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Trial Outcomes & Findings for Overcoming Barriers to the Uptake of Cascade Screening for Lynch Syndrome: Workbook Feasibility Study (NCT NCT04978350)

NCT ID: NCT04978350

Last Updated: 2025-07-03

Results Overview

Participants evaluated the workbook using seven acceptability criteria rated on a 5-point Likert scale, where 1 indicated "Strongly Disagree" and 5 indicated "Strongly Agree." The criteria assessed ease of use, clarity of exercises, enjoyment, usefulness for understanding Lynch Syndrome, support for communicating genetic information, time acceptability, and overall satisfaction. Each participant's responses were summed up to produce a total acceptability score ranging from 7 to 35, with higher scores indicating greater acceptability. A score of 28 or higher (80% of the maximum score, which was 35) was defined as an acceptable intervention.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

20 participants

Primary outcome timeframe

Post 4 Weeks of Workbook Use

Results posted on

2025-07-03

Participant Flow

Participants were recruited from 08/01/2021 through 04/02/2024 at one cancer center in North Carolina.

A total of 20 subjects consented and started to the study.

Participant milestones

Participant milestones
Measure
Educational Workbook Arm
Participants will receive an electronic PDF version of an educational workbook via email on cascade screening in families with Lynch Syndrome.
Overall Study
STARTED
20
Overall Study
COMPLETED
14
Overall Study
NOT COMPLETED
6

Reasons for withdrawal

Reasons for withdrawal
Measure
Educational Workbook Arm
Participants will receive an electronic PDF version of an educational workbook via email on cascade screening in families with Lynch Syndrome.
Overall Study
Lost to Follow-up
6

Baseline Characteristics

Overcoming Barriers to the Uptake of Cascade Screening for Lynch Syndrome: Workbook Feasibility Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Educational Workbook Arm
n=20 Participants
Participants will receive an electronic PDF version of an educational workbook via email on cascade screening in families with Lynch Syndrome.
Age, Customized
<18 years old
0 Participants
n=5 Participants
Age, Customized
18-40 years old
5 Participants
n=5 Participants
Age, Customized
41- 64 years old
10 Participants
n=5 Participants
Age, Customized
Unknown
5 Participants
n=5 Participants
Sex/Gender, Customized
Female
14 Participants
n=5 Participants
Sex/Gender, Customized
Male
1 Participants
n=5 Participants
Sex/Gender, Customized
Unknown/Not reported
5 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
1 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
14 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
5 Participants
n=5 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=5 Participants
Race (NIH/OMB)
Asian
0 Participants
n=5 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=5 Participants
Race (NIH/OMB)
Black or African American
1 Participants
n=5 Participants
Race (NIH/OMB)
White
12 Participants
n=5 Participants
Race (NIH/OMB)
More than one race
0 Participants
n=5 Participants
Race (NIH/OMB)
Unknown or Not Reported
7 Participants
n=5 Participants
Region of Enrollment
United States
20 participants
n=5 Participants

PRIMARY outcome

Timeframe: Post 4 Weeks of Workbook Use

Population: Participants who joined the study and responded to the questionnaire.

Participants evaluated the workbook using seven acceptability criteria rated on a 5-point Likert scale, where 1 indicated "Strongly Disagree" and 5 indicated "Strongly Agree." The criteria assessed ease of use, clarity of exercises, enjoyment, usefulness for understanding Lynch Syndrome, support for communicating genetic information, time acceptability, and overall satisfaction. Each participant's responses were summed up to produce a total acceptability score ranging from 7 to 35, with higher scores indicating greater acceptability. A score of 28 or higher (80% of the maximum score, which was 35) was defined as an acceptable intervention.

Outcome measures

Outcome measures
Measure
Educational Workbook Arm
n=13 Participants
Participants will receive an electronic PDF version of an educational workbook via email on cascade screening in families with Lynch Syndrome.
Acceptability of Workbook Assessed Through Likert Score Scale
score is higher the threshold
10 Participants
Acceptability of Workbook Assessed Through Likert Score Scale
score is below the threshold
3 Participants

Adverse Events

Educational Workbook Arm

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

Angelo Navas

UNC Lineberger Comprehensive Cancer Center

Phone: 919-445-1128

Results disclosure agreements

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