ThyRoid Active Monitoring and Intervention Longitudinal (TRAIL) Study: Feasibility and Pilot
This is a pilot study to compare two ways of managing newly identified thyroid nodules that are likely to be cancerous based on ultrasound result and which under usual care would undergo immediate biopsy. The main goals of this pilot study are 1) compare anxiety at 6 months in each treatment arm using the validated instrument Anxiety-CA, 2) measure thyroid quality of life in each treatment arm Participants will be randomized to one of two groups: 1. immediate biopsy (usual care) 2. Active monitoring (serial ultrasound based monitoring and close clinical follow-up)
• 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.
• 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.
• 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.