Pre-Clinic Visit Online Education for Thyroid Cancer

Официальное название

A Randomized Controlled Trial Evaluating Educational Resources for Patients With Thyroid Cancer

Обзор

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.

Вмешательства

• Поведенческое 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 wit
• Другое 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.

Первичные конечные точки

• TC-MAX [Срок оценки: Baseline, 1-day post clinic visit, 14-days post clinic visit]

Вторичные конечные точки (2)

• Decisional Conflict Scale [Срок оценки: 1-day post clinic visit]
• Shared Decision Making [Срок оценки: 1-day post clinic visit]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Организация здравоохранения

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07690839 · STUDY00004712

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