism]).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Serum thyroglobulin measurement in the active surveillance group</measure>
    <time_frame>Upon enrollment in the active surveillance arm of the study and thereafter every 6 months for 2 years, and thereafter yearly, for up to 10 years, for patients in the active surveillance arm of the study (who do not have surgery)</time_frame>
    <description>Serum thyroglobulin (with thyroglobulin antibody) measurement</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">200</enrollment>
  <condition>Thyroid Cancer Stage I</condition>
  <arm_group>
    <arm_group_label>Active surveillance</arm_group_label>
    <description>Patients under active surveillance choose to not have immediate thyroidectomy. Patients are closely monitored with respect to clinical status, ultrasound imaging, biochemical indices (thyroid function, thyroglobulin, and thyroglobulin antibodies) and any thyroid cancer-related treatments (if needed). Active surveillance is conducted at a participating study site. Criteria defining disease progression are established, and if such criteria are met, thyroid surgery is recommended to the patient. However, patients are free to choose to have thyroid surgery at any time, in the absence of disease progression. Thyroid cancer clinical and treatment outcomes are tracked by the study team.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Immediate Surgery</arm_group_label>
    <description>Patients who choose surgery, undergo thyroidectomy, as per current standards of care, by a surgeon of their choice in an institution of their choice. The treating surgeon, in discussion with the patient, will choose the extent of thyroid surgery that may be appropriate for the individual case. Post-surgical follow-up is per the discretion of the treating surgeon, endocrinologist, or other healthcare providers involved in the patient's thyroid cancer care. Thyroid cancer clinical and treatment outcomes are tracked by the study team.</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Consenting individuals aged 18 years of age or older with papillary thyroid cancer (PTC)&#xD;
        who have a primary tumor that is &lt;2cm in maximal diameter, and fine needle aspiration&#xD;
        biopsy is positive or suspicious for PTC. The tumor must be confined to the thyroid (no&#xD;
        metastatic disease) and not considered in a high risk location (e.g. adjacent to the&#xD;
        recurrent laryngeal nerve or trachea). The patient must have no prior surgical treatment&#xD;
        for thyroid cancer.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Patients 18 years of age or older&#xD;
&#xD;
          2. Newly diagnosed previously untreated papillary thyroid cancer (PTC) (fine needle&#xD;
             aspiration biopsy positive for PTC or suspicious for PTC).&#xD;
&#xD;
          3. PTC must be less than 2 cm in maximal diameter on thyroid ultrasound&#xD;
&#xD;
          4. No evidence of metastatic cervical lymphadenopathy on ultrasound imaging of the neck&#xD;
             (or other neck imaging) and no known distant metastatic thyroid cancer.&#xD;
&#xD;
          5. No other absolute indications for thyroid or parathyroid surgery&#xD;
&#xD;
          6. Permission for review of thyroid cancer-related medical records&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Regional or distant metastatic thyroid cancer&#xD;
&#xD;
          2. History of prior thyroid cancer surgery&#xD;
&#xD;
          3. High risk location of the PTC (e.g. adjacent to the recurrent laryngeal nerve or&#xD;
             trachea)&#xD;
&#xD;
          4. The patient has clinical signs, imaging, or indirect laryngoscopy findings suggestive&#xD;
             of locally advanced thyroid cancer (i.e. vocal cord paralysis or any clinical or&#xD;
             radiographic signs of extrathyroidal invasion into adjacent structures such as the&#xD;
             strap muscles of the neck, trachea or esophagus)&#xD;
&#xD;
          5. Known or suspected poorly differentiated or non-papillary thyroid cancer&#xD;
&#xD;
          6. Medically unfit for surgery due to co-morbidity&#xD;
&#xD;
          7. Another active malignancy with limited life expectancy of &lt; 1 year.&#xD;
&#xD;
          8. Pregnancy at the time of study enrollment.&#xD;
&#xD;
          9. Other absolute indication for thyroid or parathyroid surgery&#xD;
&#xD;
         10. Unable to provide informed consent for the study or comply with study follow-up&#xD;
             procedures due to current severe active cognitive or psychiatric impairment, substance&#xD;
