NCT06193070

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 12, 2023

Completed
24 days until next milestone

First Posted

Study publicly available on registry

January 5, 2024

Completed
2 months until next milestone

Study Start

First participant enrolled

March 7, 2024

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 22, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 22, 2024

Completed
6 months until next milestone

Results Posted

Study results publicly available

December 27, 2024

Completed
Last Updated

December 27, 2024

Status Verified

December 1, 2024

Enrollment Period

4 months

First QC Date

December 12, 2023

Results QC Date

December 3, 2024

Last Update Submit

December 3, 2024

Conditions

Outcome Measures

Primary Outcomes (5)

  • 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

Secondary Outcomes (3)

  • Types of Online Information

    At baseline

  • Concern About Misinformation and Confidence in Identifying Misinformation

    Up to 1 week

  • Cancer Nutrition Information Beliefs

    At baseline and up to 1 week

Study Arms (1)

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.

Other: Educational InterventionOther: InterviewOther: Survey AdministrationOther: Telemedicine

Interventions

Play virtual misinformation escape room game

Also known as: Escape room cancer nutrition game
Supportive Care (escape room game)

Ancillary studies

Supportive Care (escape room game)

Ancillary studies

Supportive Care (escape room game)

Play virtual misinformation escape room game

Also known as: Telehealth
Supportive Care (escape room game)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fred Hutch/University of Washington Cancer Consortium

Seattle, Washington, 98109, United States

Location

MeSH Terms

Interventions

Early Intervention, EducationalInterviews as TopicTelemedicine

Intervention Hierarchy (Ancestors)

Child Health ServicesCommunity Health ServicesHealth ServicesHealth Care Facilities Workforce and ServicesPreventive Health ServicesData CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public HealthDelivery of Health CarePatient Care ManagementHealth Services Administration

Results Point of Contact

Title
Dr. Megan Shen, Associate Professor
Organization
Fred Hutchinson Cancer Center

Study Officials

  • Megan Shen

    Fred Hutch/University of Washington Cancer Consortium

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

December 12, 2023

First Posted

January 5, 2024

Study Start

March 7, 2024

Primary Completion

June 22, 2024

Study Completion

June 22, 2024

Last Updated

December 27, 2024

Results First Posted

December 27, 2024

Record last verified: 2024-12

Data Sharing

IPD Sharing
Will not share

Locations