The Effect of Surgeon Emotional Support on Treatment Choice for Low-risk Thyroid Cancer: a Randomized Hypothetical Choice Experiment
Phase: NA
Conditions: Thyroid Cancer, Thyroid Nodule, Benign Thyroid Nodule
Sponsor: University of Wisconsin, Madison

CONFIDENTIALITY STATEMENT 
 
This document is confidential communication. Acceptance of this document constitutes agreement by the recipient that no 
unpublished information contained herein will be published or disclosed without prior approval of the Principal 
Investigator or other participating study leadership and as consistent with the NIH terms of award. 
 
 
The effect of surgeon emotional support on treatment choice for low-risk thyroid cancer:  
a randomized hypothetical choice experiment 
 
 
 
Protocol Number: UW21090 
 
National Clinical Trial (NCT) Identified Number: NCT05132478 
 
Principal Investigator*: Corrine Voils, PhD 
 
Sponsor: National Cancer Institute 
 
Grant Title: Impact of Emotions on Treatment Decisions About Low-Risk Thyroid Cancer 
 
Grant Number: K08CA230204 
 
Funded by: National Cancer Institute 
 
Version Number: v.2 
 
8 November 2021 
 
 

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Contents 
STATEMENT OF COMPLIANCE ................................................................................................................ 4 
INVESTIGATOR’S SIGNATURE ................................................................................................................ 5 
1 
PROTOCOL SUMMARY ........................................................................................................................ 5 
1.1 SYNOPSIS .............................................................................................................................................. 5 
1.3 SCHEMA .................................................................................................................................................. 8 
1.3 SCHEDULE OF ACTIVITIES ............................................................................................................ 9 
2 
INTRODUCTION ..................................................................................................................................... 10 
2.1 STUDY RATIONALE ......................................................................................................................... 10 
2.2  BACKGROUND ................................................................................................................................... 10 
2.3 RISK/BENEFIT ASSESSMENT ..................................................................................................... 11 
2.3.1 KNOWN POTENTIAL RISKS ............................................................................................... 11 
2.3.2 KNOWN POTENTIAL BENEFITS ....................................................................................... 11 
2.3.3 ASSESSMENT OF POTENTIAL RISKS AND BENEFITS ......................................... 11 
3 
OBJECTIVES AND ENDPOINTS ..................................................................................................... 12 
4  
STUDY DESIGN...................................................................................................................................... 12 
4.1 OVERALL DESIGN ............................................................................................................................ 13 
4.2 SCIENTIFIC RATIONALE FOR STUDY DESIGN ................................................................... 14 
4.3 JUSTIFICATION FOR INTERVENTION ..................................................................................... 14 
4.4 END-OF-STUDY DEFINITION ....................................................................................................... 14 
5 
STUDY POPULATION .......................................................................................................................... 14 
5.1 INCLUSION CRITERIA .................................................................................................................... 14 
5.2 EXCLUSION CRITERIA ................................................................................................................... 15 
5.3 LIFESTYLE CONSIDERATIONS .................................................................................................. 15 
5.4 SCREEN FAILURES ......................................................................................................................... 15 
5.5 STRATEGIES FOR RECRUITMENT AND RETENTION ...................................................... 15 
6 
STUDY INTERVENTION(S) OR EXPERIMENTAL MANIPULATION(S) ........................... 16 
6.1 STUDY INTERVENTION(S) OR EXPERIMENTAL MANIPULATION(S) 
ADMINISTRATION ..................................................................................................................................... 16 
6.1.1 STUDY INTERVENTION OR EXPERIMENTAL MANIPULATION DESCRIPTION
 
16 
6.1.2 ADMINISTRATION AND/OR DOSING .............................................................................. 16 
6.2 FIDELITY ............................................................................................................................................... 16 
6.2.1 INTERVENTIONIST TRAINING AND TRACKING ........................................................ 16 

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6.3 MEASURES TO MINIMIZE BIAS: RANDOMIZATION AND BLINDING.......................... 16 
6.4 STUDY INTERVENTION/EXPERIMENTAL MANIPULATION ADHERENCE ............... 17 
6.5 CONCOMITANT THERAPY ............................................................................................................ 17 
6.5.1 RESCUE THERAPY ................................................................................................................ 17 
7 
STUDY INTERVENTION/EXPERIMENTAL MANIPULATION DISCONTINUATION 
AND PARTICIPANT DISCONTINUATION/WITHDRAWAL ............................................................ 17 
7.1 DISCONTINUATION OF STUDY INTERVENTION/EXPERIMENTAL 
MANIPULATION.......................................................................................................................................... 17 
7.2 LOST TO FOLLOW-UP .................................................................................................................... 17 
7.3 PARTICIPANT DISCONTINUATION/WITHDRAWAL FROM THE STUDY ................... 17 
8 
STUDY ASSESSMENTS AND PROCEDURES .......................................................................... 17 
8.1 ENDPOINT AND OTHER NON-SAFETY ASSESSMENTS ................................................. 17 
8.2 SAFETY ASSESSMENTS ............................................................................................................... 19 
8.3 ADVERSE EVENTS AND SERIOUS ADVERSE EVENTS .................................................. 19 
8.3.1 DEFINITION OF ADVERSE EVENTS ............................................................................... 19 
8.3.2 DEFINITION OF SERIOUS ADVERSE EVENTS .......................................................... 19 
8.3.3 CLASSIFICATION OF AN ADVERSE EVENT ............................................................... 19 
8.3.4 TIME PERIOD AND FREQUENCY FOR EVENT ASSESSMENT AND FOLLOW-
UP 
19 
8.3.5 ADVERSE EVENT REPORTING ........................................................................................ 19 
8.3.6 SERIOUS ADVERSE EVENT REPORTING ................................................................... 20 
8.3.7 REPORTING EVENTS TO PARTICIPANTS ................................................................... 20 
8.3.8 EVENTS OF SPECIAL INTEREST .................................................................................... 20 
8.3.9 REPORTING OF PREGNANCY .......................................................................................... 20 
8.4 UNANTICIPATED PROBLEMS ..................................................................................................... 20 
8.4.1 DEFINITION OF UNANTICIPATED PROBLEMS.......................................................... 20 
8.4.2  UNANTICIPATED PROBLEMS REPORTING ............................................................... 20 
8.4.3 REPORTING UNANTICIPATED PROBLEMS TO PARTICIPANTS ....................... 20 
9 
STATISTICAL CONSIDERATIONS ................................................................................................. 21 
9.1 STATISTICAL HYPOTHESES ....................................................................................................... 21 
9.2 SAMPLE SIZE DETERMINATION ................................................................................................ 21 
9.3 POPULATIONS FOR ANALYSES ................................................................................................ 21 
9.4 STATISTICAL ANALYSES .............................................................................................................. 21 
9.4.1 GENERAL APPROACH .......................................................................................................... 21 
9.4.2 ANALYSIS OF THE PRIMARY ENDPOINT(S) .............................................................. 21 

