Pre-Clinic Visit Online Education for Thyroid Cancer
2026년 8월 29일 업데이트: 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.
연구 개요
연구 유형
중재적
등록 (추정된)
60
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
- 이름: Zoe Krut, MSHS
- 전화번호: 310-423-0699
- 이메일: Zoe.Krut@cshs.org
연구 연락처 백업
- 이름: Michael Fine, MSHS
- 이메일: michael.fine@cshs.org
참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
아니
설명
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
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 건강 서비스 연구
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: 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.
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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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가짜 비교기: 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.
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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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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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TC-MAX
기간: Baseline, 1-day post clinic visit, 14-days post clinic visit
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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.
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Baseline, 1-day post clinic visit, 14-days post clinic visit
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Decisional Conflict Scale
기간: 1-day post clinic visit
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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
기간: 1-day post clinic visit
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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.
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1-day post clinic visit
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기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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System Usability Scale
기간: 1-day post clinic visit
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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.
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1-day post clinic visit
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 수석 연구원: Allen Ho, MD, Cedars-Sinai Medical Center
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (추정된)
2027년 8월 1일
기본 완료 (추정된)
2028년 7월 1일
연구 완료 (추정된)
2028년 9월 1일
연구 등록 날짜
최초 제출
2026년 7월 2일
QC 기준을 충족하는 최초 제출
2026년 7월 2일
처음 게시됨 (실제)
2026년 7월 8일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 9월 1일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 8월 29일
마지막으로 확인됨
2026년 8월 1일
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .