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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2023-08424 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| 20282 | Other Identifier | Fred Hutch/University of Washington Cancer Consortium | |
| P30CA015704 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Supportive Care (escape room game) | Experimental | Patients play the virtual misinformation escape room game consisting of 5 puzzles and a final task over 30-45 minutes on study. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Educational Intervention | Other | Play virtual misinformation escape room game |
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| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Accrued to the Study (Feasibility) | The percentage of patients who accrue to the study among those who are eligible and approached. | At enrollment |
| Percentage of Patients Who Complete Game Sessions (Feasibility) | The percentage of patients who complete the game. | Up to 1 week |
| Satisfaction (Acceptability) | Will be assessed using a Likert-type question to assess satisfaction with the game (1 = not at all satisfied, 10 = very satisfied) | Up to 1 week |
| 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). | Up to 1 week |
| 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. | Up to 1 week |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
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Inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Megan Shen | Fred Hutch/University of Washington Cancer Consortium | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fred Hutch/University of Washington Cancer Consortium | Seattle | Washington | 98109 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Escape Room Game | Patients play the virtual misinformation escape room game consisting of 5 puzzles and a post-game debrief 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 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 7, 2024 |
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| Interview | Other | Ancillary studies |
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| Survey Administration | Other | Ancillary studies |
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| Telemedicine | Other | Play virtual misinformation escape room game |
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| At baseline |
| 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). | Up to 1 week |
| 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). | At baseline and up to 1 week |
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| NOT COMPLETED |
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Total number of participants enrolled who completed baseline.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Of the n=43 patients who entered baseline data, n=2 entered the date of the survey in the date of birth field, causing missing data on this variable. | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Count of Participants | Participants | At enrollment |
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| Primary | Percentage of Patients Who Complete Game Sessions (Feasibility) | The percentage of patients who complete the game. | Posted | Count of Participants | Participants | Up to 1 week |
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| 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) | Posted | Mean | Standard Deviation | units on a scale | Up to 1 week |
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| 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). | Posted | Mean | Standard Deviation | units on a scale | Up to 1 week |
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| 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. | Posted | Mean | Standard Deviation | score on a scale | Up to 1 week |
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| 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). | Posted | Count of Participants | Participants | At baseline |
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| 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). | Posted | Mean | Standard Deviation | units on a scale | Up to 1 week |
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| 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). | Posted | Mean | Standard Deviation | score on a scale | At baseline and up to 1 week |
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Each enrolled participant was followed for adverse events at the point of consent until the completion of the final survey, up to 44 days.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 | 0 | 45 | 0 | 45 | 0 | 45 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Megan Shen, Associate Professor | Fred Hutchinson Cancer Center | 206-667-4172 | mshen2@fredhutch.org |
| Nov 14, 2024 |
| Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Mar 5, 2024 | Jul 17, 2024 | ICF_000.pdf |
| ID | Term |
|---|---|
| D018479 | Early Intervention, Educational |
| D007407 | Interviews as Topic |
| D017216 | Telemedicine |
| ID | Term |
|---|---|
| D002662 | Child Health Services |
| D003153 | Community Health Services |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
| D011314 | Preventive Health Services |
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
| D003695 | Delivery of Health Care |
| D010346 | Patient Care Management |
| D006298 | Health Services Administration |
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| Unknown or Not Reported |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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