             abuse, or other reasons.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>100 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Anna M Sawka, MD,PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Health Network, Toronto</affiliation>
  </overall_official>
  <overall_official>
    <last_name>David P Goldstein, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Health Network, Toronto</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Ogemdi Ihekire</last_name>
    <phone>416-340-4800</phone>
    <phone_ext>2601</phone_ext>
    <email>ogemdi.ihekire@uhn.ca</email>
  </overall_contact>
  <location>
    <facility>
      <name>University Health Network</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M5G 2C4</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Ogemdi Ihekire</last_name>
      <phone>416-340-4800</phone>
      <phone_ext>2601</phone_ext>
      <email>ogemdi.ihekire@uhn.ca</email>
    </contact>
    <investigator>
      <last_name>Anna M Sawka, MD, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>David P Goldstein, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Sangeet Ghai, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>University Health Network</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M5G 2C4</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Annie M Sawka, MD</last_name>
      <phone>(416) 340-4800</phone>
      <phone_ext>3678</phone_ext>
      <email>Annie.Sawka@uhn.ca</email>
    </contact>
    <contact_backup>
      <last_name>David P Goldstein, MD</last_name>
      <phone>(416) 340-3062</phone>
      <email>David.Goldstein@uhn.ca</email>
    </contact_backup>
    <investigator>
      <last_name>Annie M Sawka, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>David P Goldstein, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Sangeet Ghai, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <link>
    <url>https://bmjopen.bmj.com/content/bmjopen/8/4/e020298.full.pdf</url>
    <description>Protocol manuscript - PMID: 29654030</description>
  </link>
  <link>
    <url>http://thyroidcancerstudy.ca</url>
    <description>Study website</description>
  </link>
  <reference>
    <citation>Sawka AM, Ghai S, Yoannidis T, Rotstein L, Gullane PJ, Gilbert RW, Pasternak JD, Brown DH, Eskander A, Almeida JR, Irish JC, Higgins K, Enepekides DJ, Monteiro E, Banerjee A, Shah M, Gooden E, Zahedi A, Korman M, Ezzat S, Jones JM, Rac VE, Tomlinson G, Stanimirovic A, Gafni A, Baxter NN, Goldstein DP. A Prospective Mixed-Methods Study of Decision-Making on Surgery or Active Surveillance for Low-Risk Papillary Thyroid Cancer. Thyroid. 2020 Jul;30(7):999-1007. doi: 10.1089/thy.2019.0592. Epub 2020 Apr 8.</citation>
    <PMID>32126932</PMID>
  </reference>
  <verification_date>September 2020</verification_date>
  <study_first_submitted>August 28, 2017</study_first_submitted>
  <study_first_submitted_qc>August 31, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 5, 2017</study_first_posted>
  <last_update_submitted>September 22, 2020</last_update_submitted>
  <last_update_submitted_qc>September 22, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">September 24, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>papillary thyroid cancer</keyword>
  <keyword>thyroidectomy</keyword>
  <keyword>active surveillance</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Thyroid Neoplasms</mesh_term>
    <mesh_term>Thyroid Cancer, Papillary</mesh_term>
    <mesh_term>Thyroid Diseases</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
    <ipd_description>We are in discussions with other groups doing active surveillance research, and in future, may share data with such groups. Final plan not yet established.</ipd_description>
  </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/NCT03271892
org study id: 15-8942
nct id: NCT03271892
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This is a prospective observational study.

        1. In the first part of the study, consenting eligible adult patients with low risk
           papillary thyroid cancer that is confined to the thyroid, are provided verbal and
           written information about their disease and the option of active surveillance (close
           monitoring with intention to treat if disease progresses or if the patient changes
           her/his mind), as an alternative to thyroid surgery (thyroidectomy - traditional
           standard of care). Patients are free to make their own disease management choice (ie.
           active surveillance or thyroidectomy) and the investigators are examining how often
           patients choose each of these options. The investigators are also examining the reasons
           for their choice.

