Escape Room: A Gamified Approach to Learning About Cancer Nutrition Information
Phase: NA
Conditions: Anatomic Stage I Breast Cancer AJCC v8, Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage III Breast Cancer AJCC v8
Sponsor: Fred Hutchinson Cancer Center

 
 
Official Title: 
Escape Room: A gamified approach to learning about 
cancer nutrition information  
NCT Number: 
NCT06193070 
Document Type:  
Study Protocol and Statistical Analysis Plan 
Date of the 
Document: 
2/7/2024  
 
 
 

FRED HUTCHINSON CANCER CENTER
Current version: Version 2 01/17/2024
Previous versions
Version 1
11/28/2023
Title of Protocol:
Escape Room: A gamified approach to learning about cancer nutrition information
Principal Investigator:
Megan Shen, PhD
Associate Professor, Clinical Research Division & 
Public Health Sciences, Fred Hutch
(206) 667-4172
Co-Investigators:
Chris Coward, MPA, MA
Senior Principal Research Scientist
Information School, University of Washington
(206) 437-4592
Lynn Symonds, MD
Assistant Professor and Medical Oncologist
Fred Hutchinson Cancer Center
Jin Ha Lee, PhD
Associate Professor
Information School, University of Washington
(206) 685-0153
Julie Kientz, PhD
Professor & Chair
Department of Human Centered Design and 
Engineering, University of Washington
(206) 221-0641
Rachel Moran, PhD
Research Scientist
Information School, University of Washington
(213) 222-7337
Biostatistician:
Megan Shen, PhD
Associate Professor, Clinical Research Division, Fred 
Hutch
(206) 667-4172
Research Staff:
Claudia De Los Santos
Research Project Manager, Clinical Research Division, 
Fred Hutch
(206) 667-1565
Trevor Bender
Clinical Research Coordinator, Clinical Research 
Division, Fred Hutch
(206) 667-5507
Maya Pande
Clinical Research Coordinator, Clinical Research 
Division, Fred Hutch
(206) 667-6844
SPONSOR: Fred Hutchinson Cancer Center
Emergency (24-hour) phone number: office (206) 667-4172, mobile (281)615-5304
Fred Hutch IRB
Approved 
2/7/2024

Protocol #: RG1123830
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PROTOCOL SYNOPSIS
Protocol Title
Escape Room: A gamified approach to learning about cancer nutrition information
Protocol Number
Protocol Sponsor
Fred Hutchinson Cancer Center
Trial Phase
Early Phase/Phase 1
Trial Type
Single arm, open trial
Study Objectives
Aim 1
To evaluate the feasibility, acceptability, and usability of the escape room game 
intervention among breast cancer patients in active treatment.
Exploratory Aim 2
To test preliminary efficacy of the escape room game intervention for increasing 
awareness about types of online misinformation, concern about misinformation, 
and confidence in the ability to identify misinformation as well as decreasing cancer 
nutrition misinformation beliefs.
Study Design
Feasibility study (Aims 1 and 2)
Population
Patients with a current diagnosis of breast cancer (Stages I-III) and in active 
treatment for breast cancer.
Primary Endpoints
Study design and intervention feasibility, acceptability, usability, and potential 
efficacy of an escape room game will be measured by assessing accrual rate, 
satisfaction, and usability of the escape room game.
Secondary Endpoints
Awareness and concern about cancer nutrition misinformation and beliefs about 
cancer nutrition.
Type of Control
N/A (single arm, open trial)
Treatment Group
Escape room game
Treatment Schedule
Intervention (Escape Room Game):
-
Pre-game baseline survey
-
Play the misinformation escape room game intervention in groups of 
approximately 5 and completed debrief exit interview
-
Post-game survey
Number of participants
N=40 (n=5 breast cancer patients per group)
Estimated duration of 
study (per participant)
4 weeks
Duration of 
participation (per 
participant)
90 minutes
ABBREVIATIONS
Include a table of abbreviations as needed.
EHR
Electronic health record
Fred Hutch
Fred Hutchinson Cancer Center
UW
University of Washington
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Table of Contents
1.0 GENERAL INFORMATION ...............................................................................................................................................................4
1.1 Protocol Title...............................................................................................................................................................................4
1.2 Sponsor Information...................................................................................................................................................................4
1.3 Investigator Information.............................................................................................................................................................4
1.4 Participating Sites ......................................................................................................................................................................4
2.0 INTRODUCTION TO THE PROTOCOL..........................................................................................................................................5
2.1 Introduction .................................................................................................................................................................................5
2.2 Background.................................................................................................................................................................................5
2.3 Risks/Benefits .............................................................................................................................................................................6
3.0 OVERVIEW OF STUDY ....................................................................................................................................................................6
3.1 Study Objectives ........................................................................................................................................................................6
3.2 Specific Aims ..............................................................................................................................................................................6
3.3 Study Population ........................................................................................................................................................................7
3.4 Study Design...............................................................................................................................................................................7
3.5 Name of Sponsor/Funding Source ..........................................................................................................................................8
4.0 PARTICIPANT ELIGIBILITY .............................................................................................................................................................8
4.1 Inclusion Criteria (Patients).......................................................................................................................................................8
5.0 PARTICIPANT REGISTRATION......................................................................................................................................................9
6.0 STUDY PROCEDURES AND INTERVENTION ............................................................................................................................9
6.1 Recruitment strategies...............................................................................................................................................................9
6.2 Estimated Accrual ......................................................................................................................................................................9
6.3 Consent and Data Collection..................................................................................................................................................10
7.0 PARTICIPANT EVALUATION.........................................................................................................................................................11
7.1 Study Questionnaires and Assessments..............................................................................................................................11
7.2 Semi-structured Qualitative Interview ...................................................................................................................................12
8.0 PARTICIPANT WITHDRAWAL.......................................................................................................................................................12
9.0 CONCOMITANT MEDICATIONS...................................................................................................................................................12
10.0 ADVERSE EVENTS.......................................................................................................................................................................12
10.1 Adverse Event ........................................................................................................................................................................12
10.2 Adverse Event Grading Scale..............................................................................................................................................12
10.3 Serious Adverse Event (SAE)..............................................................................................................................................13
11.0 DATA AND SAFETY MONITORING PLAN................................................................................................................................14
12.0 DATA MANAGEMENT/CONFIDENTIALITY ..............................................................................................................................14
13.0 STATISTICAL CONSIDERATIONS.............................................................................................................................................14
13.1 Study Design ..........................................................................................................................................................................14
13.2  Analyses.................................................................................................................................................................................14
13.4 Ethnic and Gender Distribution Chart .................................................................................................................................15
14.0 INVESTIGATOR OBLIGATIONS .................................................................................................................................................16
15.0 REFERENCES................................................................................................................................................................................17
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1.0 GENERAL INFORMATION
1.1 Protocol Title
Escape Room: A gamified approach to learning about cancer nutrition information 
1.2 Sponsor Information
Fred Hutchinson Cancer Center
1.3 Investigator Information
Megan Shen, PhD, office (206) 667-4172, mobile (281) 615-5304
Email: mshen2@fredhutch.org  
Chris Coward, office (206) 437-4592
Email: ccoward@uw.edu
1.4 Participating Sites
Fred Hutchinson Cancer Center
University of Washington
Fred Hutch IRB
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2.0 INTRODUCTION TO THE PROTOCOL
2.1 Introduction
The described study will be conducted in compliance with all applicable IRB requirements and associated 
Federal regulations.
The overarching goal of this research study is to pilot test an escape room intervention for cancer nutrition 
misinformation designed to reduce vulnerability to believing cancer nutrition misinformation among breast 
cancer patients. The results of this pilot study will provide necessary preliminary data to apply for an NIH R01 
level application to conduct a full randomized controlled trial (RCT) of the escape room game as a potential 
intervention to increase resistance to cancer nutrition misinformation.
Chris Coward (Co-I) and Jin Ha Lee (Co-I) at the University of Washington (UW), along with collaborator 
Lindsay Morse (Puzzle Break), previously developed an online misinformation escape room as an interactive 
learning experience designed to focus on the psychological dimensions of misinformation. Escape rooms are 
live action-adventure games where teams work cooperatively to solve a series of puzzles. Initial results were 
encouraging,1  indicating the game successfully increased awareness of misinformation and confidence in 
identifying it. Based on this experience, the UW research team and Megan Shen (PI) at Fred Hutch partnered 
to develop an escape room for cancer nutrition misinformation. This project builds off Dr. Shen’s key strengths 
as a cancer communication researcher and builds on a novel and relevant area of public health – combating 
cancer misinformation. Expertise from oncologists and cancer nutrition experts about the types of 
misinformation they encounter in their work with patients was also incorporated into developing the escape 
room content.
2.2 Background 
The COVID-19 pandemic has brought to the forefront both the prevalence and dangers of health 
misinformation among the U.S. population. Misinformation, or communication about health information that is 
inaccurate or false, has serious health consequences for those that believe it.2 The rise of the access to and 
use of the various sources of information on the internet such as websites and social media has caused the 
spread of misinformation and disinformation to grow rapidly,3 creating far-reaching negative consequences 
on health outcomes. Cancer misinformation, in particular, has become an increasingly prevalent issue that 
poses a real public health threat to the many cancer patients in the U.S.4 One area of this landscape is 
cancer nutrition misinformation, which can propel patients into engaging in health behaviors that may 
negatively affect their treatment and survival outcomes or avoiding positive health behaviors that may benefit 
them.
Misinformation around nutrition is prevalent. One study found that health claims such as prevent (41.8%), 
treat (27.2%), and cure (10.7%) cancer and phrases such as “anti-cancer” or “cancer-fighting” were common 
among recipes posted to the website Pinterest.5 Prior research indicates that core components of information 
seeking such as trustworthiness are critical to determining peoples’ likelihood of believing and acting upon 
misinformation.2 However, in the context of online information where misinformation thrives, it can be very 
difficult to determine whether a source is truly trustworthy or accurate. Thus, in turn, makes patients highly 
vulnerable to cancer nutrition misinformation through online routes of obtaining information. Because proper 
nutrition is critical to patients being able to receive proper cancer treatment and manage symptoms 
associated with treatment, it is critical that patients receive access to accurate cancer nutrition information.
Unfortunately, education alone is rarely an effective form of intervention for combating misinformation. This 
project will build on prior stages of research aiming to develop a gamified approach to building resilience to 
public health misinformation, with a specific focus on cancer nutrition misinformation. Gamification is a 
promising new target for combating misinformation, as it provides a way to help users learn new skills (such 
as developing awareness of and resistance to misinformation) through the psychologically non-threatening 
form of play.6 This approach involves the creation of an escape room game that will help people detect and 
resist misinformation through an immersive learning experience which focuses on cognitive biases, emotional 
triggers, and other affective attributes of misinformation.
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2.3 Risks/Benefits
Risks

