Clinical trial NCT05132478: The Effect of Surgeon Emotional Support on Treatment Choice for Low-risk Thyroid Cancer
Official title: The Effect of Surgeon Emotional Support on Treatment Choice for Low-risk Thyroid Cancer: a Randomized Hypothetical Choice Experiment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Thyroid Cancer
Thyroid Nodule
Benign Thyroid Nodule
Keywords: thyroid cancer
low-risk
thyroidectomy
emotional support
treatment
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
name: University of Michigan
First posted: 2021-11-24
Enrollment: 126
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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.

Detailed description: In this study, the investigators will test the extent to which emotionally supportive communication from a surgeon is associated with patient preference for total thyroidectomy. The investigators will conduct a hypothetical choice experiment with "analogue" patients, defined as those with a benign thyroid nodule not requiring surgery.

Baseline measures will be collected, then participants will be randomized to watch a video simulation of a patient-surgeon discussion about treatment options for low-risk thyroid cancer with or without emotionally supportive statements.

The investigators hypothesize that increased emotionally supportive communication by the surgeon will decrease the likelihood of patients choosing total thyroidectomy, reduce anxiety and thyroid cancer fear, and increase decisional confidence, perceived physician empathy, trust in physician, and information recall.

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

Primary outcomes:
measure: Treatment Choice
timeFrame: post video intervention (up to 60 minutes during the only study visit)
Secondary outcomes:
measure: Participant Decisional Confidence Score
timeFrame: post video intervention (up to 60 minutes during the only study visit)
measure: State Trait Anxiety Inventory Brief (STAI Brief) Score
timeFrame: measured at baseline and after video intervention (during 1 day study visit)
measure: Adapted Thyroid Cancer Fear Scale Score
timeFrame: measured at baseline and after video intervention (during 1 day study visit)
measure: Adapted Jefferson Scale of Patient's Perceptions of Physician's Empathy Score
timeFrame: post video intervention (up to 60 minutes during the only study visit)
measure: Adapted Trust in Physician Scale Score
timeFrame: post video intervention (up to 60 minutes during the only study visit)
Other outcomes:
Locations:
city: Madison
country: United States
facility: University of Wisconsin Carbone Cancer Center
state: Wisconsin
Study officials:
affiliation: UW School of Medicine and Public Health
name: Corrine Voils, PhD
role: PRINCIPAL_INVESTIGATOR
References: