N/A
N=126
The Effect of Surgeon Emotional Support on Treatment Choice for Low-risk Thyroid Cancer
Thyroid Cancer · Thyroid Nodule · Benign Thyroid Nodule
Bottom Line
View on ClinicalTrials.gov: NCT05132478 ↗Enrolled (actual)
126
Serious AEs
0.0%
Results posted
Apr 2024
Primary outcome: Primary: Treatment Choice — 54; 51; 6; 7 Participants — p=0.720
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Emotionally Supportive Video (Other); Standard Video (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Wisconsin, Madison
- Primary completion
- Feb 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Treatment Choice |
54; 51; 6; 7 | 0.720 |
| SECONDARY Participant Decisional Confidence Score |
7.6; 7.7 | 0.743 |
| SECONDARY State Trait Anxiety Inventory Brief (STAI Brief) Score |
9.5; 8.8; 12.1; 11.1 | 0.228 |
| SECONDARY Adapted Thyroid Cancer Fear Scale Score |
26.0; 27.0; 24.2; 25.4 | 0.410 |
| SECONDARY Adapted Jefferson Scale of Patient's Perceptions of Physician's Empathy Score |
34.5; 25.9 | <0.001 sig |
| SECONDARY Adapted Trust in Physician Scale Score |
12.0; 10.4 | <0.001 sig |
Summary
118 adults with benign thyroid nodules who were seen at a UW Health clinic for a fine needle biopsy and do not need surgery will be enrolled and can expect to be on study for a one-time visit of up to 60 minutes. Each participant will be randomized to watch one of two videos simulating a patient-surgeon discussion about treatment options for low-risk thyroid cancer with or without emotionally supportive statements.
Eligibility Criteria
Inclusion Criteria (Determined during electronic medical record (EMR) screening):
- Seen in a UW Health Clinic for fine needle aspiration (FNA) of a thyroid nodule in the last 30 days
- Thyroid nodule measures ≤4 centimeters
- Benign thyroid nodule biopsy result
- Able to speak and read English
- Access to internet
Inclusion Criteria (Determined/reconfirmed during pre-study screening on Qualtrics):
- Seen in a UW Health Clinic for FNA of a thyroid nodule in the last 30 days
Exclusion Criteria (Determined during EMR screening):
- Additional thyroid nodule biopsy results that are not benign
- History of thyroid cancer
- History of thyroid surgery
- Has seen a surgeon about thyroid or parathyroid surgery
- Has a referral to see a surgeon about thyroid surgery
- Deaf
- Blind
- Vulnerable populations such as prisoners
Exclusion Criteria (Reconfirmed during pre-study screening on Qualtrics):
- History of thyroid cancer
- History of thyroid surgery
- Has seen a surgeon about thyroid or parathyroid surgery
- Plans to see a surgeon about thyroid surgery
Data sourced from ClinicalTrials.gov (NCT05132478). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.