The Effect of Surgeon Emotional Support on Treatment Choice for Low-risk Thyroid Cancer

Study Overview
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Brief Summary
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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
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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.

Official Title
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The Effect of Surgeon Emotional Support on Treatment Choice for Low-risk Thyroid Cancer: a Randomized Hypothetical Choice Experiment

Conditions
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Thyroid Cancer, Thyroid Nodule, Benign Thyroid Nodule

Intervention / Treatment
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* Other: Emotionally Supportive Video
* Other: Standard Video


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard Video<br>A video simulation of a patient-surgeon discussion about treatment options for low-risk thyroid cancer WITHOUT emotionally supportive statements | Other: Standard Video<br>* The video is approximately 5 minutes in length and portrays a standard conversation between a patient and surgeon during which the surgeon discusses: the diagnosis, prognosis, available treatment options, benefits and harms of the options, and need for decision making. The surgeon speaks for the majority of the simulated visit and discusses total and hemi-thyroidectomy.<br>|
| Experimental: Emotionally Supportive Video<br>A video simulation of a patient-surgeon discussion about treatment options for low-risk thyroid cancer WITH emotionally supportive statements | Other: Emotionally Supportive Video<br>* The video is approximately 6 1/2 minutes in length and portrays an emotionally supportive conversation between a patient and surgeon during which the surgeon discusses: the diagnosis, prognosis, available treatment options, benefits and harms of the options, and need for decision making. The surgeon speaks for the majority of the simulated visit and discusses total and hemi-thyroidectomy with the addition of emotionally supportive statements and gestures.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment Choice | The investigators will measure which treatment participants would choose if they were the patient with thyroid cancer in the video (total thyroidectomy or hemithyroidectomy) immediately after they finish watching the video. | post video intervention (up to 60 minutes during the only study visit) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Participant Decisional Confidence Score | Decisional Confidence in treatment option is measured using a single-item 10-point Likert scale where 1 is 'not confident at all' and 10 is 'completely confident' | post video intervention (up to 60 minutes during the only study visit) | 
| State Trait Anxiety Inventory brief (STAI brief) Score | The STAI brief is a 6-item survey about how the participant is feeling in the moment (calm, tense, upset, relaxed, content, worried) scored on a 4 point likert scale. The total possible range of scores is 6 to 24 with higher scores indicating higher anxiety. | measured at baseline and after video intervention (during 1 day study visit) | 
| Adapted Thyroid Cancer Fear Scale Score | The adapted Thyroid Cancer Fear Scale is a 8-item survey originally designed to assess fear of breast cancer in patients undergoing cancer screening. Items are rated on a 5-point scale from strongly disagree (1) to strongly agree (5) with a total possible range of scores from 8-40 where higher scores indicate increased fear of cancer. | measured at baseline and after video intervention (during 1 day study visit) | 
| Adapted Jefferson Scale of Patient's Perceptions of Physician's Empathy Score | This 5-question instrument assesses patient perceptions of physician empathy, scored on a 7-point Likert scale ranging from 'strongly disagree' (1) to 'strongly agree' (7). Items are summed, with a max score of 35, higher values indicate a perception of more empathy. | post video intervention (up to 60 minutes during the only study visit) | 
| Adapted Trust in Physician Scale Score | This 5-question instrument assesses patient trust in a physician, scored on a 5-point Likert scale ranging from 'strongly disagree' (1) to 'strongly agree' (5). Responses are summed and scores are on a scale of 5 to 25, with higher values indicating more trust. | post video intervention (up to 60 minutes during the only study visit) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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thyroid cancer, low-risk, thyroidectomy, emotional support, treatment