        2. In the second part of the study, consenting, eligible patients who completed the
           preceding part of the study and chose either a) active surveillance, or b) thyroid
           surgery, are tracked with respect to clinical and psychosocial outcomes as well as
           quality of life. Patients who chose active surveillance are free to change their mind
           and have surgery at any point, even if the disease does not progress. The primary study
           outcome is decision regret at one year, in the respective groups of patients who chose
           active surveillance or thyroidectomy.
This is a prospective observational study, consisting of multiple parts.

        1. In the first part of the study, eligible, consenting adult patients with low risk
           papillary thyroid cancer who have not had thyroid surgery, are provided with verbal and
           written information about the disease prognosis, surgical treatment outcomes, and the
           option of active surveillance (close monitoring with the intention of treatment if there
           is disease progression or if the patient changes her/his mind), as an alternative to
           immediately proceeding with thyroidectomy. The primary outcome of this part of the study
           is the final disease management decision of the patient (ie. active surveillance or
           thyroid surgery) and we are also examining patients' reasons for their choice.

        2. In the second part of this study, eligible consenting patients who completed the
           preceding part of the study and chose either: a) active surveillance, or b) thyroid
           surgery, are tracked with respect to disease, treatment, psychosocial outcomes, and
           quality of life. For patients under active surveillance, clinical follow-up is conducted
           at a participating study institution. For patients who choose surgery, surgery and
           related clinical follow-up may be performed at any institution (of the patient's
           choice), however, the thyroid cancer-related medical records are regularly reviewed.
           Questionnaires are mailed to patients at one year. The primary outcome for this study is
           decision regret (on the decision for active surveillance or surgery) at one year after
           initiating the disease management decision (ie. active surveillance or surgery). As the
           decision for surgery or active surveillance is up to the patient and the proportion of
           patients in each group is unknown, the results in respective groups will be reported
           separately for the primary analysis (and only compared if sufficient numbers are
           available in each group).
observational model: Cohort
time perspective: Prospective
measure: Disease management decision (first part of the study, focused on treatment management choice)
time frame: 0 to 3 months after enrollment in the study (as it is expected that the disease management decision should be completed within that time frame)
description: In the first part of the study, at any time point after study enrollment and receiving written and verbal information about disease prognosis and the option of active surveillance, patients will be asked to provide a final disease management decision (active surveillance or surgery). This decision should be generally finalized within 3 months of enrollment in the study.
measure: Decision regret (second part of the study - follow-up of respective active surveillance and surgical patient groups)
time frame: 1 year after enrolling in the second phase of the study (i.e. one year after enrolling in the active surveillance arm or 1 year after the first thyroid cancer surgery)
description: Decision regret (total score, self-administered written questionnaire)
measure: Disease management decision rationale/explanation
time frame: 0 to 3 months after enrollment in the study, once the decision on disease management is finalized (it is expected that the disease management decision should be completed within the time frame of 0 to 3 months)
description: Patients will be asked the reason for choosing active surveillance or surgery once final decision is complete for the disease management plan (i.e. active surveillance or surgery). Each patient will be asked, in a semi-structured interview question, to explain the reason why the disease management strategy that was chosen. The results will be coded and analyzed using a mixed methods approach.
