Recruiting

Observational Study

Sponsor:

Thomas Jefferson University

Code:

NCT06918223

Conditions

Thyroid Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Thyroid Informed Surgical Consent Augmenting Video (TISCAV)

Standard Consent

Study Details

Brief summary:

This study looks at how a short educational video can help people better understand thyroid surgery. Patients who have thyroid nodules and need surgery will be part of the study. Some patients will get the usual information from their doctor, while others will also watch a video that explains the surgery in a simple and clear way. The study will check if the video helps patients feel more confident about their decision, lowers anxiety, and helps them remember important information about their surgery. Patients will answer surveys before surgery, after surgery, and 3 months later.

Conditions

Thyroid Cancer

Study ID

NCT06918223

Start date

Nov 10, 2023

Status verified date

Apr, 2025

Completion date

Dec, 2025

Anticipated

Primary completion date

Dec, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria Fluent in English

  • English is Primary Language
  • ≥18 years old at time of consent
  • Eligible for Thyroidectomy, lobectomy, isthmusectomy for any indication

Exclusion Criteria:

  • History of prior thyroid surgery
  • Previously consented for thyroid surgery

Study Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

experimental: Intervention: TISCAV

placebo comparator: Control: Standard Consent

Interventions

Thyroid Informed Surgical Consent Augmenting Video (TISCAV)

Participants randomized to the intervention group will receive a surgeon-created Thyroid Informed Surgical Consent Augmenting Video (TISCAV). This 8-minute video includes animated visuals and a surgeon voiceover explaining thyroid anatomy, surgical options (lobectomy vs. total thyroidectomy), risks, benefits, and expectations. The TISCAV was designed and reviewed by an endocrine surgery team to improve patient comprehension, confidence, satisfaction, and reduce decision regret compared to standard verbal consent alone.

Standard Consent

Participants receiving the Standard Consent intervention will undergo the routine informed consent process for thyroid surgery provided by their surgeon. This process includes a verbal discussion covering thyroidectomy procedure details, potential risks and complications, benefits, alternatives such as active surveillance, and an opportunity to ask questions.

Primary outcome measure

  • Patient knowledge score using a 10-item internally validated Thyroid Surgery Knowledge Assessment [ Time Frame: Immediately after study enrollment (pre-consent) and immediately following the surgical consent process (post-consent) ]
  • Decisional Conflict Score using the Decisional Conflict Scale (DCS) [ Time Frame: Preoperatively (after the consent process and before surgery) ]
  • Satisfaction with Decision Score using the Satisfaction with Decision Scale (SDS) [ Time Frame: Immediately after consent (Preoperative), Postoperative Day 22, and Postoperative Day 100 ]
  • Decision Regret Score using the Decision Regret Scale (DRS) [ Time Frame: Postoperative Day 22 and Postoperative Day 100 ]
  • Anxiety Score using the Visual Analog Scale for Anxiety (VAS-A) [ Time Frame: Immediately after consent (Preoperative), Postoperative Day 22, and Postoperative Day 100 ]

Central Contacts and Locations

Central contacts

Annie Moroco Assistant Professor, MD

215-955-6826Annie.Moroco@jefferson.edu

Hani Research Fellow, BS

3216091134hxs597@jefferson.edu

Locations

Thomas Jefferson University

Recruiting

Philadelphia, Pennsylvania, United States, 19107

Contacts

Elizabeth Cottrill Assistant Professor, MD

215-955-6760Elizabeth.Cottrill@jefferson.edu

More Information

Sponsor

Thomas Jefferson University

Last update posted

Apr 13, 2025

Last verified

Apr, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Thomas Jefferson University on 2025-04-13.