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Pre-Clinic Visit Online Education for Thyroid Cancer

29. august 2026 oppdatert av: 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.

Studieoversikt

Status

Har ikke rekruttert ennå

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Antatt)

60

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studer Kontakt Backup

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Beskrivelse

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Helsetjenesteforskning
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Dobbelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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.
Atferdsmessig: 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 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.
Sham-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.
Annen: 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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
TC-MAX
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Decisional Conflict Scale
Tidsramme: 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
Shared Decision Making
Tidsramme: 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

Andre resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
System Usability Scale
Tidsramme: 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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Cedars-Sinai Medical Center

Etterforskere

  • Hovedetterforsker: Allen Ho, MD, Cedars-Sinai Medical Center

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

1. august 2027

Primær fullføring (Antatt)

1. juli 2028

Studiet fullført (Antatt)

1. september 2028

Datoer for studieregistrering

Først innsendt

2. juli 2026

Først innsendt som oppfylte QC-kriteriene

2. juli 2026

Først lagt ut (Faktiske)

8. juli 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

1. september 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

29. august 2026

Sist bekreftet

1. august 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • STUDY00004712

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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