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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
100 Years
Healthy volunteers
No
Inclusion Criteria:
1. Patients 18 years of age or older
2. Newly diagnosed previously untreated papillary thyroid cancer (PTC) (fine needle aspiration biopsy positive for PTC or suspicious for PTC).
3. PTC must be less than 2 cm in maximal diameter on thyroid ultrasound
4. No evidence of metastatic cervical lymphadenopathy on ultrasound imaging of the neck (or other neck imaging) and no known distant metastatic thyroid cancer.
5. No other absolute indications for thyroid or parathyroid surgery
6. Permission for review of thyroid cancer-related medical records
Exclusion Criteria:
1. Regional or distant metastatic thyroid cancer
2. History of prior thyroid cancer surgery
3. High risk location of the PTC (e.g. adjacent to the recurrent laryngeal nerve or trachea)
4. The patient has clinical signs, imaging, or indirect laryngoscopy findings suggestive of locally advanced thyroid cancer (i.e. vocal cord paralysis or any clinical or radiographic signs of extrathyroidal invasion into adjacent structures such as the strap muscles of the neck, trachea or esophagus)
5. Known or suspected poorly differentiated or non-papillary thyroid cancer
6. Medically unfit for surgery due to co-morbidity
7. Another active malignancy with limited life expectancy of \< 1 year.
8. Pregnancy at the time of study enrollment.
9. Other absolute indication for thyroid or parathyroid surgery
10. Unable to provide informed consent for the study or comply with study follow-up procedures due to current severe active cognitive or psychiatric impairment, substance abuse, or other reasons.
Primary outcome measure(s)
Disease management decision (first part of the study, focused on treatment management choice) — 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) 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 (second part of the study - follow-up of respective active surveillance and surgical patient groups) — 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) Decision regret (total score, self-administered written questionnaire)
Trial sites (1)
Facility
City
Region
Status
University Health Network
Toronto
Ontario
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This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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