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9.4.3 ANALYSIS OF THE SECONDARY ENDPOINT(S) ...................................................... 22 
9.4.4 SAFETY ANALYSES ............................................................................................................... 22 
9.4.5 BASELINE DESCRIPTIVE STATISTICS ......................................................................... 22 
9.4.6 PLANNED INTERIM ANALYSES ........................................................................................ 22 
9.4.7 SUB-GROUP ANALYSES ...................................................................................................... 22 
9.4.8 TABULATION OF INDIVIDUAL PARTICIPANT DATA ................................................ 22 
9.4.9 EXPLORATORY ANALYSES ............................................................................................... 23 
10 SUPPORTING DOCUMENTATION AND OPERATIONAL CONSIDERATIONS .............. 23 
10.1  REGULATORY, ETHICAL, AND STUDY OVERSIGHT CONSIDERATIONS ........... 23 
10.1.1 INFORMED CONSENT PROCESS .................................................................................... 23 
10.1.2  STUDY DISCONTINUATION AND CLOSURE ............................................................. 23 
10.1.3 CONFIDENTIALITY AND PRIVACY .................................................................................. 24 
10.1.4  FUTURE USE OF STORED SPECIMENS AND DATA ............................................. 25 
10.1.5 KEY ROLES AND STUDY GOVERNANCE ..................................................................... 25 
10.1.6 SAFETY OVERSIGHT ............................................................................................................ 25 
10.1.7 CLINICAL MONITORING ....................................................................................................... 26 
10.1.8 QUALITY ASSURANCE AND QUALITY CONTROL .................................................... 26 
10.1.9 DATA HANDLING AND RECORD KEEPING ................................................................. 26 
10.1.10 PROTOCOL DEVIATIONS.................................................................................................. 27 
10.1.11 PUBLICATION AND DATA SHARING POLICY .......................................................... 27 
10.1.12 CONFLICT OF INTEREST POLICY ................................................................................ 28 
10.2 ADDITIONAL CONSIDERATIONS ............................................................................................. 28 
10.3 ABBREVIATIONS AND SPECIAL TERMS .............................................................................. 28 
10.4 PROTOCOL AMENDMENT HISTORY ...................................................................................... 30 
11 REFERENCES .......................................................................................................................................... 31 
 
STATEMENT OF COMPLIANCE 
 
The trial will be carried out in accordance with International Council on Harmonisation Good Clinical Practice 
(ICH GCP) and the following:  
 
United States (US) Code of Federal Regulations (CFR) applicable to clinical studies (45 CFR Part 46, 21 CFR 
Part 50, 21 CFR Part 56, 21 CFR Part 312, and/or 21 CFR Part 812).  
 

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National Institutes of Health (NIH)-funded investigators and clinical trial site staff who are responsible for the 
conduct, management, or oversight of NIH-funded clinical trials have completed Human Subjects Protection 
and ICH GCP Training. 
 
The protocol, informed consent form(s), recruitment materials, and all participant materials will be submitted to 
the IRB for review and approval. Approval of both the protocol and the consent form(s) must be obtained 
before any participant is consented. Any amendment to the protocol will require review and approval by the 
IRB before the changes are implemented to the study. All changes to the consent form(s) will be IRB 
approved; a determination will be made regarding whether a new consent needs to be obtained from 
participants who provided consent, using a previously approved consent form. 
INVESTIGATOR’S SIGNATURE 
 
The signature below constitutes the approval of this protocol and provides the necessary assurances that this 
study will be conducted according to all stipulations of the protocol, including all statements regarding 
confidentiality, and according to local legal and regulatory requirements and applicable US federal regulations 
and ICH guidelines. 
 
Principal Investigator or Clinical Site Investigator: 
 
Name* Corrine I. Voils, PhD 
Title*: Professor 
Affiliation*: University of Wisconsin Department of Surgery 
Address:  600 Highland Ave, K6/100 CSC, Madison, WI 53792-1690 
Telephone: 608-262-9636 
Email: voils@surgery.wisc.edu 
 
Signed:_________________________________________   Date: __________ 
 
1 
PROTOCOL SUMMARY 
1.1 SYNOPSIS  
Title: 
The effect of surgeon emotional support on treatment choice for 
low-risk thyroid cancer: a randomized hypothetical choice 
experiment 
Grant Number: 
K08CA230204 

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Study Description: 
In this study, we will test the extent to which emotionally supportive 
communication from a surgeon is associated with patient 
preference for total thyroidectomy. We will conduct a hypothetical 
choice experiment with “analogue” patients, defined as those with a 
benign thyroid nodule not requiring surgery. We will collect baseline 
measures, then randomize participants to watch a video simulation 
of a patient-surgeon discussion about treatment options for low-risk 
thyroid cancer with or without emotionally supportive statements. 
We 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.  
 
Objectives*: 
 
Primary Objective: Test the extent to which emotionally supportive 
communication by a surgeon is associated with patient preference 
for total thyroidectomy. 
Secondary Objectives: Test the extent to which emotionally 
supportive communication by surgeons is associated with anxiety, 
thyroid cancer fear, perceived empathy, physician trust, and 
decisional confidence. 
Tertiary/Exploratory Objectives: Test the extent to which 
emotionally supportive communication by a surgeon is associated 
with information recall. 
Endpoints*: 
Primary Endpoint: Hypothetical treatment choice immediately after 
watching the video intervention 
Secondary Endpoints: state anxiety, thyroid cancer fear, decisional 
confidence, perceived physician empathy, physician trust 
immediately after watching the video intervention 
Tertiary Endpoint: information recall immediately after watching the 
video intervention 
Study Population: 
118 adults with benign thyroid nodules who were seen at a UW 
Health clinic for a fine needle biopsy and do not need surgery 
Phase* or Stage: 
N/A  
Description of 
Sites/Facilities Enrolling 
Participants: 
 
Single-site study at University of Wisconsin-Madison, including 
biopsy clinics at UW Health at the American Center, 1 South Park, 
and UW Hospital & Clinics   
Description of Study 
Intervention/Experimental 
Manipulation: 
Participants will be randomized to watch one of two 6-minute videos 
depicting a surgeon-patient discussion about treatment options for 
low-risk thyroid cancer. The dialogue in the videos is the same 
except one contains emotionally supportive language.  
Study Duration*: 
36 months 

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Participant Duration: 
Participants will be recruited for the study within 21 days of their 
thyroid nodule biopsy. Their one-time study session will occur within 
30 days of their biopsy and will last up to 60 minutes. 
 
 

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1.3 SCHEMA  
 
 
Pre-Screening and 
Recruitment 
<within 21 days 
of biopsy> 
 
 
 
 
 
Study visit 
<within 30 days 
of biopsy> 
 
 
 
 
 
 
 
 
 
 
 
 
Total N: 600 
Pre-screen potential participants by inclusion and exclusion criteria. 
Confirm eligibility. Conduct consent process. Perform baseline assessments. 
 
Section 1.3, Schedule of Activities 
Outcome measurements 
 
See Section 1.3, Schedule 
of Activities 
Arm 1 
(Standard video) 
N = 59 
Administer study intervention 
Randomize 
Arm 2 
(Emotionally supportive video) 
N = 59 
Inform and recruit potentially eligible participants. 

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1.3 SCHEDULE OF ACTIVITIES  
 
 
 
 
 
Screening & 
recruitment 
(within 21 days of biopsy) 
Study participation 
(single study session will 
be completed within 30 
days of biopsy) 
EMR Review Eligibility 
X 
 
