Trial Outcomes & Findings for An Escape Room Intervention to Help Improve Breast Cancer Patients' Ability to Navigate Online Access to Nutrition Information (NCT NCT06193070)

NCT ID: NCT06193070

Last Updated: 2024-12-27

Results Overview

The percentage of patients who accrue to the study among those who are eligible and approached.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

45 participants

Primary outcome timeframe

At enrollment

Results posted on

2024-12-27

Participant Flow

Participant milestones

Participant milestones
Measure
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
Overall Study
STARTED
45
Overall Study
COMPLETED
43
Overall Study
NOT COMPLETED
2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Escape Room Game
n=43 Participants
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
Age, Continuous
52.2 years
STANDARD_DEVIATION 11.55 • n=41 Participants • 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.
Sex: Female, Male
Female
43 Participants
n=43 Participants
Sex: Female, Male
Male
0 Participants
n=43 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
1 Participants
n=43 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
42 Participants
n=43 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
n=43 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=43 Participants
Race (NIH/OMB)
Asian
5 Participants
n=43 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=43 Participants
Race (NIH/OMB)
Black or African American
0 Participants
n=43 Participants
Race (NIH/OMB)
White
34 Participants
n=43 Participants
Race (NIH/OMB)
More than one race
2 Participants
n=43 Participants
Race (NIH/OMB)
Unknown or Not Reported
2 Participants
n=43 Participants
Region of Enrollment
United States
43 participants
n=43 Participants

PRIMARY outcome

Timeframe: At enrollment

The percentage of patients who accrue to the study among those who are eligible and approached.

Outcome measures

Outcome measures
Measure
Escape Room Game
n=45 Participants
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
Percentage of Participants Accrued to the Study (Feasibility)
45 Participants

PRIMARY outcome

Timeframe: Up to 1 week

The percentage of patients who complete the game.

Outcome measures

Outcome measures
Measure
Escape Room Game
n=43 Participants
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
Percentage of Patients Who Complete Game Sessions (Feasibility)
43 Participants

PRIMARY outcome

Timeframe: 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)

Outcome measures

Outcome measures
Measure
Escape Room Game
n=43 Participants
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
Satisfaction (Acceptability)
6.8 units on a scale
Standard Deviation 2.34

PRIMARY outcome

Timeframe: 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).

Outcome measures

Outcome measures
Measure
Escape Room Game
n=43 Participants
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
Likelihood to Recommend the Game to Someone Else (Acceptability)
3.1 units on a scale
Standard Deviation 1.31

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure
Escape Room Game
n=43 Participants
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
Usability (System Usability Scale)
59.3 score on a scale
Standard Deviation 19.70

SECONDARY outcome

Timeframe: 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).

Outcome measures

Outcome measures
Measure
Escape Room Game
n=43 Participants
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
Types of Online Information
Self-care/Health and wellness book
16 Participants
Types of Online Information
Telephone advice service
1 Participants
Types of Online Information
Booklet/flyer shared by a health professional
5 Participants
Types of Online Information
Internet forums
7 Participants
Types of Online Information
Internet search
30 Participants
Types of Online Information
Social media
14 Participants
Types of Online Information
None of the above
6 Participants

SECONDARY outcome

Timeframe: 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).

Outcome measures

Outcome measures
Measure
Escape Room Game
n=43 Participants
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
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
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
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
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 outcome

Timeframe: 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).

Outcome measures

Outcome measures
Measure
Escape Room Game
n=43 Participants
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
Cancer Nutrition Information Beliefs
Pre-game score
3.6 score on a scale
Standard Deviation 0.68
Cancer Nutrition Information Beliefs
Post-game score
3.8 score on a scale
Standard Deviation 0.73

Adverse Events

Escape Room Game

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Megan Shen, Associate Professor

Fred Hutchinson Cancer Center

Phone: 206-667-4172

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place