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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06193070
Other study ID # RG1123830
Secondary ID NCI-2023-0842420
Status Recruiting
Phase N/A
First received
Last updated
Start date March 7, 2024
Est. completion date August 31, 2024

Study information

Verified date February 2024
Source Fred Hutchinson Cancer Center
Contact Megan Shen
Phone 206-667-4172
Email mshen2@fredhutch.org
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


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).


Recruitment information / eligibility

Status Recruiting
Enrollment 40
Est. completion date August 31, 2024
Est. primary completion date August 31, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms

  • Anatomic Stage I Breast Cancer AJCC v8
  • Anatomic Stage II Breast Cancer AJCC v8
  • Anatomic Stage III Breast Cancer AJCC v8
  • Breast Neoplasms

Intervention

Other:
Educational Intervention
Play virtual misinformation escape room game
Interview
Ancillary studies
Survey Administration
Ancillary studies
Telemedicine
Play virtual misinformation escape room game

Locations

Country Name City State
United States Fred Hutch/University of Washington Cancer Consortium Seattle Washington

Sponsors (2)

Lead Sponsor Collaborator
Fred Hutchinson Cancer Center National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. At baseline
Primary Rates of accrual to the study (Feasibility) The percentage of patients who accrue to the study among those who are eligible and approached. At enrollment
Primary Rates of completion of game sessions (feasibility) The percentage of patients who complete the game. Up to 1 week
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) Up to 1 week
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). Up to 1 week
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 a = 0.91). Up to 1 week
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. At baseline
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). Up to 1 week
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). At baseline and up to 1 week
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