Pre-Clinic Visit Online Education for Thyroid Cancer

NCT07690839 | Not Yet Recruiting DMC

• 1 other identifier: STUDY00004712
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Thyroid Cancer

Keywords

Online Education; Remote Monitoring; Shared Decision Making

Outcome Measures

Primary Outcomes (1)

• TC-MAX

  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 Outcomes (2)

• Decisional Conflict Scale

  1-day post clinic visit

• Shared Decision Making

  1-day post clinic visit

Other Outcomes (1)

• System Usability Scale

  1-day post clinic visit

Study Arms (2)

THRIVE

EXPERIMENTAL

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

Education Control

SHAM COMPARATOR

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

Interventions

THRIVE BEHAVIORAL

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.

THRIVE

ACS "After a Thyroid Cancer Diagnosis" Flyer OTHER

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.

Education Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Cedars-Sinai Medical Center: lead

MeSH Terms

Conditions

Thyroid Neoplasms

Interventions

Nicotine

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Endocrine System Diseases; Thyroid Diseases

Intervention Hierarchy (Ancestors)

Solanaceous Alkaloids; Alkaloids; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring

Study Officials

• Allen Ho, MD

  Cedars-Sinai Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zoe Krut, MSHS

CONTACT

310-423-0699; Zoe.Krut@cshs.org

Michael Fine, MSHS

CONTACT

michael.fine@cshs.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physician

Study Record Dates

• First Submitted: July 2, 2026
• First Posted: July 8, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: July 8, 2026

Record last verified: 2026-07