Thyroid Cancer Stage I Clinical Trial
Official title:
Deciding on Active Surveillance as an Alternative Option to Surgery in the Primary Management of Low Risk Papillary Thyroid Cancer
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).
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