Pre-Clinic Visit Online Education for Thyroid Cancer
29 de agosto de 2026 actualizado por: Allen Ho, Cedars-Sinai Medical Center
A Randomized Controlled Trial Evaluating Educational Resources for Patients With Thyroid Cancer
Through a pilot randomized controlled trial (RCT), we aim to test the feasibility and preliminary impact of two online educational resources among adult patients with thyroid cancer.
Each online program can be accessed on the patient's personal device, and will be provided to the patient following a diagnosis of thyroid cancer but before meeting with their surgeon to discuss treatment options.
The goal of the resource is to educate patients on the various treatment options for thyroid cancer prior to surgical consultation, so that clinic visit time can be better utilized to discuss patient questions and priorities, and support shared decision making.
Clinical (TC-MAX; thyroid cancer related anxiety) and behavioral outcomes (decisional conflict, shared-decision making, treatment decision) will be assessed via online surveys 1-day and 14-days post-visit.
Descripción general del estudio
Estado
Aún no reclutando
Condiciones
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Estimado)
60
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: Zoe Krut, MSHS
- Número de teléfono: 310-423-0699
- Correo electrónico: Zoe.Krut@cshs.org
Copia de seguridad de contactos de estudio
- Nombre: Michael Fine, MSHS
- Correo electrónico: michael.fine@cshs.org
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
No
Descripción
Inclusion Criteria:
Newly diagnosed with either:
- ≤2cm Bethesda 6 thyroid nodule (papillary thyroid carcinoma) (T1N0)
- ≤2cm Bethesda 5 thyroid nodule
- ≤2cm Bethesda 3-4 thyroid nodule with molecular testing that confers >75% risk of malignancy
- Able to understand and complete questionnaires independently in English
- Access to an internet-enabled device for online surveys and intervention access
Exclusion Criteria:
- Cognitive impairment or other condition that, in the opinion of the investigators, would interfere with protocol participation
- Has nodule >2cm in size, or with non-papillary thyroid carcinoma histology
- High-grade or poorly differentiated papillary thyroid carcinoma (PTC) variants
- Central or lateral neck lymphadenopathy suspicious for PTC
- Unfavorable nodule location, to be determined by the surgeon (e.g. Near dorsal surface (by recurrent laryngeal nerve); adjacent to trachea (risk of cartilage invasion)
- Recurrent thyroid cancer case
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Investigación de servicios de salud
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: THRIVE
Participants randomized to the THRIVE arm will be sent a link to access the THRIVE portal up to 3 weeks prior to their clinic visit.
The THRIVE modules can take between 20-35 minutes to complete.
Completion of the THRIVE modules prior to the clinic visit will be monitored and confirmed by study staff.
Upon completing the program, a report summarizing the conversation and questions/comments brought up by the patient will be shared with their physician prior to the clinic visit.
|
THRIVE is a tailored AI agent that provides patient education and assists in decision-making specifically for thyroid cancer patients.
Using HIPAA-compliant protocols and an empathic approach, THRIVE can (1) establish patient priorities, (2) guide patients through decision tools, and (3) integrate detailed notes into the electronic health record (EHR).
Such computer-generated notes have been found to be higher quality, more comprehensive, better organized, and with greater relevance compared with physician-documented notes.
Altogether, this solution tackles a time-intensive and laborious task, expanding time and bandwidth for decision-making.
Moreover, integration with existing infrastructure like the EHR can help promote clinical adoption.
|
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Comparador falso: Education Control
Participants randomized to the education control arm will be sent a link to access the 2-page American Cancer Society (ACS) handout: "After a Thyroid Cancer Diagnosis."
The handout can take between 5-15 minutes to read through.
Completion of the ACS handout prior to the clinic visit will be monitored and confirmed by study staff.
|
The 2-page American Cancer Society (ACS) flyer (No. 0827.60 Rev. 3/25) is titled "After a Thyroid Cancer Diagnosis" and provides brief information about "Treatment for thyroid cancer", "What to expect before and during treatment", "What to expect after treatment", "Staying healthy", and "Dealing with your feelings", as well as recommendations on questions to ask a physician for each of the above topics.
The flyer also provides the patient with a link to the ACS website and a direct phone number.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
TC-MAX
Periodo de tiempo: Baseline, 1-day post clinic visit, 14-days post clinic visit
|
Thyroid cancer-related anxiety as measured by the 18-item TC-MAX questionnaire created by Dr. Allen Ho at Cedars-Sinai.
It is a psychometric scale assessing thyroid cancer-related anxiety across three different subscales (Collective Anxiety, Ultrasound Anxiety, and Fear of Recurrence/Progression). Scale range is between 0-100, with higher scores indicating greater anxiety.
Means and standard deviations will be used to describe the scores.
|
Baseline, 1-day post clinic visit, 14-days post clinic visit
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Decisional Conflict Scale
Periodo de tiempo: 1-day post clinic visit
|
Decisional conflict as measured by the 16-item Traditional Decisional Conflict Scale (DCS) - Statement Format.
This scale assesses personal perceptions of uncertainty in choosing options; modifiable factors contributing to uncertainty such as feeling uninformed, unclear about personal values and unsupported in decision making; and effective decision making such as feeling the choice is informed, values-based, likely to be implemented and expressing satisfaction with the choice.
This questionnaire uses a 5-point Likert scale, from strongly agree to strongly disagree.
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1-day post clinic visit
|
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Shared Decision Making
Periodo de tiempo: 1-day post clinic visit
|
Patient perception of shared decision making as measured by the 9-item Shared Decision Making Questionnaire (SDM-Q-9).
This questionnaire measures the extent to which patients are involved in the process of decision-making from the perspective of the patient.
This questionnaire uses a 6-point Likert scale, from completely agree to completely disagree.
|
1-day post clinic visit
|
Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
System Usability Scale
Periodo de tiempo: 1-day post clinic visit
|
System usability as measured by the validated, 10-item System Usability Scale (SUS).
This attitude Likert scale gives a global assessment of usability.
Each item is rated on a scale of 0 to 5, with higher scores indicating greater usability.
|
1-day post clinic visit
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: Allen Ho, MD, Cedars-Sinai Medical Center
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Estimado)
1 de agosto de 2027
Finalización primaria (Estimado)
1 de julio de 2028
Finalización del estudio (Estimado)
1 de septiembre de 2028
Fechas de registro del estudio
Enviado por primera vez
2 de julio de 2026
Primero enviado que cumplió con los criterios de control de calidad
2 de julio de 2026
Publicado por primera vez (Actual)
8 de julio de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
1 de septiembre de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
29 de agosto de 2026
Última verificación
1 de agosto de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- STUDY00004712
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
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