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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.

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.

Ogemdi Ihekire

Anna M Sawka, MD, PhD

David P Goldstein, MD

Sangeet Ghai, MD

Annie M Sawka, MD

Anna M Sawka, MD,PhD

David P Goldstein, MD, PhD

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).

Deciding on Active Surveillance or Surgery for Primary Management of Low Risk Papillary Thyroid Cancer

Deciding on Active Surveillance as an Alternative Option to Surgery in the Primary Management of Low Risk Papillary Thyroid Cancer

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.

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.

Decision regret (total score, self-administered written questionnaire)

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.

Patients will be asked about the extent of their involvement in disease management decision-making

Satisfaction with decision scale (overall score)

Brief Cope Questionnaire (description of all respective subscales per the questionnaire developer)

Short form of the Fear of Progression Questionnaire (overall score)

Surgical Fear Questionnaire (total score)

Decision Self-Efficacy Scale (total score)

Hospital Anxiety and Depression Scale (respective total scores for anxiety and depression, respectively)

M.D. Anderson Symptom Inventory (respective Symptom Severity and Symptom Interference with life - respective total scores for these subscales)

The number and percent of patients who initially choose active surveillance, but go on to have surgery (with surgical indication) will be evaluated yearly

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)

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

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.

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 \[e.g. prescription treatments for hypoparathyroidism\]).

Serum thyroglobulin (with thyroglobulin antibody) measurement

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Deciding on Active Surveillance or Surgery for Primary Management of Low Risk Papillary Thyroid Cancer	NCT03271892	Thyroid Cancer ...		18 Years - 100 Years	University Health Network, Toronto
Deciding on Active Surveillance or Surgery for Primary Management of Low Risk Papillary Thyroid Cancer	NCT03271892	Thyroid Cancer ...		18 Years - 100 Years	University Health Network, Toronto

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