Discomfort. There may be some emotional discomfort in discussing misinformation and disinformation 
rhetoric in relation to health and nutrition related topics. We do not anticipate that this discomfort will be 
exacerbated by a group setting. Indeed, misinformation researchers use group reflection meetings to 
mitigate the emotional impact of being exposed to misleading and problematic information. The UW’s 
Center for an Informed Public builds group reflection meetings into research timelines for their student 
researchers as group reflection on misleading information has allowed researchers to maintain clarity in 
confusing information environments and provided them with a supportive space to share any concerns 
around the information they encounter. We anticipate that this same framework will apply to the cancer 
patient population. Further, the Misinformation Escape Room has been designed using expert insight from 
in-depth interviews with oncologists and cancer nutrition experts and will be, prior to player testing, 
evaluated by the same experts to ensure it is appropriate for this specific patient population. Finally, we 
have proper oversight and monitoring of any adverse events created by participating in group settings in 
order to ensure an accurate oversight of and response to any potential distress is part of the research plan. 
Participants can decline to complete the intervention, survey or interview or skip questions at their own 
discretion. 

Loss of privacy. A risk of taking part in this study is the possibility of a loss of confidentiality. Loss of 
confidentiality includes having your personal information shared with someone who is not on the study 
team and was not supposed to see or know about your information. We will try to protect your information, 
but we cannot guarantee privacy. The plans for keeping your information private are described in the 
'confidentiality' section of this consent form.
Benefits

Knowledge gained. Although the study may not benefit participants directly, this study could provide 
important information on how to address issues of cancer misinformation. Because risks to participants in 
this study are minor, the risks are reasonable in relation to the expected benefits.

Financial compensation. Participants will receive $75 for playing the game, participating in a post-game 
brief interview, and completing baseline and post-intervention surveys.
3.0 OVERVIEW OF STUDY
3.1 Study Objectives
The overarching goal of this research study is to pilot test an escape room intervention for cancer nutrition 
misinformation designed to reduce vulnerability to believing cancer nutrition misinformation among breast 
cancer patients. The main aim (Aim 1) is to determine the potential feasibility, acceptability, and usability of the 
intervention. The secondary aim (Aim 2) is exploratory in nature and designed to determine if there are 
potential changes in pre/post outcome measures (increasing awareness about types of online misinformation, 
concern about misinformation, and confidence in the ability to identify misinformation). The results of this pilot 
study will provide necessary preliminary data to apply for an NIH R01 level application to conduct a full 
randomized controlled trial (RCT) of the escape room game as a potential intervention to increase resistance 
to cancer nutrition misinformation.
3.2 Specific Aims
Aim 1
To evaluate the feasibility (1a), acceptability (1b), and usability (1c) of the escape room game intervention 
among breast cancer patients in active treatment.
Hypothesis 1a: For feasibility, ≥50% of screened eligible patients7 will enroll in the study.
Hypothesis 1b: For acceptability, ≥70% of patients will rate the intervention as satisfactory (e.g., a “7” or 
higher on a 10-point Likert scale) on a 10-point Likert-scale item assessing how satisfied they are with 
the intervention and will recommend this game to others.
Hypothesis 1c: For usability, ≥70% of patients will have a System Usability Score (SUS) of ≥68.
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Exploratory Aim 2
To test preliminary efficacy of the escape room game intervention for increasing awareness about types of 
online misinformation, concern about misinformation, and confidence in the ability to identify misinformation 
as well as decreasing cancer nutrition misinformation beliefs.
Hypothesis 2: Cancer patients will report increases in awareness about types of online misinformation, 
concern about misinformation, and confidence in the ability to identify misinformation and reductions 
in believing cancer nutrition misinformation from pre- to post-intervention.
3.3 Study Population
The study includes patients with a current diagnosis of breast cancer and/or are receiving treatment for breast 
cancer.
3.4 Study Design
Intervention Description
The intervention is an escape room game designed to teach participants how to discern whether cancer 
nutrition information is accurate or may potentially be misinformation. The content of the game focuses on 
common tactics used to spread misinformation such as cherry-picking study data, using questionable “expert” 
influencers, overgeneralization, and misleading headlines. The game is designed to be played in groups of 
approximately 5, in which players work together to solve a series of puzzles that teaches them about the 
potential risks of misinformation online. In the present study, the intervention will follow a fictional company 
(“ZenFusion Wellness") that is trying to sell its nutritional product (The “Evergreen Diet”) in order to make 
profits. Throughout the game, players are immersed in the narrative while solving puzzles to learn key themes 
such as the need to talk to their doctors and look for scientific studies and FDA approvals as well as avoid fads 
and trends, miracle cures, anecdotal evidence, and targeted and clickbait ads. For example, in one puzzle,  
participants are asked to “decode” the sensationalist ad headlines and use the codebook to find a password. 
The headlines are designed to mimic programmatic ads often seen at the bottom of websites with text such as 
“This one simple trick will help you heal naturally” and “This woman conquered breast cancer through diet 
alone.” Figure 1 provides a screenshot of the puzzle. Below, we also outline all five puzzles included in the 
game.
Figure 1. Escape Room Puzzle
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
Puzzle 1: This puzzle is a visual representation of the spread of strong emotions via social media. 
Players are shown an unfinished grid puzzle with smiley face emojis depicting different emotions. 
Players are asked to rearrange pieces of the puzzle, and after doing so, an image will be revealed that 
gives a clue to the secret password. When the secret password is entered correctly, the game 
continues. 

Puzzle 2: This puzzle is primarily text-based and reflects tactics of misleading advertising. It provides 
several partially finished headlines related to nutrition. Players are asked to work together to decode 
the letters / words (e.g., “The Cancer-Free Diet: Eat your way to >%!*##*+$” when solved becomes 
“The Cancer-Free Diet: Eat your way to remission”). When solved correctly, players will be able to 
decode the secret password.

Puzzle 3: This puzzle is in two parts and reflects tactics used to cherry pick data and only present 
successful outcomes. Part One is a matching game, where players flip over cards and make pairs 
(each image has a food and a person). Once matched successfully, players begin Part Two, where 
they match the foods with people that were linked in Part One. This reveals a secret password.

Puzzle 4: This is a Hashi bridge puzzle that requires players to connect nodes in a network. Each 
player works on their own individual puzzle, connecting dots with one or two lines. Correctly solved 
puzzles will visually form a letter—all four letters revealed spell out the secret password.

Puzzle 5: This puzzle is a maze and represents individual patient health journeys and how to navigate 
through uncertainty. Each player solves their own maze by clicking on tiles that will form the correct 
path associated with images that correspond to parts of the care journey that should be adopted (e.g., 
scientific studies, consultations with medical professionals) rather than those that should be avoided 
(e.g., fads and trends, miracle cures). Once all players solve their maze, the secret password is 
revealed.