Participant recruitment  
X 
 
Eligibility confirmation 
 
X 
Consent 
 
X 
Demographics 
 
X 
Clinical history 
 
X 
Thyroid cancer fear 
 
X 
State Anxiety 
 
X 
Stratified Randomization 
 
X 
Video intervention 
 
X 
Outcome Evaluation 
 
 
Treatment choice 
 
X 
State anxiety 
 
X 
Thyroid cancer fear 
 
X 
Decisional confidence 
 
X 
Perceived physician empathy  
 
X 
Physician trust 
 
X 
Information recall 
 
X 
Adverse Events Reporting 
 
X 

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2 
INTRODUCTION 
2.1 STUDY RATIONALE  
Thyroid cancer incidence has increased significantly due to incidental detection of small, low-risk cancers.1–10  
The majority of these patients undergo total thyroidectomy, even though hemi-thyroidectomy has comparable 
long-term outcomes.11–13  Compared to hemi-thyroidectomy, total thyroidectomy has greater potential for 
serious long-term, permanent adverse harms.3,10,14–20  Because both treatment options have equivalent 
recurrence and survival, total thyroidectomy is considered overtreatment, as the potential harms outweigh the 
oncologic benefit.5,12,21–23,24 
Data suggest that despite near 100% survival, patients with low-risk thyroid cancer experience fear and anxiety 
in response to their diagnosis and a desire to “get the cancer out” to achieve peace of mind.25–29 This reaction 
combined with lack of emotional support likely contribute greatly to preference for total thyroidectomy. To 
reduce overtreatment of these low-risk cancers, this study seeks to understand the effect of emotionally 
supportive language from surgeons on patients’ treatment decisions.  
This study involves a hypothetical choice experiment with “analogue” patients, defined as those with a benign, 
≤4 cm thyroid nodule not requiring surgery. After obtaining baseline measures of demographics, thyroid 
history, state anxiety, and cancer fear, we will randomize participants to watch a video simulation of a patient-
surgeon discussion about treatment options for low-risk thyroid cancer with or without emotionally supportive 
statements. Afterward, participants will complete post-test measures regarding which treatment they would 
choose if they were the patient in the video, state anxiety, cancer fear, decisional confidence, reactions to the 
video including perception of physician empathy and level of trust, and information recall. We will compare 
outcomes by study arm. We 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.  
2.2  BACKGROUND  
In the last four decades, thyroid cancer diagnoses have increased significantly, primarily due to low-risk 
cancers with a very low mortality.1–3,12 Most patients with these low-risk thyroid cancers undergo total 
thyroidectomy, a riskier surgical approach that represents overtreatment for many because it does not improve 
survival compared to less extensive options.12,14,21,23 Overtreatment with total thyroidectomy can result in harms 
such as difficulty speaking, swallowing, regulating calcium, and significant fatigue.17–20,30–36  Patients must also 
take life-long thyroid hormone replacement, which is associated with adverse cognitive and bone-related 
outcomes.17,19,20,30   
 
Preference for total thyroidectomy is difficult to explain with models of rational decision-making. Rational models 
of decision-making would predict that patients would prefer hemi-thyroidectomy which has equivalent oncologic 
outcomes, but reduced risk of harms compared to total thyroidectomy. However, most patients with low-risk 
thyroid cancer undergo total thyroidectomy. Therefore, alternative explanations are needed to explain why 
patients prefer the riskier treatment option. 
 

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Our preliminary findings indicate that patients with low-risk thyroid cancer experience strong negative 
emotions, such as fear and anxiety, that may affect their treatment preference. Emotions are known to play a 
role in treatment and screening decisions in patients with other malignancies, such as breast or prostate 
cancer, leading to unwanted, unnecessary, or overly extensive care.25,26,37–40 Therefore, the hypothesis of this 
line of investigation is that emotions influence patients’ treatment decisions about low-risk thyroid cancer, 
leading to decisions that over treat. 
 
Previous studies using patient-physician simulation have demonstrated that emotionally supportive statements 
from a physician can reduce patient anxiety, increase patient trust, and increase information recall.41–45  The 
results have been successfully translated back into clinical practice for the development of effective physician-
based interventions.42–44,46  
 
For this study, we hypothesize that increased emotionally supportive communication by the surgeon will 
decrease the likelihood of patients choosing total thyroidectomy, reduce anxiety, decrease thyroid cancer fear, 
and increase decisional confidence, perceived empathy, trust in the surgeon, and recall. The results will 
provide new evidence about how emotions influence cancer-related decisions and help elucidate the effect of 
responding to emotional reactions to thyroid cancer diagnosis on treatment choice.  
2.3 RISK/BENEFIT ASSESSMENT   
2.3.1 KNOWN POTENTIAL RISKS  
This study meets the criteria for minimal risk, as the probability and magnitude of harm or discomfort 
anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life. 
There are known potential risks for participants: in addition to potential loss of confidentiality, there is potential 
for psychological stress from taking a survey that asks them to imagine they have been diagnosed with cancer. 
Similar studies have been performed in patients without a cancer diagnosis with no known adverse outcomes. 
2.3.2 KNOWN POTENTIAL BENEFITS  
Participants are not expected to benefit directly from participating in this study. Participation in this research 
study may benefit other patients and surgeons in the future by helping us learn more about how emotionally 
supportive communication by surgeons might affect treatment decisions for low-risk thyroid cancer. This will 
eventually help our research team to develop, test, and implement interventions that reduce healthcare costs 
and decrease unnecessary harms, improving quality of life for patients with thyroid cancer by helping them avoid 
riskier surgery. We also anticipate that our findings will translate to other malignancies and inform the 
development of tools that improve our ability to reduce overtreatment of patients with other cancers. 
2.3.3 ASSESSMENT OF POTENTIAL RISKS AND BENEFITS  
This study presents minimal risks to participants, as the probability and magnitude of harm or discomfort 
anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life. 
The risks of this study are outweighed by the benefits as the study poses minimal risk to participants. In the 
future, a better understanding of factors that impact cancer fear may benefit patients. As such, participants 
benefit by knowing that they are helping future cancer patients. 

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Participants will be informed that participation is voluntary and they may skip questions they do not want to 
answer and/or decline to compete the study. They will be reminded to contact their provider if they experience 
emotional distress. 
 
Multiple steps have been incorporated to reduce the likelihood of a breach in confidentiality. Furthermore, if a 
breach in confidentiality occurs, it will not negatively impact these participants because the data collected are 
not sensitive or stigmatizing in any way. 
 
Study investigators and staff will be alert for any potential harms to participants, including breaches of 
confidentiality. Any breach of confidentiality will be immediately reported to the principal investigator and the 
UW-Madison Minimal Risk IRB, and the UW-Madison HIPAA Privacy and Security Officers. The risk of breach 
of confidentiality is low because adequate provisions are in place to ensure that breach of confidentiality will 
not occur, as described in section 10.1.3. 
3 
OBJECTIVES AND ENDPOINTS  
 
OBJECTIVES 
ENDPOINTS 
JUSTIFICATION FOR ENDPOINTS 
Primary 
Test the extent to which increased 
emotionally supportive communication by 
surgeons is associated with patient 
preference for total thyroidectomy. 
 
We 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. 
Treatment choice is the primary endpoint 
because prior studies in different 
populations indicate increased emotional 
support can influence medical choices. 
Emotionally supportive communication is 
most likely to impact patient preference 
in the short-term, as the treatment 
decision is being made.  
Secondary 
Test the extent to which increased 
emotionally supportive communication by 
surgeons is associated with anxiety, thyroid 
cancer fear, perceived empathy, trust, and 
decisional confidence. 
 
We will measure these endpoints 
immediately after participants finish 
watching the video, using the State 
Trait Anxiety Inventory brief, an 
adapted Cancer Fear Scale an adapted 
Trust in Physician Scale, an adapted 
Jefferson Scale of Patient’s Perceptions 
of Physician’s Empathy, and decisional 
confidence using a single-item 10-point 
Likert scale.  
These secondary endpoints were 
selected because they represent 
potential emotion-related outcomes in 
the treatment decision-making process. 
Prior studies indicate the increased 
emotionally supportive communication 
can influence these outcomes in other 
medical settings. 
Tertiary/Exploratory  
Test the extent to which increased 
emotionally supportive communication by 
surgeons is associated with information 
recall. 
We will assess information recall 
immediately after participants finish 
watching the video with 5 multiple 
choice questions that ask about 
information relayed in both 
intervention videos. 
Published data suggest that heightened 
emotional states can inhibit information 
processing and recall. Response to this 
heightened state with increased 
emotional support may improve recall. 
 
