Pre-Clinic Visit Online Education for Thyroid Cancer

N/ANot Yet RecruitingNCT07690839

Cedars-Sinai Medical Center60 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

DOUBLE

Enrollment

Conditions

Thyroid Cancer

Interventions

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.

ACS "After a Thyroid Cancer Diagnosis" FlyerOTHER

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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.

Time frame: Baseline, 1-day post clinic visit, 14-days post clinic visit

Secondary Outcomes

Decisional Conflict Scale

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.

Time frame: 1-day post clinic visit

Shared Decision Making

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.