measure: Disease management decision-maker identification
time frame: 0 to 3 months after enrollment in the study, once the decision on disease management is finalized (it is expected that the disease management decision should be completed within the time frame of 0 to 3 months)
description: Patients will be asked about the extent of their involvement in disease management decision-making
measure: Disease management decision satisfaction
time frame: 0 to 3 months after enrollment in the study, once the decision on disease management is finalized (it is expected that the disease management decision should be completed within the time frame of 0 to 3 months)
description: Satisfaction with decision scale (overall score)
measure: Baseline coping mechanisms in all patients and respective study groups
time frame: Within 1 month of study enrollment (baseline interview after enrollment in the study, prior to being provided detailed information about active surveillance)
description: Brief Cope Questionnaire (description of all respective subscales per the questionnaire developer)
measure: Baseline evaluation of fear of disease progression in all patients and respective study groups (i.e. those who ultimately choose active surveillance or surgery)
time frame: Within 1 month of study enrollment (baseline interview after enrollment in the study, prior to being provided detailed information about active surveillance)
description: Short form of the Fear of Progression Questionnaire (overall score)
measure: Fear of disease progression at 1 year follow-up - in respective study groups (active surveillance or surgery)
time frame: 1 year after enrolling in the second phase of the study (i.e. one year after enrolling in the active surveillance arm or 1 year after the first thyroid cancer surgery)
description: Short form of the Fear of Progression Questionnaire (overall score)
measure: Baseline evaluation of surgical fear in all patients and respective study groups (i.e. those who ultimately choose active surveillance or surgery)
time frame: Within 1 month of study enrollment (baseline interview after enrollment in the study, prior to being provided detailed information about active surveillance)
description: Surgical Fear Questionnaire (total score)
measure: Baseline evaluation of decision self-efficacy in all patients and respective study groups (i.e. those who ultimately choose active surveillance or surgery)
time frame: Within 1 month of study enrollment (baseline interview after enrollment in the study, prior to being provided detailed information about active surveillance)
description: Decision Self-Efficacy Scale (total score)
measure: Psychological distress at 1 year in respective study groups
time frame: 1 year after enrolling in the second phase of the study (i.e. one year after enrolling in the active surveillance arm or 1 year after the first thyroid cancer surgery)
description: Hospital Anxiety and Depression Scale (respective total scores for anxiety and depression, respectively)
measure: Disease-specific quality of life at 1 year
time frame: 1 year after enrolling in the second phase of the study (i.e. one year after enrolling in the active surveillance arm or 1 year after the first thyroid cancer surgery)
description: M.D. Anderson Symptom Inventory (respective Symptom Severity and Symptom Interference with life - respective total scores for these subscales)
measure: Body image perception at 1 year
time frame: 1 year after enrolling in the second phase of the study (i.e. one year after enrolling in the active surveillance arm or 1 year after the first thyroid cancer surgery)
description: Body Image Scale (overall score)
measure: Thyroid cancer surgery in patients who initially choose active surveillance
time frame: From date of enrollment in the active surveillance arm of the study until the date of first documented thyroid cancer surgery or date of death from any cause, whichever comes first, assessed up to 10 years from active surveillance arm study enrollment
description: The number and percent of patients who initially choose active surveillance, but go on to have surgery (with surgical indication) will be evaluated yearly
measure: Disease progression
time frame: From date of enrollment in the active surveillance or surgical arms of the study until the date of first documented thyroid cancer structural disease progression or death from any cause, whichever comes first, assessed up to 10 years from enrollment
description: Structural disease progression (Defined as follows: primary tumor growth >3 mm in largest diameter in the active surveillance group, or new metastatic disease in either the active surveillance or surgical group, or newly diagnosed thyroid cancer in the thyroid bed/remaining thyroid lobe in the surgical group)
measure: Thyroid surgical complications
time frame: From date of enrollment in the active surveillance or surgical arms of the study until the date of any documented thyroid cancer surgical complication or death from any cause, whichever comes first, assessed up to 10 years from enrollment
description: Any thyroid surgical complications (defined as hypoparathyroidism, recurrent laryngeal nerve injury, or other surgical complications documented in the medical record) will be ascertained in all patients from either group, who undergo thyroid surgery
measure: New chronic prescription thyroid hormone use
time frame: From date of enrollment in the active surveillance or surgical arms of the study until the date of first documented prescription thyroid hormone use or death from any cause, whichever comes first, assessed up to 10 years from enrollment
description: New chronic prescription thyroid hormone use will be ascertained in both study arms. Individuals who are taking chronic prescription thyroid hormone prior to enrollment in the study will be excluded from this analysis.
