Pre-Clinic Visit Online Education for Thyroid Cancer
29. August 2026 aktualisiert von: 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.
Studienübersicht
Status
Noch keine Rekrutierung
Bedingungen
Intervention / Behandlung
Studientyp
Interventionell
Einschreibung (Geschätzt)
60
Phase
- Unzutreffend
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienkontakt
- Name: Zoe Krut, MSHS
- Telefonnummer: 310-423-0699
- E-Mail: Zoe.Krut@cshs.org
Studieren Sie die Kontaktsicherung
- Name: Michael Fine, MSHS
- E-Mail: michael.fine@cshs.org
Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
- Erwachsene
- Älterer Erwachsener
Akzeptiert gesunde Freiwillige
Nein
Beschreibung
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
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Versorgungsforschung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Doppelt
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
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.
|
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.
|
|
Schein-Komparator: 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.
|
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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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
TC-MAX
Zeitfenster: 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
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Decisional Conflict Scale
Zeitfenster: 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
|
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Shared Decision Making
Zeitfenster: 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
|
Andere Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
System Usability Scale
Zeitfenster: 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
|
Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Sponsor
Ermittler
- Hauptermittler: Allen Ho, MD, Cedars-Sinai Medical Center
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn (Geschätzt)
1. August 2027
Primärer Abschluss (Geschätzt)
1. Juli 2028
Studienabschluss (Geschätzt)
1. September 2028
Studienanmeldedaten
Zuerst eingereicht
2. Juli 2026
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
2. Juli 2026
Zuerst gepostet (Tatsächlich)
8. Juli 2026
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
1. September 2026
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
29. August 2026
Zuletzt verifiziert
1. August 2026
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- STUDY00004712
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Nein
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Nein
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