4  STUDY DESIGN 

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4.1 OVERALL DESIGN 
 
In this single-site, two-arm, between-subjects hypothetical choice experiment, we will test the extent to which 
increased emotionally supportive communication by surgeons is associated with patient preference for total 
thyroidectomy. We will use “analogue” patients, defined as those with a benign thyroid nodule, ≤4 cm not 
requiring surgery. We will randomize these patients to watch a video simulation of a patient-surgeon discussion 
about treatment options for low-risk thyroid cancer with or without emotionally supportive statements. We 
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, trust in physician, perceived physician empathy, and information recall. This study will provide new 
evidence about how emotions influence cancer-related decisions. This knowledge is necessary for the design 
of effective interventions that attend to both emotions and cognition in decision-making. We expect this 
comprehensive strategy to reduce overtreatment and morbidity in patients with small, low-risk thyroid and other 
low-risk cancers.  
 
Potentially eligible patients will arrive to clinic, undergo needle biopsy of their thyroid nodule, and receive a 
study brochure. Cytology results are automatically released to patients via MyChart and the ordering physician 
calls the patient within 24-48 hours with their results. Once a benign diagnosis and eligibility is confirmed via 
chart review, we will approach patients and enroll interested participants within 30 days of their diagnosis. 
Patients will complete the study in one sitting on a computer or tablet in their own home by accessing a 
Qualtrics link at a time that is convenient for them. They will confirm their eligibility through screening questions 
and then proceed to the information page with consent language. If they have questions about the information 
page, they are directed to contact the study team before indicating consent. Once they indicate consent they 
will proceed to the pre-intervention survey (administered prior to randomization) which will include 
demographics (sex assigned at birth, age, race, ethnicity, education, personal cancer history, clinical history 
regarding their recent biopsy, and baseline measures including the STAI-6 and thyroid cancer fear scale. 47,48 
Participants will then get randomized by Qualtrics to a study arm. After viewing the video, they will complete 
measures including the STAI-6, an adapted cancer fear scale, manipulation check, physician empathy scale, 
trust in physician scale, a 5-question information recall questionnaire about the treatment options discussed in 
the video, and the following questions: (1) “If you were the patient in the video, which treatment option would 
you choose for yourself?” and (2) “How confident do you feel that you would be choosing the best treatment 
option for you?” on a 10-point scale [not at all confident to completely confident].47–50 Our primary outcome is 
treatment choice: total or hemi-thyroidectomy. We chose the STAI-6 because of its predictive validity in 
assessing changes induced by hypothetical choice experiments in patients with cancer.41,45  Our post-
intervention measures are further described in Section 8.1. Participation is expected to take less than 30 
minutes to complete. 
 
Intervention: We have created two videos using rigorous methods described by van Vleit et al. for creating 
internally and externally valid videos that manipulate affective communication. 51 The videos are 5-6 minutes in 
length and portray a 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. 
The scripts are identical between arms except for the addition of emotionally supportive statements and 

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gestures in the intervention script. This study design using simulated patient-provider conversations that 
manipulate affective communication in analogue patients has been employed by others and successfully 
translated back into clinical practice for the development of effective physician-based interventions.42–44,46  
 
Randomization: Participants will be stratified based on sex. Males are more likely to undergo less extensive 
treatment.12 After completion of consent and the pre-intervention survey that includes demographics, Qualtrics 
will direct participants into two separate survey branches: males and females. Qualtrics will randomize 
participants 1:1 to a video within each branch. They will then proceed to the post-intervention measures. Study 
staff will not know participants’ arm assignment. 
4.2 SCIENTIFIC RATIONALE FOR STUDY DESIGN 
Use of analogue patients (i.e. patients with benign thyroid nodules that do not need surgery) is necessary 
because this type of controlled experiment is not feasible in clinical practice and may affect patients’ treatment 
course. 
4.3 JUSTIFICATION FOR INTERVENTION 
The 5-6 minute video intervention will be delivered while patients are completing the study on a computer or 
tablet in their own home. We have chosen this mode of delivery because it is not feasible to deliver the 
intervention on the same day as the thyroid nodule biopsy. Final cytology results are not available on the same 
day; we do not want to over burden patients on the day of their appointment; and we want to allow a short 
washout period from time of biopsy to time of study participation. 
4.4 END-OF-STUDY DEFINITION 
 
A participant is considered to have completed the study if they have completed the baseline assessment, the 
intervention, and the follow-up assessments.  
5 
STUDY POPULATION 
5.1 INCLUSION CRITERIA 
In order to be eligible to participate in this study, an individual must meet all of the following criteria: 
Determined during EMR screening 
1. Aged 18 or older 
2. Seen in a UW Health Clinic for FNA (fine needle aspiration) of a thyroid nodule in the last 30 days 
3. Thyroid nodule measures ≤4 centimeters 
4. Benign thyroid nodule biopsy result 
5. Able to speak and read English  
6. Access to internet 
 
Determined/reconfirmed during pre-study screening on Qualtrics 
1. Seen in a UW Health Clinic for FNA (fine needle aspiration) of a thyroid nodule in the last 30 days 

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5.2 EXCLUSION CRITERIA 
An individual who meets any of the following criteria will be excluded from participation in this study: 
Determined during EMR screening 
1. Additional thyroid nodule biopsy results that are not benign 
2. History of thyroid cancer 
3. History of thyroid surgery 
4. Has seen a surgeon about thyroid or parathyroid surgery 
5. Has a referral to see a surgeon about thyroid surgery 
6. Deaf 
7. Blind 
8. Vulnerable populations such as prisoners 
 
Reconfirmed during pre-study screening on Qualtrics 
1. History of thyroid cancer 
2. History of thyroid surgery 
3. Has seen a surgeon about thyroid or parathyroid surgery 
4. Plans to see a surgeon about thyroid surgery 
5.3 LIFESTYLE CONSIDERATIONS 
N/A 
5.4 SCREEN FAILURES 
N/A 
5.5 STRATEGIES FOR RECRUITMENT AND RETENTION 
We will enroll 118 patients 18 years of age and older who are seen in a UW Health Clinic for a fine needle 
aspiration (FNA) of a thyroid nodule and receive benign pathology results. About 70% of FNAs at UW are 
benign, however not all patients with benign FNAs will meet other inclusion criteria. We anticipate screening 
approximately 600 patients in order to reach 118 participants. 
 
Study staff will mail letters endorsed by the physicians in UW biopsy clinics at UW Hospital, The American 
Center, and/or 1 South Park to all patients with upcoming thyroid nodule biopsy appointments. The letters will 
inform patients that they may be eligible for a study and the study team will contact them if they are eligible, 
unless they opt out of study communications. Once potentially eligible patients are at their biopsy appointment, 
they will hear about the study again as endocrinologists, radiologists, ultrasound technologists, or clinic staff 
such as medical assistants will give all patients who are getting thyroid nodule biopsies a study brochure. They 
will again tell the patient a study team member will contact them if they are eligible for the study, unless they 
opt out of study communications by contacting the study team. Study posters may also be posted in biopsy 
clinic rooms to remind clinic staff of eligibility criteria and tell patients about the study. 
 

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Study staff with UW Health electronic health record (Health Link) access may search clinic schedules, 
Launchpad pathology records, and/or patient list templates (e.g. reporting workbench reports, reports of 
targeted EHR searches set up by Clinical and Health Informatics Institute [CHI2]) made available to them as 
part of their research access to Health Link to mail letters, check biopsy results, and help identify participants 
for study enrollment. After a patient has a biopsy and receives a brochure, a member of the study team will 
verify eligibility criteria in Health Link and log eligibility results in a tracking document. If the patient is eligible, a 
member of the study team will contact the patient via phone, mail, and MyChart (if available, through CHI2) to 
recruit them for the study. If we are unable to reach the patient during our first phone and mail contact attempt, 
we may make up to three more contact attempts if necessary. All attempts to contact patients will be logged in 
a tracking document.  
 
We have designed study procedures including consent, baseline measures, intervention, and outcome 
measures to all take place in less than 30 minutes on one day, therefore we anticipate attrition will be low. We 
will be available by phone or email to answer questions that may arise during participation. 
 
Participant Incentive: 
All participants will receive a $40 check, cash, or gift card for completing the study. 
6 
STUDY INTERVENTION(S) OR EXPERIMENTAL MANIPULATION(S) 
6.1 
STUDY INTERVENTION(S) OR EXPERIMENTAL MANIPULATION(S) ADMINISTRATION 
6.1.1 STUDY INTERVENTION OR EXPERIMENTAL MANIPULATION DESCRIPTION 
We have created two videos using rigorous methods described by van Vleit et al. for creating internally and 
externally valid videos that manipulate affective communication.51  The videos are 5-6 minutes in length and 
portray a 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. The scripts 
are identical between arms except for the addition of emotionally supportive statements and gestures in the 
intervention script. This study design using simulated patient-provider conversations that manipulate affective 
communication in analogue patients has been employed by others and successfully translated back into 
clinical practice for the development of effective physician-based interventions.42–44,46 
6.1.2 ADMINISTRATION AND/OR DOSING 
The study intervention, i.e. video viewing, will last 5-6 minutes and will be administered once via Qualtrics online. 
6.2 FIDELITY 
6.2.1 INTERVENTIONIST TRAINING AND TRACKING 
N/A 
6.3 MEASURES TO MINIMIZE BIAS: RANDOMIZATION AND BLINDING 

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After completion of consent and the pre-intervention survey that includes demographics, Qualtrics will direct 
participants into two separate survey branches: males and females. Qualtrics will randomize participants 1:1 to 
a video within each branch. They will then proceed to the post-intervention measures. Study staff will not know 
participants’ arm assignment.  
6.4 STUDY INTERVENTION/EXPERIMENTAL MANIPULATION ADHERENCE 
In order to create common conditions for participants to the extent possible, participants will be instructed to 
complete the study in one sitting, on a tablet or computer, in a quiet place where they can concentrate. After the 
intervention, they will be asked to rate how fully they were able to concentrate on the video while it played. 
6.5 CONCOMITANT THERAPY 
N/A 
6.5.1 RESCUE THERAPY 
N/A 
 
7 
STUDY INTERVENTION/EXPERIMENTAL MANIPULATION DISCONTINUATION AND 
PARTICIPANT DISCONTINUATION/WITHDRAWAL 
7.1 DISCONTINUATION OF STUDY INTERVENTION/EXPERIMENTAL MANIPULATION 
N/A 
7.2 LOST TO FOLLOW-UP 
A randomized participant will be considered lost to follow-up if they fail to complete outcome measures. 
Participants who provide consent, are randomized, receive the study intervention, and subsequently withdraw 
will be considered randomized and will be analyzed in the arm assigned, consistent with intent-to-treat 
principles. Participants who provide consent but are not randomized and do not receive the study intervention 
will be replaced.    
 7.3 PARTICIPANT DISCONTINUATION/WITHDRAWAL FROM THE STUDY 
A participant will be considered lost to follow-up if they fail to complete the study after providing consent and 
study staff are unable to contact the participant after at least 3 attempts. Participants may withdraw from 
participation in the study at any time. 
8 
STUDY ASSESSMENTS AND PROCEDURES 
8.1 ENDPOINT AND OTHER NON-SAFETY ASSESSMENTS 
Screening and eligibility assessments: Study staff with UW Health electronic health record (Health Link) 
access will identify biopsy patients and verify eligibility criteria in Health Link within 21 days of biopsy. If the 
patient appears to be eligible, a member of the study team will contact the patient via phone and mail (and 

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MyChart, if available through CHI2) to recruit them for the study. Patients will be provided a link to the study on 
Qualtrics, where they can answer questions to verify their eligibility criteria and proceed to participation if 
eligible. Eligibility criteria verified at each screening stage is described in sections 5.1 and 5.2. Reasons for 
screening patients out will be documented at each step of the process. Age and sex of eligible patients will be 
retained for all eligible patients, including those who decline to participate, to assess any bias between 
respondents and non-respondents. 
 
Study data: Data will be collected virtually. Mode of data collection will not have adverse effects on our ability 
to test our study hypotheses. All study measurements will be entered by the participant into Qualtrics. 
 
Baseline demographic and clinical characteristics: We will collect age, sex assigned at birth, clinical history 
of their thyroid, ethnicity, race, highest educational level attained, anxiety, and level of thyroid cancer fear. 
 
Primary and secondary outcomes: 
Type  
Name 
Timing of 
Measure 
Brief description 
Primary 
Treatment choice 
Post-
intervention 
We will assess patients’ hypothetical treatment choice after the intervention. 
We will ask: “If you were the patient in the video and had recently been 
diagnosed with thyroid cancer, which of the two treatment options would 
you choose, knowing what you know right now?” Answers will include: 
removal of the entire thyroid, removal of half of the thyroid. 
Secondary 
Decision 
confidence 
Post-
intervention 
We will assess patients’ confidence in their treatment choice after the 
intervention. We will ask: “How confident do you feel that you are choosing 
the best treatment option for you?” Answers will range from 1 (not at all 
confident) to 10 (completely confident). 
N/A 
Manipulation 
check 
Post-
intervention 
We will assess patients’ engagement with the video with 5 items. Questions 
will ask about concentration and the extent to which the patient could 
identify with various aspects of the video. Response options are on a 7-point 
Likert scale ranging from ‘completely disagree’ [1] to ‘completely agree’ [7]. 
Secondary 
Anxiety – STAI 
Brief 
Baseline and 
Post-
intervention 
This 6-question, quantitative instrument was designed to assess state anxiety. 
47 Response options are on a 4-point Likert scale ranging from ‘not at all’ [1] 
to ‘very much’ [4]. Scores are totaled with a potential range of 6 to 24. We 
chose the STAI-6 because of its predictive validity in assessing changes 
induced by hypothetical choice experiments in patients with cancer.41,45 
Secondary 
Thyroid Cancer 
Fear (adapted) 
Baseline and 
Post-
intervention 
This 8-question quantitative instrument was originally designed to assess fear 
of breast cancer in patients undergoing cancer screening.48 Items are rated on 
a 5-point scale from strongly disagree [1] to strongly agree [5]. We will adapt 
the measure to assess participants’ fear of thyroid cancer. The score ranges 
from 8 to 40. For the original scale, low fear was defined as a total score of 8 
to 15, moderate fear as a score of 16 to 23, and high fear as a score of 24 to 
40. 
Secondary 
Jefferson Scale of 
Patient’s 
Perceptions of 
Physician 
Post-
intervention 
This 5-question quantitative instrument assesses patient perceptions of 
physician empathy.52 Minor adaptations in wording were made to fit the 
video scenario.  Response options are on a 7-point Likert scale ranging from 

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Empathy 
(adapted) 
‘strongly disagree’ [1] to ‘strongly agree’ [7]. Items are summed, with a max 
score of 35, and higher values indicating a perception of more empathy. 
Secondary 
Trust in Physician 
Scale (adapted)  
Post-
intervention 
This 5-question quantitative instrument assesses patient trust in a physician.49 
Response options are 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. 
Tertiary 
Information recall 
(adapted) 
Post-
intervention 
This 5-question quantitative instrument assesses participants’ level of recall 
of information in the video intervention. Questions were modeled after 
Decision Quality Instruments designed by Karen Sepucha, PhD, and colleagues 
at the MGH Health Decision Sciences Center.53,54 Because our questions are 
novel, our exploratory analysis will be determined based on distribution and 
variability of results. Potential analyses include assigning participants a score 
based on how many answers are correct out of 5 and dichotomizing into 
“low” knowledge versus “high” knowledge, and/or comparing mean and 
median scores for the five questions across the two treatment groups.54  
 
8.2 SAFETY ASSESSMENTS 
N/A 
8.3 ADVERSE EVENTS AND SERIOUS ADVERSE EVENTS 
The current study will pose minimal risk to the participants. Participants will be made aware of the risks and 
benefits which they may incur from participating and will have time to ask questions. Further, they will be told 
their participation is voluntary and may leave the study at any time at no harm to them. Although no problems 
or adverse events are expected, any study related adverse events will be documented and reported to the 
local IRB per institutional policy. The PI is responsible for ensuring the safety of the participants and their data. 
All data collected will be used for research purposes only and only the study team members will have access 
to their information. Data will be protected as described previously and any noncompliance will be reported 
immediately. 
8.3.1 DEFINITION OF ADVERSE EVENTS 
8.3.2 DEFINITION OF SERIOUS ADVERSE EVENTS 
8.3.3 CLASSIFICATION OF AN ADVERSE EVENT 
8.3.3.1 
SEVERITY OF EVENT 
8.3.3.2 
RELATIONSHIP TO STUDY INTERVENTION/EXPERIMENTAL MANIPULATION 
8.3.3.3  
EXPECTEDNESS  
8.3.4 TIME PERIOD AND FREQUENCY FOR EVENT ASSESSMENT AND FOLLOW-UP 
8.3.5 ADVERSE EVENT REPORTING  

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8.3.6 SERIOUS ADVERSE EVENT REPORTING  
8.3.7 REPORTING EVENTS TO PARTICIPANTS  
8.3.8 EVENTS OF SPECIAL INTEREST  
8.3.9 REPORTING OF PREGNANCY  
8.4 
UNANTICIPATED PROBLEMS 
8.4.1 DEFINITION OF UNANTICIPATED PROBLEMS 
This protocol uses the definition of Unanticipated Problems as defined by the Office for Human Research 
Protections (OHRP).  OHRP considers unanticipated problems involving risks to participants or others to 
include, in general, any incident, experience, or outcome that meets all of the following criteria: 
• 
Unexpected in terms of nature, severity, or frequency given (a) the research procedures that are 
described in the protocol-related documents, such as the Institutional Review Board (IRB)-approved 
research protocol and informed consent document; and (b) the characteristics of the participant 
population being studied; 
• 
Related or possibly related to participation in the research (“possibly related” means there is a 
reasonable possibility that the incident, experience, or outcome may have been caused by the 
procedures involved in the research); and 
• 
Suggests that the research places participants or others at a greater risk of harm (including physical, 
psychological, economic, or social harm) than was previously known or recognized. 
 
8.4.2  UNANTICIPATED PROBLEMS REPORTING  
The principal investigator will report unanticipated problems (UPs) to the reviewing Institutional Review Board 
(IRB). The UP report will include the following information: 
• 
Protocol identifying information: protocol title and number, PI’s name, and the IRB project number 
• 
A detailed description of the event, incident, experience, or outcome  
• 
An explanation of the basis for determining that the event, incident, experience, or outcome represents 
an UP 
• 
A description of any changes to the protocol or other corrective actions that have been taken or are 
proposed in response to the UP 
 
To satisfy the requirement for prompt reporting, UPs will be reported using the following timeline:   
• 
Any UP will be reported to the IRB and to the funding agency within 14 business days of the 
investigator becoming aware of the problem  
• 
All UPs should be reported to appropriate institutional officials (as required by an institution’s written 
reporting procedures), the supporting agency head (or designee), and the Office for Human Research 
Protections (OHRP) within 14 business days of the IRB’s receipt of the report of the problem from the 
investigator 
 
8.4.3 REPORTING UNANTICIPATED PROBLEMS TO PARTICIPANTS  

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N/A 
9 
STATISTICAL CONSIDERATIONS  
9.1 
STATISTICAL HYPOTHESES 
Primary Endpoint: We hypothesize that emotionally supportive communication will decrease patient preference 
for total thyroidectomy immediately after watching the video. 
 
Secondary Endpoints: We hypothesize that emotionally supportive communication will decrease anxiety and 
thyroid cancer fear and increase trust, perceived empathy, and decisional confidence immediately after 
watching the video. 
 
Tertiary/exploratory: We hypothesize that emotionally supportive communication will increase information recall 
immediately after watching the video. 
 
9.2 
SAMPLE SIZE DETERMINATION 
We assume based on existing data that the proportion of participants choosing total thyroidectomy will be 0.89 
and estimate the sample size needed for 90% power to detect a proportion lower than 89%. With a sample of 
n=59 in each group, we will be able to detect risk differences of -25% and medium effect sizes of -0.60 with 
90% power using a 2-sided test (chi square for binary outcome) with Type I error rate alpha= 0.05. The UW 
Thyroid Nodule Biopsy clinic performs over 500 biopsies annually, of which approximately 70% are benign. 
The UW Radiology clinic performs 400 biopsies per year on patients with benign thyroid nodules. 
 
We anticipate missing data will be very low as the study is expected to be completed in one sitting. 
9.3 
POPULATIONS FOR ANALYSES 
We will perform a two-group intent to treat analysis based on the intervention randomization. 
9.4 
STATISTICAL ANALYSES 
9.4.1 GENERAL APPROACH 
For descriptive statistics, categorical and continuous data will be presented as percentages, means with 
standard deviations, median, and range. For inferential tests, we will use 2-sided tests with Type I error rate 
alpha=0.05 for statistical significance. Covariates are specified below.  Checks for assumptions of normality 
will be performed. If data are not normal, nonparametric tests will be used. 
 
9.4.2 ANALYSIS OF THE PRIMARY ENDPOINT(S) 
The primary endpoint, treatment choice, is a binary scale. It will be measured once immediately after the 
intervention. 

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We will calculate distributional characteristics and perform a two-group intent to treat analysis for this binary 
endpoint using conditional logistic regression to account for stratification by sex. The Type I error rate alpha= 
0.05. 
9.4.3 ANALYSIS OF THE SECONDARY ENDPOINT(S) 
We will calculate distributional characteristics and perform a two-group intent to treat analysis for continuous or 
ordinal endpoints using 2-sided t-tests or analysis of variance (ANOVA) with Type I error rate alpha= 0.05, and 
risk differences or mean differences with confidence intervals for quantification and estimation of effect. 
 
Secondary 
endpoint 
Dependent 
on primary 
endpoint? 
Repeated 
measure? 
Scale 
Statistical procedures 
Decision confidence 
No 
No 
Continuous 
2-sided t-tests 
Anxiety – STAI Brief 
No 
Yes: Pre and Post 
Continuous 
2-sided t-tests 
Thyroid Cancer Fear  No 
Yes: Pre and Post 
Continuous and Ordinal 
2-sided t-tests and ANOVA 
Patient Perception 
of Physician 
Empathy  
No 
No 
Continuous 
2-sided t-tests 
Trust in Physician 
No 
No 
Continuous 
2-sided t-tests 
Information recall  
No 
No 
Continuous  
2-sided t-tests 
 
9.4.4 SAFETY ANALYSES 
N/A 
9.4.5 BASELINE DESCRIPTIVE STATISTICS 
We will describe baseline characteristics such as age, sex, race, state anxiety, thyroid cancer fear, and clinical 
history such as hypothyroidism overall and by treatment arm, consistent with CONSORT checklist criteria.  
9.4.6 PLANNED INTERIM ANALYSES  
N/A 
9.4.7 SUB-GROUP ANALYSES 
For the primary endpoint, we will determine whether differences exist in response to the intervention by age, 
sex, race/ethnicity, and level of education. Prior data suggests disparities may exist in treatment received for 
actual patients with thyroid cancer and these characteristics. We will also determine if differences exist by 
clinical characteristics, such as hypothyroidism, thyroid-related symptoms, personal history of cancer, nodule 
characteristics, time of diagnosis, and medical use tendencies, again based on the published literature in 
patients with thyroid or other low-risk cancers. 
9.4.8 TABULATION OF INDIVIDUAL PARTICIPANT DATA 

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Individual participant data will not be listed by measure and time point. 
9.4.9 EXPLORATORY ANALYSES 
We will explore the association of the secondary outcomes of decision confidence, anxiety, and thyroid 
cancer fear on the primary outcome: treatment choice. We will also perform sub-group analysis for the 
secondary end points by age, sex, race/ethnicity, level of education, hypothyroidism, thyroid-related symptoms, 
personal history of cancer, nodule characteristics, time of diagnosis, and medical use tendencies. 
10 SUPPORTING DOCUMENTATION AND OPERATIONAL CONSIDERATIONS 
10.1  REGULATORY, ETHICAL, AND STUDY OVERSIGHT CONSIDERATIONS 
10.1.1 INFORMED CONSENT PROCESS 
10.1.1.1 CONSENT/ASSENT AND OTHER INFORMATIONAL DOCUMENTS PROVIDED TO 
PARTICIPANTS 
All potential participants (i.e. adults getting thyroid nodule biopsies) will receive a letter with a URL for 
uwchoices.org, and an informational brochure about the study. Potential participants who are confirmed to be 
eligible will be given a link to complete the study on Qualtrics. After passing eligibility screening questions, they 
will see an information page describing the study intervention, study procedures, and risks. The information 
page will tell participants to contact the study team with any additional questions about the study. 
10.1.1.2 CONSENT PROCEDURES AND DOCUMENTATION 
This clinical trial is a hypothetical choice experiment that presents no more than minimal risk of harm to 
subjects. It involves no procedures for which written consent is normally required outside of the research 
context. Therefore we will have a waiver of signed consent and present an information page to participants on 
Qualtrics. Participants will be asked to contact the study team with any questions before proceeding to the 
study. At the end of the information page on Qualtrics, participants will told that clicking to the next page 
indicates their consent to participate in the study. 
10.1.2 STUDY DISCONTINUATION AND CLOSURE 
This study may be temporarily suspended or prematurely terminated if there is sufficient reasonable cause. 
Written notification, documenting the reason for study suspension or termination, will be provided by the 
suspending or terminating party to investigator, funding agency, and regulatory authorities. If the study is 
prematurely terminated or suspended, the Principal Investigator (PI) will promptly inform the Institutional 
Review Board (IRB), and sponsor/funding agency and will provide the reason(s) for the termination or 
suspension. 
 
Circumstances that may warrant termination or suspension include, but are not limited to: 
• 
Determination of unexpected, significant, or unacceptable risk to participants 
• 
Insufficient compliance of study staff to the protocol   (i.e., significant protocol violations) 

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• 
Data that are not sufficiently complete and/or evaluable 
 
The study may resume once concerns about safety, protocol compliance, and data quality are addressed, and 
satisfy the funding agency, sponsor, IRB, or other relevant regulatory or oversight bodies (OHRP, DSMB). 
10.1.3 CONFIDENTIALITY AND PRIVACY  
All research activities will be conducted in as private a setting as possible. 
 
Participant confidentiality and privacy is strictly held in trust by the participating investigators, their staff, and 
the funding agency. This confidentiality is extended to the data being collected as part of this study. Data that 
could be used to identify a specific study participant will be held in strict confidence within the research team.  
 
To ensure confidentiality, study data will only be accessed by personnel on the research team. Only the 
minimum amount of information that is necessary to achieve the aims of the research will be collected. All 
information obtained and associated data files will be confidential and will be kept in a locked file in a locked 
office or on a secure, password-protected server within the Department of Surgery network, which is protected 
by a firewall that ensures the privacy of the network. Any paper records will be kept in a locked cabinet in a 
locked office that only study staff have access to. Access to the information is limited to the study team, all of 
whom have completed the requisite human subjects/Health Insurance Portability and Accountability Act 
(HIPAA) training and have been given valid access to electronic medical records. 
 
Patient information is limited to the minimum necessary to screen for eligibility, recruit patients, and mail 
participant incentives. The study participant’s contact information will be securely stored for internal use during 
the study. We will also use names, MRNs, and dates/times of appointments. Identifying information will be 
separated from study data. Once the study is complete, all PHI will be destroyed. At the end of the study, all 
records will continue to be kept in a secure location for 7 years or longer. 
 
Confidentiality will be protected further by: 1) using a participant log form that contains only the minimum 
necessary protected health information (PHI) concerning participants and storing this log on a secure 
password-protected server; 2) coding data collection forms with a consecutive participant number that is not 
derived from any participant personal identifiers and linking that data collection form to the participant log; 3) 
storing the participant log and data collection forms separately; and 4) not sharing PHI with anyone outside the 
research team. It is highly likely that these measures will result in avoidance of breach of confidentiality outside 
of the research. In addition, the data to be collected are not sensitive to participants. 
 
Survey data will be stored on a secure Department of Surgery server. Data will be shared with Drs. Susan Pitt 
and Megan Haymart at the University of Michigan to assist with analysis. The data will not include identifiable 
information or the keycode. This information will be shared using the secure server file transfer service 
maintained by the UW Department of Surgery at t.surgery.wisc.edu. This is a secure, password-protected 
system and files transferred through it are automatically deleted from the service 7 days after upload. 
 
It is NIH policy that the results and accomplishments of the activities that it funds should be made available to 
the public. The PI will ensure all mechanisms used to share data will include proper plans and safeguards for 

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the protection of privacy, confidentiality, and security for data dissemination and reuse (e.g., all data will be 
thoroughly de-identified and will not be traceable to a specific study participant). Plans for archiving and long-
term preservation of the data will be implemented, as appropriate.  
10.1.4 FUTURE USE OF STORED SPECIMENS AND DATA  
Data collected for this study will be analyzed and stored at the University of Wisconsin. After the study is 
completed, the de-identified, archived data may be transmitted to and stored at a data repository for use by 
other researchers including those outside of the study. Permission to transmit data to a data repository will be 
included in the informed consent.  
 
We will obtain IRB approval for any future research projects that might use data from this study. 
10.1.5 KEY ROLES AND STUDY GOVERNANCE 
Principal Investigator 
Corrine Voils, PhD, Professor of Surgery 
University of Wisconsin-Madison  
600 Highland Ave, K6/100 CSC, Madison, WI 53792-1690 
608-262-9636 
voils@surgery.wisc.edu 
 
Participants will be given information for reporting study misconduct. The following language will be included 
on the information page preceding the study: “If you have any questions about your rights as a research 
subject or have complaints about the research study or study team, contact UW Health Patient Relations at 
608-263-8009. The Patient Relations Representatives work with research subjects to address concerns about 
research participation and assist in resolving problems.”  
10.1.6 SAFETY OVERSIGHT 
The current study will pose minimal risk to the participants. Participants will be made aware of the risks and 
benefits which they may incur from participating and will have time to ask questions. Further, they will be told 
their participation is voluntary and may leave the study at any time at no harm to them. 
 
The PI will be directly responsible for identifying and reporting all adverse events to the IRBs and funding 
agency as appropriate. Study staff will report any adverse event or unanticipated problem to the PIs 
immediately. The PIs will report any serious, unexpected, and study-related adverse event or unanticipated 
problem to the local University of Wisconsin (UW) Minimal Risk IRB according to the institution’s requirements. 
The IRB will review all adverse events during continuing review, which will likely occur annually. Given that our 
intervention is a hypothetical choice experiment for patients who have benign thyroid nodules, rather than a 
clinical intervention, we do not anticipate any problems. 
 
We will use the UW’s Institute for Clinical and Translational Research’s (ICTR) Data Monitoring Committee 
(DMC). ICTR is UW’s NIH Clinical and Translational Science Award and provides extensive research support. 

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The ICTR DMC will ensure appropriate measures are in place to promote subject safety, research integrity, 
and compliance with federal regulations and local policies. 
 
The UW ICTR DMC is comprised of experienced members (core plus ad hoc) with expertise required to 
oversee this study. The DMC members will review protocol-specific reports created by statisticians using data 
provided by the study team. These standard reports will include an overview of study objectives, a review of 
actual and projected accrual rates, an evaluation of patient demographics for balance of randomization, and a 
summary of the number and seriousness of adverse events. Source documents may be reviewed to allow the 
DMC to independently judge whether the overall integrity and conduct of the protocol remain acceptable based 
on data provided and reported by the PI. The DMC will make recommendations to the Principal Investigator 
that could include actions of continuation, modification, suspension, or termination. 
 
In providing oversight for the conduct of this study, the ICTR DMC will meet with the PI prior to data collection, 
after the first few participants have been enrolled, and at least biannually thereafter to review enrollment and 
adverse events. Additional meetings will be scheduled as determined by the DMC or as requested by the PI. 
Because this study is minimal risk, there are no planned interim analyses or predefined stopping points due to 
futility, efficacy, or harms. We will submit all reportable events to the DMC and the UW Minimal Risk IRB in 
accordance with their reporting guidelines. 
10.1.7 CLINICAL MONITORING 
N/A 
10.1.8 QUALITY ASSURANCE AND QUALITY CONTROL 
The study team will perform internal quality management of study conduct, data collection, documentation and 
completion. Quality control (QC) procedures will be implemented as follows: 
 
Screening and recruitment data will originate in the EHR (see Section 10.1.9, Data Handling and Record 
Keeping) and will ultimately be entered into the study database in REDCap. To ensure accuracy, site staff will 
compare a representative sample of source data against the database, targeting key data points in that review. 
 
Protocol Deviations – The study team will review protocol deviations on an ongoing basis and will implement 
corrective actions when the quantity or nature of deviations are deemed to be at a level of concern. 
 
Should independent monitoring become necessary, the PI will provide direct access to source data/documents, 
and reports for the purpose of monitoring and auditing by the funding agency, and inspection by local and 
regulatory authorities. 
10.1.9 DATA HANDLING AND RECORD KEEPING  
10.1.9.1 DATA COLLECTION AND MANAGEMENT RESPONSIBILITIES  

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Data collection will be the responsibility of the clinical trial staff under the supervision of the principal 
investigator. The investigator will be responsible for ensuring the accuracy, completeness, legibility, and 
timeliness of the data reported. 
 
For this study there will be no hardcopies of data, study visit worksheets, or CRFs. As the study is completed 
by participants online in Qualtrics, all data for baseline measures and outcome measures will be entered into 
Qualtrics by the study participants themselves.  
 
Screening and recruitment data will be recorded by study staff in REDCap (Research Electronic Data Capture), 
a 21 CFR Part 11-compliant data capture system provided by the Department of Surgery at UW-Madison. The 
data system includes password protection and internal quality checks, such as automatic range checks, to 
identify data that appear inconsistent, incomplete, or inaccurate. Clinical data relevant to screening and 
recruitment will be entered directly from the EMR. 
 
REDCap and Qualtrics both provide export procedures for seamless data downloads to Excel and common 
statistical packages (SPSS, SAS, Stata, R). 
10.9.1.2 STUDY RECORDS RETENTION  
Study documents will be retained for a minimum of 3 years after the date of Federal Financial Report (FFR) 
submission. These documents should be retained for a longer period, however, if required by local regulations. 
No records will be destroyed without the written consent of the funding agency, if applicable. It is the 
responsibility of the funding agency to inform the investigator when these documents no longer need to be 
retained. 
10.1.10 PROTOCOL DEVIATIONS   
This protocol defines a protocol deviation as any noncompliance with the clinical trial protocol or International 
Council on Harmonisation Good Clinical Practice (ICH GCP) requirements. The noncompliance may be either 
on the part of the participant, the investigator, or the study staff. As a result of deviations, corrective actions will 
be developed and implemented promptly.  
 
These practices are consistent with ICH GCP:  
• 
Section 4.5 Compliance with Protocol, subsections 4.5.1, 4.5.2, and 4.5.3  
• 
Section 5.1 Quality Assurance and Quality Control, subsection 5.1.1  
• 
Section 5.20 Noncompliance, subsections 5.20.1, and 5.20.2.  
 
It will be the responsibility of the principal investigator to use continuous vigilance to identify and report 
deviations within 14 working days of identification of the protocol deviation, or within 14 working days of the 
scheduled protocol-required activity. All deviations will be addressed in the screening and recruitment 
database, and reported to National Cancer Institute Program Official. Protocol deviations will be sent to the 
reviewing Institutional Review Board (IRB) per their policies. The principal investigator will be responsible for 
knowing and adhering to the reviewing IRB requirements. 
10.1.11 PUBLICATION AND DATA SHARING POLICY  

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Protocol version 11/8/21 
 
This study will be conducted in accordance with the following publication and data sharing policies and 
regulations: 
 
National Institutes of Health (NIH) Public Access Policy, which ensures that the public has access to the 
published results of NIH funded research. It requires scientists to submit final peer-reviewed journal 
manuscripts that arise from NIH funds to the digital archive PubMed Central upon acceptance for publication. 
 
This study will comply with the NIH Data Sharing Policy and Policy on the Dissemination of NIH-Funded 
Clinical Trial Information and the Clinical Trials Registration and Results Information Submission rule. As such, 
this trial will be registered at ClinicalTrials.gov, and results information from this trial will be submitted to 
ClinicalTrials.gov. In addition, every attempt will be made to publish results in peer-reviewed journals. Data 
from this study may be requested from other researchers after the completion of the primary endpoint by 
contacting Susan Pitt and/or accessing a data repository.  Considerations for ensuring confidentiality of these 
shared data are described in Section 10.1.3. 
10.1.12 CONFLICT OF INTEREST POLICY 
The independence of this study from any actual or perceived influence, is critical. Therefore, any actual conflict 
of interest of persons who have a role in the design, conduct, analysis, publication, or any aspect of this trial 
will be disclosed and managed. Furthermore, persons who have a perceived conflict of interest will be required 
to have such conflicts managed in a way that is appropriate to their participation in the design and conduct of 
this trial. The study leadership in conjunction with the National Cancer Institute has established policies and 
procedures for all study group members to disclose all conflicts of interest and will establish a mechanism for 
the management of all reported dualities of interest. 
10.2 ADDITIONAL CONSIDERATIONS 
N/A 
10.3 ABBREVIATIONS AND SPECIAL TERMS 
AE 
Adverse Event 
CFR 
Code of Federal Regulations 
CONSORT Consolidated Standards of Reporting Trials 
CRF 
Case Report Form 
DSMB 
Data Safety Monitoring Board 
GCP 
Good Clinical Practice 
HIPAA 
Health Insurance Portability and Accountability Act  
ICH 
International Council on Harmonisation  
IRB 
Institutional Review Board 
NCT 
National Clinical Trial 
NIH  
National Institutes of Health 
OHRP 
Office for Human Research Protections 
PI 
Principal Investigator 

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QC 
Quality Control 
SAE 
Serious Adverse Event 
UP 
Unanticipated Problem 
US 
United States 
 
 
 

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10.4 PROTOCOL AMENDMENT HISTORY 
The table below is intended to capture changes of IRB-approved versions of the protocol, including a description 
of the change and rationale. A Summary of Changes table for the current amendment is located in the Protocol 
Title Page.  
 
Version 
Date 
Description of Change  
Brief Rationale 
2 
Nov 8, 2021 
Added 1 South Park as a potential 
clinic from which to recruit 
Flexibility to recruit from all 
UW biopsy clinics if needed 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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