Final Task: Before the game ends, players are asked to select an option to finish the story. All options 
are acceptable and lead to winning the game. Players’ discussion of options will preface the next stage 
of the intervention, which is the hosted debrief.
The game is designed to be played only once by players. It is a collaborative group appropriate for 3-5 players 
to play together. The length of the game is approximately 30-45 minutes depending on how quickly participants 
solve the puzzles. The game will be played online via a video-calling platform (i.e. Zoom).
At the end of the game, players are expected to be more aware of possible nutrition misinformation that may 
be online and to be wiser consumers of online information.
Eight groups of approximately 5 participants (n=40 total) will be recruited and grouped together. Participants 
will be provided a baseline survey prior to their attendance at the session. Participants will play the 
misinformation escape room game together with the group and take part in a debrief with a member of the 
research team immediately after completing the game. Finally, participants will be provided with a post-game 
survey to complete after the game and debrief session.
3.5 Name of Sponsor/Funding Source
Fred Hutchinson Cancer Center, Cancer Consortium Grant (NIH/NCI)
4.0 PARTICIPANT ELIGIBILITY
4.1 Inclusion Criteria (Patients)
Inclusion Criteria:
1) Age 18 years of age or older.
2) English speaking.
3) Able to provide informed consent.
4) Have access to a computer (desktop or laptop).
5) Have been previously diagnosed with breast cancer (Stages I-III) and currently in active 
treatment for breast cancer.
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Exclusion Criteria:
1) No other exclusion criteria.
5.0 PARTICIPANT REGISTRATION
When potential study participants are identified, Fred Hutch research staff will enter their information into the 
secure REDCap database, as well as into OnCore CTMS. A complete, written or electronically signed, study 
consent and HIPAA authorization form are required for registration.  
STUDY SCHEMA
Review list of breast cancer patients at Fred Hutch and University of Washington for potentially eligible 
participants
Eligibility Screening 
Consent patients (n=40)
Complete baseline survey
Play misinformation escape room game intervention and take part in a debrief
Complete post-intervention survey
6.0 STUDY PROCEDURES AND INTERVENTION
6.1 Recruitment strategies
1) Physician support. Prior to initiating recruitment, physicians seeing breast cancer patients at Fred Hutch 
will be introduced to the study and it will be requested that their eligible patients be approached for 
study participation. 
2) EPIC reports. We will use EPIC reports to identify patients who meet eligibility criteria. The reports will 
include the patient’s name, age, gender identity, and next appointment details. Once patients are 
identified, study staff will approach patients in person or contact patients via phone to discuss the study 
and screen for eligibility. 
3) Direct referrals and patient lists from breast cancer clinics. The breast cancer patient lists will be 
queried to identify potential participants and clinicians will also provide direct referrals. Clinicians can 
send study staff the names and MRNs of potential patients and/or provide study staff contact 
information to interested patients. Once patients are identified, study staff will approach patients in 
person or contact patients via phone to discuss the study and screen for eligibility.
4) Support groups. Study staff will communicate about the study through online patient support groups for 
breast cancer patients. Study staff will send e-mail messages to support groups. Potential participants 
will provide the University of Washington team with the following pieces of information: age, breast 
cancer stage, number of months since diagnosis, demographics.
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6.2 Estimated Accrual 
Our goal is to consent 40 study participants total (8 groups of n=5). Based on clinic volume and patient flow, 
we estimate that we can approach and consent n=40 patients within 6 months. On average, in each year of 
2020 and 2021, approximately 1,659 new breast cancer patients were diagnosed and treated at Fred Hutch 
(formerly SCCA), with 1,492 being stage 0-III breast cancer patients. Thus, our proposed recruitment goal is 
achievable. If a patient drops out prior to the intervention, they will be replaced to reach a final n of =40. 
6.3 Consent and Data Collection
If a participant is interested and eligible, study staff will confirm email address and cell phone number. 
Participants will determine mode of sending communication, either via phone or email. 
Table 1 provides information on data collected in this study survey. Please note that some measures map 
directly on to Study Aims 1 and 2 and other variables are exploratory in nature, as we anticipate the game to 
influence these variables as well.
Table 1. Survey measures to be collected
Informed Consent 
Prior to any data collection, participants will provide written (in person) or electronic informed consent via a 
HIPPA-compliant and secured REDCap electronic form (eConsenting) for participation in the study and data 
collection procedures, including release of medical records regarding cancer diagnosis and cancer treatment. 
Research staff will review the study in detail and outline participant involvement during the screening process 
in person or remotely (via telephone or video conferencing). Research staff will discuss the consent process 
with the potential participant prior to providing consent. All items in the informed consent will be discussed, 
including why the study is being conducted, the number of people participating, what is involved in the study, 
how long the participant will be in the study, the risks and benefits of the study, alternatives to participation, 
Screening
Baseline
Post -completion 
of intervention
(+ 1 week)
Demographics & clinical characteristics
X
X
Disease status and treatment 
X
X
Behaviors done based on information consumed online 
(a 6-item background checklist such as “taken over-the-
counter medicine)
X
Aim 1
     Feasibility
X
     Acceptability
X
     Usability
X
Aim 2
     Types of online information (as measured by 6-item 
checklist about sources of nutrition information 
utilized)
X
     Concern about misinformation and confidence in 
identifying misinformation
X
     Cancer nutrition misinformation beliefs (as measured 
by cancer nutrition beliefs)
X
X
Additional exploratory variables
     Trust and information-seeking
X
X
     Vulnerability to misinformation
X
X
     Healthy skepticism
X
X
     Confidence in and motivation to share information 
with a medical professional
X
X
     Awareness of misinformation
X
X
Exit/debrief questions and interview
Game enjoyment/recommendation to others
X
Qualitative exit interview
X
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confidentiality, rights as a participant, and who to call with questions or concerns. Participants will be 
encouraged to contact research staff any time they have concerns or questions about the study. Each consent 
is implemented in person or in REDCap. Once an individual agrees to participate and consent electronically, 
they will electronically sign the informed consent, then hit submit, and a PDF of the completed consent can be 
automatically generated and saved to preserve the exact consent text along with the research participant’s 
responses. To make this less burdensome, we will collect patients’ doctor/medical institution information as 
part of the medical release form and our staff can directly contact their doctors to confirm agreement and 
appropriateness of their participation in the study. This approach will not apply to caregivers or providers 
involved in this study.
Data Collection 
Eligible participants will undergo in person or remote assessments that will include in person, over the phone, 
video conferencing, and/or web-based data collection. 
Data collection will include completion of a written or electronic eConsent form via a secure HIPPA-compliant 
REDCap survey and the following assessments: (1) Questionnaires assessing demographics, medical history, 
clinical characteristics (pre- and  post-intervention); (2) Feasibility will be assessed by rates of accrual to the 
study; (3) Acceptability will be assessed using two Liker-type scales to assess satisfaction (1 = not at all 
satisfied, 10 = very satisfied) and likelihood to recommend the game to someone else (1 = not at all likely, 5 = 
very likely) (post-intervention); (4) Usability will be assessed with the System Usability Scale (SUS) (post-
intervention only), which is a 10-item scale, scored on a 5-point Likert scale (1 = strongly disagree, 5 = strongly 
agree) (post-intervention); (5) sources of nutrition information utilized (6-item checklist) (baseline), (6) 
behaviors done based on information consumed online (6-item checklist) (baseline); (7) trust and information-
seeking (5-item scale scored on a 7-point Likert scale; 1 = strongly disagree, 7 = strongly agree) (baseline and 
post-intervention); (8) vulnerability to misinformation (3-item scale scored on a 7-point Likert scale; 1 = strongly 
disagree, 7 = strongly agree) (baseline and post-intervention); (9) healthy skepticism (6-item scale scored on a 
7-point Likert scale; 1 = strongly disagree, 7 = strongly agree) (baseline and post-intervention); (10) confidence 
in sharing and motivation to share information with a medical professional (2 items from the “Confidence 
Sharing Information with a Medical Professional” scale scored on a 7-point Likert scale; 1 = not at all confident; 
7 = very confident and 2 adapted items to measure degree of motivation; 1 = not at all motivated, 7 = very 
motivated) (baseline and post-intervention); (11) Awareness of misinformation (baseline and post-intervention), 
(12) Concern about misinformation and confidence in identifying misinformation (baseline and post-
intervention), (13) Cancer nutrition information beliefs (baseline and post-intervention), and (14) brief semi-
structured feedback exit interview (post-intervention only). 
7.0 PARTICIPANT EVALUATION
7.1 Study Questionnaires and Assessments

Background information
o
Demographic and disease characteristics will include age, gender, race/ethnicity, education 
level, marital and parental status, income, cancer type, date of diagnosis, and cancer stage. 
o
Behaviors done based on information consumed online will be assessed with a 6-item checklist 
asking which behaviors participants have done because of something they saw on the Internet 
(e.g., “Taken an over-the-counter medicine or supplements, for example, vitamins, minerals, or 
nutritional supplements").

Aim 1:
o
Feasibility will be assessed by rates of accrual and completion of game sessions. 
o
Acceptability will be assessed using two Likert-type scales to assess satisfaction (1 = not at all 
satisfied, 10 = very satisfied) and likelihood to recommend the game to someone else (1 = not 
at all likely, 5 = very likely).
o
Usability will be assessed using the System Usability Scale (SUS).8,9 The SUS is a reliable, 10-
item measure 10-item scale, scored on a 5-point Likert scale (1=strongly disagree; 5=strongly 
agree), with previously reported excellent internal reliability (Cronbach’s α = 0.91). 

Aim 2:
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o
Types of online information (e.g., sources of nutrition information utilized) will be assessed using 
a 6-item checklist that asks which resources participants or their family members have used to 
find nutrition information in the past 3 months (i.e., a self-care/health and wellness book, a 
telephone advice service, a booklet/flyer shared by a health professional, Internet forums, 
Internet search, social media).
o
Concern about misinformation and confidence in identifying misinformation will be measured 
using our 4-item scale in which patients indicate degree to which they agree with statements 
(e.g., “I feel more confident in my ability to identify misinformation”; 1= strongly disagree, 5 = 
strongly agree).
o
Cancer nutrition information beliefs will be measured using a 15-item checklist of common 
cancer nutrition misinformation and credible nutrition advice. Participants rate the items on a 5-
point Likert-scale (1= definitely false, 5 = definitely true).

Exploratory outcomes:
o
Trust and information-seeking will be assessed using a validated 5-item measure asking the 
degree to which individuals trust health information sources (e.g., “I trust the health information I 
get from my doctor).10 This scale is rated on a 7-point Likert scale indicating the degree to which 
individuals agree with each statement (1 = strongly disagree, 7 = strongly agree).
o
Vulnerability to misinformation will be assessed using a validated 3-item measure that asks 
participants the degree to which they believe they or those in their social network are vulnerable 
to misinformation (e.g., “I am able to identify news or information that misrepresent reality or is 
even false.”11 Items are rated on a 7-point Likert scale (1 = strongly disagree, 7 = strongly 
agree).
o
Healthy skepticism will be assessed using an adapted version of a validated 6-item measure 
that measures the degree to which participants are skeptical of online posts (e.g., “I am 
confident in my assessment of this post as emotionally manipulative/overgeneralizes/doesn’t 
refer to authoritative evidence/cherry picks data").12 Items are rated on a 7-point Likert scale (1 
= strongly disagree, 7 = strongly agree).
o
Confidence in sharing information with a medical professional will be assessed using three 
adapted items from the validated “Confidence Sharing Information with a Medical Professional” 
scale.13 Items ask participants the degree to which they are confident or motivated in sharing 
information with their doctor (e.g., “How confident are you in your ability to ask a doctor for more 
information if you don’t understand what he or she said?”). Items are rated on a 7-point Likert 
scale (1 = not at all confident, 7 = very confident). 
o
Awareness of misinformation will be measured using our 5-item scale used in our prior study to 
assess the degree to which the intervention makes users more aware of misinformation types 
and common tactics (e.g., emotionally charged language, false data; 1 = not at all aware, 7 = 
fully aware).

Exit/debrief questions and interview:
o
Game enjoyment/recommendation to others will be measured using an adapted version of a 12-
item scale designed to assess how much individuals enjoyed the game and would recommend it 
to others (e.g., “I felt content”).14 Items are rated on a 5-point Likert scale (0 = not at all, 4 = 
extremely).
o
Using a semi-structured feedback debrief interview, participants will be asked about their 
experiences with the games to inform future iterations and refinement of the escape room 
game.
7.2 Semi-structured Qualitative Interview
A brief semi-structured feedback interview will be conducted to gain additional insights and feedback for 
modifications needed to the intervention to optimize it. Immediately after the escape room session, a nutrition 
expert will facilitate a 15-20 minute group interview with the participants to give them an opportunity to reflect 
on their experience with the game. The objective of the semi-structured group interview is to understand how 
participants’ attitudes and feelings about misinformation may have been impacted by the escape room 
experience. The interview will also explore how vulnerable participants feel to health information and their 
comfort level with questioning the source and nature of information. The nutrition expert will use a short 
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interview guide (9 questions) to facilitate the group interview. The role of the facilitator will be to elicit people’s 
opinions and allow others to carry the conversation, making sure the discussion stays on topic and stepping in 
to provide additional information as a nutritional expert. 
8.0 PARTICIPANT WITHDRAWAL
Participants can discontinue participating at any time and for any reason, including during a study interview. 
9.0 CONCOMITANT MEDICATIONS
N/A
10.0 ADVERSE EVENTS
10.1 Adverse Event 
This is a low-risk, behavioral intervention study. Any adverse events will be recorded in the Adverse Event 
Summary Form and reported as follows.
10.2 Adverse Event Grading Scale  
0 = No Adverse Event or within normal limits.
1 = Mild Severity: Transient laboratory test alterations; discomforts noted but no disruption of daily 
activities; no therapy, or only symptomatic therapy required.
2 = Moderate Severity: Laboratory test alterations indicating injury without long-term risk; discomfort 
sufficient to modify normal daily activity; specific therapy required (i.e., more than symptomatic).
3 = Serious Severity: Laboratory test indicating a serious health threat or permanent injury; incapacity, 
inability to work, inability to perform normal daily activity; hospitalization required or prolonged; emergency 
treatment required; life-threatening events; death.
Plan for unanticipated AE reporting: All unanticipated AEs related to the study procedures that are severe or 
serious will be reported by Dr. Megan Shen to the IRB within 10 days of notification of the investigator. 
Plan for anticipated AE reporting: All anticipated AEs related to the study procedures will be documented in 
the study’s Reportable Events Log.
Plan for ongoing review of results: The PI will be notified within 24 hours by the research manager of any 
early terminations due to an adverse event. 
Plan for safety review: The PI will perform a cumulative review of all adverse events and premature 
terminations review every 3 months after study initiation or after completion of 50% of participant visits, 
whichever occurs first. 
Plan for annual reporting: A summary of the investigation including all adverse events and how they were 
handled, enrollment, drop-outs and reason for discontinuation and any protocol modifications will be provided 
to the IRB on an annual basis. 
Annual Reports will contain: 
a.
The number of adverse events and an explanation of how each event was handled. 
b.
The number of complaints and how each complaint was handled. 
c.
The number of participant withdrawals and an explanation of why the participant withdrew or was 
withdrawn. 
d.
The number of protocol deviations and how each was handled. 
The occurrence of any serious and unexpected event may prompt changes in study protocol. Any such change 
will be approved by the IRB before implementation.  
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10.3 Serious Adverse Event (SAE)
An adverse event should be classified as an SAE if it meets one of the following criteria:
Fatal
Adverse event results in death.
Life threatening: 
The adverse events placed the participant at immediate risk of death. 
This classification did not apply to an adverse event that hypothetically 
might cause death if it were more severe. 
Hospitalization: 
It required or prolonged inpatient hospitalization. Hospitalizations for 
elective medical or surgical procedures or treatments planned before 
enrollment in the treatment plan or routine check-ups are not SAEs by 
this criterion. Admission to a palliative unit or hospice care facility is not 
considered to be a hospitalization. 
Disabling/incapacitating 
Resulted in a substantial and permanent disruption of the participant’s 
ability to carry out normal life functions. 
Congenital anomaly or 
birth defect: 
An adverse outcome in a child or fetus of a participant exposed to the 
molecule or treatment plan regimen before conception or during 
pregnancy. 
Medically significant: 
The adverse event did not meet any of the above criteria but could 
have jeopardized the participant and might have required medical or 
surgical intervention to prevent one of the outcomes listed above. 
11.0 DATA AND SAFETY MONITORING PLAN
This is a low-risk, behavioral intervention study. To ensure data safety and accuracy, the measures described 
below will be taken.
Table 2 below describes each data monitoring activity, responsible staff person, and frequency of review. 
Tracking forms will be developed to document the occurrence of all reviews. The PI will review all reports as 
they are generated. Study data will be stored on a secure network and the file will be password protected. A 
file linking participants’ names and study ID numbers will be stored separately from the data file. This file will 
also be stored on a secure network and password protected. Only study staff will have access to these files 
and the passwords will be changed in the event of study staff turnover. 
Table 2. Data monitoring
Activity
Report
Timing of review by PI
Study Recruitment
Weekly report generated by CRC
Weekly PI review
Enrollment
Weekly report generated by CRC
Weekly PI review
Study Retention
Weekly report generated by CRC
Weekly PI review
Informed Consent
Quality control of each new 
consent
PI reviews all consents upon receipt
Interviews/Self-Report Measures
PI and other study staff will 
