Biopsy vs. Active MonitoringTRAIL Study: Feasibility and Pilot

Inclusion Criteria:

• Participants must be ≥18 years of age.
• Participants must be able and willing to provide informed consent or have a surrogate capable of providing same.
• Participants must be absent of symptoms referable to the nodule: dysphagia or nodule physically visible and/or bothersome to patient.
• Participants' thyroid nodule must have a TI-RADS rating of 4 or 5.
• Participants thyroid nodule must be ≤2 cm in largest diameter.
• Participants must be being considered for biopsy.
• Participants with a prior history of papillary thyroid cancer are eligible.

Exclusion Criteria:

Patients who fall into one of the following categories will NOT be eligible for this study:

• Adults who are unable to provide informed consent.
• Patients for whom biopsy is not a consideration.
• Patients with a prior history of thyroid cancer other than papillary thyroid cancer.
• Patients with a history of radiation to the neck.
• Patients who are athyroidal (thyroid gland has been removed or patient has only lingual thyroid tissue).
• Patients who have ultrasound evidence of one or more of the following:
• Airway invasion of the nodule.
• Nodule adjacency to/invading the recurrent nerve.
• Extra-thyroidal invasion by the nodule.
• Patients who have metastasis to cervical lymph nodes (confirmed by needle biopsy if ultrasound suspicious), distant metastases, if identified) testing not required, not usual care)
• Patients who have already had a biopsy of the nodule being considered for inclusion in the study.

TRAIL Pilot Integrated QRI: Inclusion/Exclusion Criteria

Inclusion Criteria for Study Patient Participants:

• Participants must meet the eligibility requirements above and will be or have been approached about enrolling in the pilot study.
• Participants must be willing to allow audio recorder presence and / or willing to be interviewed by the QRI team.

Exclusion Criteria for Study Patient Participants:

-Patients who are not willing to allow audio recorder presence and/or not willing to be interviewed by QRI team will be excluded from this study.

Inclusion Criteria for Study Staff Participants:

• Staff must be willing to audio record their communications with patients about enrolling in the study.
• Staff must be willing to participate in interviews with QRI team about their views of the study.

Exclusion Criteria for Study Staff Participants:

-Staff members who are not willing to participate in audio taping of recruitment discussions and/or interviews with QRI team about their views of the study will be excluded.