Pre-Clinic Visit Online Education for Thyroid Cancer

August 29, 2026 updated by: 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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Newly diagnosed with either:

    1. ≤2cm Bethesda 6 thyroid nodule (papillary thyroid carcinoma) (T1N0)
    2. ≤2cm Bethesda 5 thyroid nodule
    3. ≤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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Behavioral: THRIVE
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.
Sham Comparator: 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.
Other: ACS "After a Thyroid Cancer Diagnosis" Flyer
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
TC-MAX
Time Frame: 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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Decisional Conflict Scale
Time Frame: 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.
1-day post clinic visit
Shared Decision Making
Time Frame: 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

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
System Usability Scale
Time Frame: 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cedars-Sinai Medical Center

Investigators

  • Principal Investigator: Allen Ho, MD, Cedars-Sinai Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

August 1, 2027

Primary Completion (Estimated)

July 1, 2028

Study Completion (Estimated)

September 1, 2028

Study Registration Dates

First Submitted

July 2, 2026

First Submitted That Met QC Criteria

July 2, 2026

First Posted (Actual)

July 8, 2026

Study Record Updates

Last Update Posted (Actual)

September 1, 2026

Last Update Submitted That Met QC Criteria

August 29, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY00004712

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe