Anatomic Stage I Breast Cancer AJCC v8, Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage III Breast Cancer AJCC v8
Conditions
Brief summary
This clinical trial evaluates an educational escape room intervention for improving awareness of and concern about breast cancer misinformation and reducing vulnerability to believing cancer misinformation among patients with stage I-III breast cancer. Misinformation, or communication about health information that is inaccurate or false, can have serious health consequences for those that believe it. The rise of the access to and use of various sources of information on the internet such as websites and social media has caused the spread of misinformation and disinformation to grow rapidly, resulting in negative consequences on health outcomes. Cancer misinformation, in particular, has become an increasingly prevalent issue that poses a real threat to the many cancer patients in the United States. The educational escape room intervention is a game designed to teach participants how to discern whether cancer nutrition information is accurate or may potentially be misinformation. Participants are immersed in the narrative while solving puzzles to learn key themes such as the need to talk to their doctors, looking for scientific studies, as well as avoiding fads and trends, miracle cures, anecdotal evidence, and targeted and clickbait ads.
Detailed description
OUTLINE: Patients complete a baseline before playing the virtual cancer nutrition information escape room game. Patients then play the virtual misinformation escape room game consisting of 5 puzzles and a final task over 30-45 minutes on study. Following the escape room game, patients complete a post-game survey and debrief interview (15 minutes).
Interventions
OTHEREducational Intervention
Play virtual misinformation escape room game
OTHERInterview
Ancillary studies
OTHERSurvey Administration
Ancillary studies
OTHERTelemedicine
Play virtual misinformation escape room game
Sponsors
National Cancer Institute (NCI)
Fred Hutchinson Cancer Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age 18 years of age or older * English speaking * Able to provide informed consent * Have access to a computer (desktop or laptop) * Have been previously diagnosed with breast cancer (Stages I-III) and currently in active treatment for breast cancer
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Usability (System Usability Scale) | Up to 1 week | Usability will be assessed using the System Usability Scale (SUS). 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). Total scores on the SUS range from 0-100, with higher scores indicating greater usability. |
| Percentage of Patients Who Complete Game Sessions (Feasibility) | Up to 1 week | The percentage of patients who complete the game. |
| Satisfaction (Acceptability) | Up to 1 week | Will be assessed using a Likert-type question to assess satisfaction with the game (1 = not at all satisfied, 10 = very satisfied) |
| Likelihood to Recommend the Game to Someone Else (Acceptability) | Up to 1 week | Will be assessed using a Likert-type question to assess likelihood to recommend the game to someone else (1 = not at all likely, 5 = very likely). |
| Percentage of Participants Accrued to the Study (Feasibility) | At enrollment | The percentage of patients who accrue to the study among those who are eligible and approached. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Concern About Misinformation and Confidence in Identifying Misinformation | Up to 1 week | Will be assessed using our 4-item scale in which patients indicate degree to which they agree with statements using a 5-point Likert scale (1=strongly disagree, 5=strongly agree). Items asked participants to rate the degree to which they agree with the following: (1) I am more worried about accidentally believing misinformation, (2) I am more worried about accidentally sharing misinformation online, (3) I am more concerned about misinformation in society, and (4) I feel more confident in my ability to identify misinformation). |
| Cancer Nutrition Information Beliefs | At baseline and up to 1 week | Will be assessed using a 15-item checklist of common cancer nutrition misinformation and credible nutrition advice, using a 5-point Likert Scale (1=definitely false, 5 = definitely true). Data reported as an average score at both pre-intervention (pre-game score) and post-intervention (post-game score). |
| Types of Online Information | At baseline | 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 (self-care/health and wellness book, telephone advice service, booklet/flyer shared by a health professional, internet forums, internet search, social media). Reported as count data of number of participants who endorsed one or more sources (self-care/health and wellness book, telephone advice service, booklet/flyer shared by a health professional, internet forums, internet search, social media). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Escape Room Game Patients play the virtual misinformation escape room game consisting of 5 puzzles and a final task over 30-45 minutes on study.
Educational Intervention: Play virtual misinformation escape room game
Interview: Ancillary studies
Survey Administration: Ancillary studies
Telemedicine: Play virtual misinformation escape room game | 43 |
| Total | 43 |
Baseline characteristics
| Characteristic | Escape Room Game |
|---|---|
| Age, Continuous | 52.2 years STANDARD_DEVIATION 11.55 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 42 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 5 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 2 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants |
| Race (NIH/OMB) White | 34 Participants |
| Region of Enrollment United States | 43 participants |
| Sex: Female, Male Female | 43 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 45 |
| other Total, other adverse events | 0 / 45 |
| serious Total, serious adverse events | 0 / 45 |
Outcome results
Primary
Likelihood to Recommend the Game to Someone Else (Acceptability)
Will be assessed using a Likert-type question to assess likelihood to recommend the game to someone else (1 = not at all likely, 5 = very likely).
Time frame: Up to 1 week
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Escape Room Game | Likelihood to Recommend the Game to Someone Else (Acceptability) | 3.1 units on a scale | Standard Deviation 1.31 |
Primary
Percentage of Participants Accrued to the Study (Feasibility)
The percentage of patients who accrue to the study among those who are eligible and approached.
Time frame: At enrollment
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Escape Room Game | Percentage of Participants Accrued to the Study (Feasibility) | 45 Participants |
Primary
Percentage of Patients Who Complete Game Sessions (Feasibility)
The percentage of patients who complete the game.
Time frame: Up to 1 week
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Escape Room Game | Percentage of Patients Who Complete Game Sessions (Feasibility) | 43 Participants |
Primary
Satisfaction (Acceptability)
Will be assessed using a Likert-type question to assess satisfaction with the game (1 = not at all satisfied, 10 = very satisfied)
Time frame: Up to 1 week
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Escape Room Game | Satisfaction (Acceptability) | 6.8 units on a scale | Standard Deviation 2.34 |
Primary
Usability (System Usability Scale)
Usability will be assessed using the System Usability Scale (SUS). 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). Total scores on the SUS range from 0-100, with higher scores indicating greater usability.
Time frame: Up to 1 week
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Escape Room Game | Usability (System Usability Scale) | 59.3 score on a scale | Standard Deviation 19.7 |
Secondary
Cancer Nutrition Information Beliefs
Will be assessed using a 15-item checklist of common cancer nutrition misinformation and credible nutrition advice, using a 5-point Likert Scale (1=definitely false, 5 = definitely true). Data reported as an average score at both pre-intervention (pre-game score) and post-intervention (post-game score).
Time frame: At baseline and up to 1 week
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Escape Room Game | Cancer Nutrition Information Beliefs | Pre-game score | 3.6 score on a scale | Standard Deviation 0.68 |
| Escape Room Game | Cancer Nutrition Information Beliefs | Post-game score | 3.8 score on a scale | Standard Deviation 0.73 |
Comparison: All participants were exposed to the intervention, and pre- and post-game scores within subject were examined.p-value: <0.001t-test, 1 sided
Secondary
Concern About Misinformation and Confidence in Identifying Misinformation
Will be assessed using our 4-item scale in which patients indicate degree to which they agree with statements using a 5-point Likert scale (1=strongly disagree, 5=strongly agree). Items asked participants to rate the degree to which they agree with the following: (1) I am more worried about accidentally believing misinformation, (2) I am more worried about accidentally sharing misinformation online, (3) I am more concerned about misinformation in society, and (4) I feel more confident in my ability to identify misinformation).
Time frame: Up to 1 week
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Escape Room Game | Concern About Misinformation and Confidence in Identifying Misinformation | (1) I am more worried about accidentally believing misinformation. | 2.1 units on a scale | Standard Deviation 1.13 |
| Escape Room Game | Concern About Misinformation and Confidence in Identifying Misinformation | (2) I am more worried about accidentally sharing misinformation online. | 2.0 units on a scale | Standard Deviation 1.18 |
| Escape Room Game | Concern About Misinformation and Confidence in Identifying Misinformation | (3) I am more concerned about misinformation in society. | 3.7 units on a scale | Standard Deviation 1.24 |
| Escape Room Game | Concern About Misinformation and Confidence in Identifying Misinformation | (4) I feel more confident in my ability to identify misinformation. | 3.6 units on a scale | Standard Deviation 0.98 |
Secondary
Types of Online Information
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 (self-care/health and wellness book, telephone advice service, booklet/flyer shared by a health professional, internet forums, internet search, social media). Reported as count data of number of participants who endorsed one or more sources (self-care/health and wellness book, telephone advice service, booklet/flyer shared by a health professional, internet forums, internet search, social media).
Time frame: At baseline
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Escape Room Game | Types of Online Information | Self-care/Health and wellness book | 16 Participants |
| Escape Room Game | Types of Online Information | Telephone advice service | 1 Participants |
| Escape Room Game | Types of Online Information | Booklet/flyer shared by a health professional | 5 Participants |
| Escape Room Game | Types of Online Information | Internet forums | 7 Participants |
| Escape Room Game | Types of Online Information | Internet search | 30 Participants |
| Escape Room Game | Types of Online Information | Social media | 14 Participants |
| Escape Room Game | Types of Online Information | None of the above | 6 Participants |