None listed
Conditions
Brief summary
Brief description of the study purpose: This study looks at a web based clinical decision support tool, designed to assist clinicians in deciding whether their patient with low risk thyroid cancer is suitable for active surveillance (watch and wait approach). Who is it for? You may be eligible for this study if you are aged 18 years or older, you have been diagnosed with Low Risk Thyroid Cancer. Clinicians who are involved in the management of patients with thyroid cancer will also be eligible to participate and provide their feedback on the web-based clinical support tool. Study details Clinicians will be randomly allocated by a randomisation table created by computer software to one of two groups. Clinicians allocated to the first group (intervention) will receive a link to a clinical decision support tool, where they will be able to use this tool to help determine if their patient with thyroid cancer is suitable for active surveillance. They will discuss this result with their patient and then together the patient and clinician will decide between active surveillance or surgery. Clinicians allocated to the second group (control) will receive a link to an online tool that will not generate a result of whether their patient with thyroid cancer is suitable to undergo active surveillance, but will instead provide information about the outcomes of active surveillance and surgery, They will discuss this with their patient and then together the patient and clinician will decide between active surveillance or surgery. Patients will choose either active surveillance or surgery after discussion with their clinician and all patients will be followed over time to see whether they have evidence of cancer progression. Quality of life in all patients will be assessed via a survey. It is hoped this research will determine whether use of web-based clinical support tool has a positive impact on how clinicians discuss the management options for people with low risk thyroid cancer.
Interventions
Intervention: We have developed a web-based clinical decision support tool that can assist a clinician in identifying whether their patient with low risk thyroid cancer may be appropriate for active surveillance. This tool will collect information then generate a result for the clinician as to whether the patient is suitable for active surveillance, based on the information entered into the tool. The tool will also provide a link to a document containing general information about the outcomes of
Intervention: We have developed a web-based clinical decision support tool that can assist a clinician in identifying whether their patient with low risk thyroid cancer may be appropriate for active surveillance. This tool will collect information then generate a result for the clinician as to whether the patient is suitable for active surveillance, based on the information entered into the tool. The tool will also provide a link to a document containing general information about the outcomes of active surveillance and surgery for treatment of low risk thyroid cancer, to help clinicians discuss these management options with their patients. Clinicians will access the tool that will be provided to them via a web-based link. The study will be open for recruitment for 3 years. The tool will be used in an outpatient clinical setting in the consulting rooms or clinics of participating clinicians. The tool is self-explanatory and does not require any training. It will take approximately 5-10 minutes to input information and generate a result. Each involved study site has signed a clinical trial research agreement indicating they will adhere to the tool. Patient information that will be collected by the tool includes: age, presence of comorbidities that may preclude them from surgical management, patient willingness to consider active surveillance and whether the clinician thinks the patient would be reliable to attend follow up.
Sponsors
Department of Endocrinology, Royal North Shore Hospital
Study design
Allocation
Randomised controlled trial
Primary purpose
Treatment
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Participants will be eligible for inclusion in the study if all of the below are met: • Age 18 or above • Thyroid nodule 2cm or smaller • Bethesda III, V or Bethesda VI result on FNA cytopathology Clinicians will be eligible for inclusion if they are involved in the treatment of patients with thyroid cancer.
Exclusion criteria
Participants will be excluded from study if: • Age <18 • Thyroid nodule >2cm in size • Bethesda result other than BIII, BV or BVI • If they are unable to provide informed consent
Outcome results
None listed