measure: Healthcare resource utilization
time frame: From the date of enrollment until death from any cause or up to 10 years from enrollment
description: Thyroid cancer or thyroid cancer care-related expenses/procedures will be ascertained in both study arms including thyroid cancer surgery, thyroid hormone use, thyroid cancer-related diagnostic testing [bloodwork, imaging], thyroid biopsies, other thyroid cancer-related procedures, thyroid cancer-related specialist healthcare provider visits, radioactive iodine treatment or scans, use of recombinant human thyrotropin, or healthcare expenditures for treatments of complications of thyroid surgery [e.g. prescription treatments for hypoparathyroidism]).
measure: Serum thyroglobulin measurement in the active surveillance group
time frame: Upon enrollment in the active surveillance arm of the study and thereafter every 6 months for 2 years, and thereafter yearly, for up to 10 years, for patients in the active surveillance arm of the study (who do not have surgery)
description: Serum thyroglobulin (with thyroglobulin antibody) measurement
arm group label: Active surveillance
description: Patients under active surveillance choose to not have immediate thyroidectomy. Patients are closely monitored with respect to clinical status, ultrasound imaging, biochemical indices (thyroid function, thyroglobulin, and thyroglobulin antibodies) and any thyroid cancer-related treatments (if needed). Active surveillance is conducted at a participating study site. Criteria defining disease progression are established, and if such criteria are met, thyroid surgery is recommended to the patient. However, patients are free to choose to have thyroid surgery at any time, in the absence of disease progression. Thyroid cancer clinical and treatment outcomes are tracked by the study team.
arm group label: Immediate Surgery
description: Patients who choose surgery, undergo thyroidectomy, as per current standards of care, by a surgeon of their choice in an institution of their choice. The treating surgeon, in discussion with the patient, will choose the extent of thyroid surgery that may be appropriate for the individual case. Post-surgical follow-up is per the discretion of the treating surgeon, endocrinologist, or other healthcare providers involved in the patient's thyroid cancer care. Thyroid cancer clinical and treatment outcomes are tracked by the study team.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 100 Years
healthy volunteers: No
last name: Anna M Sawka, MD,PhD
role: Principal Investigator
affiliation: University Health Network, Toronto
last name: David P Goldstein, MD, PhD
role: Principal Investigator
affiliation: University Health Network, Toronto
last name: Ogemdi Ihekire
phone: 416-340-4800
phone ext: 2601
email: ogemdi.ihekire@uhn.ca
facility: 
status: Recruiting
contact: 
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status: Recruiting
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country: Canada
url: https://bmjopen.bmj.com/content/bmjopen/8/4/e020298.full.pdf
description: Protocol manuscript - PMID: 29654030
url: http://thyroidcancerstudy.ca
description: Study website
citation: Sawka AM, Ghai S, Yoannidis T, Rotstein L, Gullane PJ, Gilbert RW, Pasternak JD, Brown DH, Eskander A, Almeida JR, Irish JC, Higgins K, Enepekides DJ, Monteiro E, Banerjee A, Shah M, Gooden E, Zahedi A, Korman M, Ezzat S, Jones JM, Rac VE, Tomlinson G, Stanimirovic A, Gafni A, Baxter NN, Goldstein DP. A Prospective Mixed-Methods Study of Decision-Making on Surgery or Active Surveillance for Low-Risk Papillary Thyroid Cancer. Thyroid. 2020 Jul;30(7):999-1007. doi: 10.1089/thy.2019.0592. Epub 2020 Apr 8.
PMID: 32126932
responsible party type: Sponsor
mesh term: Thyroid Neoplasms
mesh term: Thyroid Cancer, Papillary
mesh term: Thyroid Diseases
sharing ipd: Undecided
ipd description: We are in discussions with other groups doing active surveillance research, and in future, may share data with such groups. Final plan not yet established.