review all interview and self-
report materials and complete 
fidelity checklist
PI will review data weekly for 
completeness and accurate entry into a 
spreadsheet for analysis
A data safety and monitoring committee is not needed as this is not a Phase 3 clinical trial. Dr. Megan Shen 
(PI) will oversee the data safety and monitoring for this project. She will meet with the study staff to discuss 
protocols and procedures to ensure participant safety and the validity and integrity of the study data. All staff 
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members will attend trainings on these procedures and will be given information on the importance of reporting 
any adverse event immediately. Dr. Shen and the IRB will be alerted about any adverse events immediately. 
Dr. Shen will discuss any adverse effects and examine available data to assess whether safety is 
compromised. Action to resolve the adverse event will be discussed with IRB prior to implementation. The 
team will enact any actions recommended by the IRB.
12.0 DATA MANAGEMENT/CONFIDENTIALITY
REDCap
We will use REDCap to track, collect and maintain study data. REDCap is a web-based electronic data capture 
system. Using the HIPAA-compliant REDCap platform, we will design, build, and maintain the data forms that 
will be used for data capture, including screening, consenting, participant questionnaires, and staff forms for 
participant tracking. 
13.0 STATISTICAL CONSIDERATIONS
13.1 Study Design
The current study is an open, single-arm trial.
13.2  Analyses
Feasibility, acceptability, and usability will be examined by conducting frequency and descriptive statistics for 
Likert-scale questions and SUS scale. We will conduct preliminary pre/post analyses using repeated 
measures analysis of variance (ANOVAs) on the misinformation belief scales to assess changes in these 
beliefs. Finally, we will conduct qualitative analyses on the open-ended questions using a responsive 
interviewing model for data coding and analysis in which data units or “blocks of information that are 
examined together” (p. 202) are combined based on the theme they represent.15 Trained raters will 
independently review the transcripts and identify passages that include information on participants’ 
suggestions for modifications to the escape room game. The themes identified in this analysis will inform 
additional revisions to the intervention as determined by the study investigators. 
13.4 Ethnic and Gender Distribution Chart
We will recruit cancer patients who are treated at Fred Hutchinson Cancer Center, which reflect the 
demographics for the Seattle area and the previously SCCA population. Based on the demographics of the 
entire SCCA oncology patient population since 2001 (for which data is currently available), 78.6% of cancer 
patients are female. Patient race/ethnicity distribution in this population are 53.2% White, 10% Asian, 6.8% 
Black or African Americans, 1.3% Alaskan Indian or Alaskan Native, 1.2% Hispanic, 1.1% other, 0.8% Native 
Hawaiian or Other Pacific Islander, 0.3% multiracial, and 25.3% unknown. The projected target patient accrual 
for this study is based on these estimates. Due to this recruiting a breast cancer patient population, we 
anticipate recruiting female only patients.
Projected Target Accrual
ETHNIC AND GENDER DISTRIBUTION CHART
TARGETED / PLANNED ENROLLMENT: Number of Subjects
Sex / Gender
Ethnic Category
Females
Males
Total
Hispanic or Latino
1
0
1
Not Hispanic or Latino
39
0
39
Ethnic Category Total of All Subjects*
40
0
40
Racial Categories
American Indian / Alaska Native
1
0
1
Asian
4
0
4
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Native Hawaiian or Other Pacific Islander
1
0
1
Black or African American
2
0
2
White
32
0
32
More Than One Race
0
0
0
Unknown
0
0
0
Racial Categories: Total of All Subjects*
40
0
40
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14.0 INVESTIGATOR OBLIGATIONS
The PI is responsible for the conduct of the study at the site and is responsible for personally overseeing the 
treatment of all study participants. The PI must assure that all study site personnel, including Co-Investigators 
and other study staff members, adhere to the study protocol and to all applicable regulations and guidelines 
regarding proper research protocols both during and after study completion. All participants are informed of the 
nature of the study, its possible risks, and their right to withdraw at any time, and each participant signs a form 
indicating their consent to participate prior to engaging in any study-related procedures. 
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Swire-Thompson B, Lazer D. Public Health and Online Misinformation: Challenges and 
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3.
Warner EL, Waters AR, Cloyes KG, Ellington L, Kirchhoff AC. Young adult cancer caregivers' exposure 
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Grimes DR. The Struggle against Cancer Misinformation. Cancer Discov. 2022;12(1):26-30.
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Warner EL, Basen-Engquist KM, Badger TA, Crane TE, Raber-Ramsey M. The Online Cancer Nutrition 
Misinformation: A framework of behavior change based on exposure to cancer nutrition misinformation. 
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Moderate and Severe Fatigue Among Head and Neck Cancer Patients—Pre-efficacy Study in the 
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Summers S, Watt A. Quick and Dirty Usability Testing in the Technical Communication Classroom. 
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Benotsch EG, Kalichman S, Weinhardt LS. HIV-AIDS patients' evaluation of health information on the 
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Altay S, Acerbi A. People believe misinformation is a threat because they assume others are gullible. 
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Roozenbeek J, Van Der Linden S, Goldberg B, Rathje S, Lewandowsky S. Psychological inoculation 
improves resilience against misinformation on social media. Science Advances. 2022;8(34):eabo6254.
13.
Morris NS, Field TS, Wagner JL, et al. The association between health literacy and cancer-related 
attitudes, behaviors, and knowledge. Journal of health communication. 2013;18(sup1):223-241.
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IJsselsteijn W, Van Den Hoogen W, Klimmt C, et al. Measuring the experience of digital game 
enjoyment. Paper presented at: Proceedings of measuring behavior2008.
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Rubin HJ, Rubin I. Qualitative interviewing: The art of hearing data. 2005. In: Sage Publications, Inc; 
2005.
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