Anatomic Stage I Breast Cancer AJCC v8NCT06193070
An Escape Room Intervention to Help Improve Breast Cancer Patients' Ability to Navigate Online Access to Nutrition Information
A study testing Educational Intervention, Interview and Survey Administration in people with Anatomic Stage I Breast Cancer AJCC v8 and Anatomic Stage II Breast Cancer AJCC v8, run by Fred Hutchinson Cancer Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anatomic Stage I Breast Cancer AJCC v8, Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage III Breast Cancer AJCC v8
- What is being tested?
- Educational Intervention, Interview and Survey Administration
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Mar 2024to 22 Jun 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, 98109
About this study
Official title: Escape Room: A Gamified Approach to Learning About Cancer Nutrition Information
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.
Read the 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).
- Conditions
- Anatomic Stage I Breast Cancer AJCC v8, Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage III Breast Cancer AJCC v8
- Being tested
- Educational Intervention, Interview, Survey Administration, Telemedicine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Educational InterventionOther
Also called Escape room cancer nutrition game
Play virtual misinformation escape room game
InterviewOther
Ancillary studies
Survey AdministrationOther
Ancillary studies
TelemedicineOther
Also called Telehealth
Play virtual misinformation escape room game
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Educational Intervention; Other: Interview; Other: Survey Administration; Other: Telemedicine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants Accrued to the Study (Feasibility)
The percentage of patients who accrue to the study among those who are eligible and approached.
Measured: At enrollment
Percentage of Patients Who Complete Game Sessions (Feasibility)
The percentage of patients who complete the game.
Measured: 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)
Measured: 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).
Measured: 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.
Measured: Up to 1 week
Secondary outcomes (3)
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).
Measured: 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).
Measured: 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).
Measured: At baseline and up to 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2024
- Study start7 Mar 2024
- Primary completion22 Jun 2024
- Study completion22 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Anatomic Stage I Breast Cancer AJCC v8Studies of the same condition, open and under way.
- More trials run by Fred Hutchinson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fred Hutchinson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Megan Shen, Fred Hutchinson Cancer Center
- Investigators
- Megan Shen, Principal investigator, Fred Hutch/University of Washington Cancer Consortium
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06193070
- Sponsor's protocol ID
- RG1123830
- Other IDs
- NCI-2023-08424, 20282, P30CA015704
- Status last verified
- Dec 2024
- First submitted
- 12 Dec 2023
- Last updated
- 27 Dec 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Escape Room: A Gamified Approach to Learning About Cancer Nutrition Information
- ClinicalTrials.gov ID
- NCT06193070
- Acronym / sponsor ID
- RG1123830
- Conditions
- Anatomic Stage I Breast Cancer AJCC v8, Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage III Breast Cancer AJCC v8
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Fred Hutchinson Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 7 Mar 2024 (actual)
- Primary completion
- 22 Jun 2024 (actual)
- Study completion
- 22 Jun 2024 (actual)
- First posted
- 5 Jan 2024 (actual)
- Results
- Posted 27 Dec 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Supportive Care (escape room game) | Experimental | Other: Educational Intervention, Other: Interview, Other: Survey Administration, Other: TelemedicinePatients play the virtual misinformation escape room game consisting of 5 puzzles and a final task over 30-45 minutes on study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Educational InterventionAlso: Escape room cancer nutrition gamePlay virtual misinformation escape room game | Other | Supportive Care (escape room game) |
| InterviewAncillary studies | Other | Supportive Care (escape room game) |
| Survey AdministrationAncillary studies | Other | Supportive Care (escape room game) |
| TelemedicineAlso: TelehealthPlay virtual misinformation escape room game | Other | Supportive Care (escape room game) |
Primary outcome
Percentage of Participants Accrued to the Study (Feasibility)
Time frame: At enrollment
The percentage of patients who accrue to the study among those who are eligible and approached.
Percentage of Patients Who Complete Game Sessions (Feasibility)
Time frame: Up to 1 week
The percentage of patients who complete the game.
Satisfaction (Acceptability)
Time frame: 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)
Time frame: 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).
Usability (System Usability Scale)
Time frame: 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.
3 secondary outcomes
Types of Online Information
Time frame: At baseline
Concern About Misinformation and Confidence in Identifying Misinformation
Time frame: Up to 1 week
Cancer Nutrition Information Beliefs
Time frame: At baseline and up to 1 week
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Megan Shen principal investigator
Fred Hutch/University of Washington Cancer Consortium
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Educational Intervention, Interview and Survey Administration in people with Anatomic Stage I Breast Cancer AJCC v8 and Anatomic Stage II Breast Cancer AJCC v8, run by Fred Hutchinson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 Dec 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants Accrued to the Study (Feasibility) (time frame: At enrollment). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Dec 2024.