Implementing a Randomized Control Trial to Test the Expanded Web-based Decision Aid
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Enrollment
- 197
- Locations
- 1
- Primary Endpoint
- Change in self-efficacy about genomic test results
Study Overview
Brief Summary
The overall goal of the randomized control trial (RCT) will be to evaluate the efficacy of modifications to a web-based tool for patient decision-making regarding return of genomic results that will more closely focus on rare cancers. Participants will be given access to a web-based decision aid (or a standard control) that guides participants in making decisions about what type of genomic results they would like to receive from testing performed in the PE-CGS study (NCT06340646).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Health Services Research
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Eligibility Criteria:
- •Enrolled in the WU-PE-CGS study (IRB#202106129); that eligibility entails:
- •Diagnosis of cholangiocarcinoma
- •Diagnosis of multiple myeloma, must be African American
- •Diagnosis of colorectal cancer, must be African American and age 65 or older at time of diagnosis
- •At least 18 years old.
- •Able to understand an IRB-approved informed consent document and agree to participation
- •Have access to a personal computer, tablet or mobile device
Exclusion Criteria
- Not provided
Arms & Interventions
Intervention: Genetics Advisor Online Tool
The Intervention group will receive the expanded Genetics Advisor decision aid.
Intervention: Genetics Advisor Decision Aid (Other)
Control: Standard developed materials
The control group will receive a description of each type of genomic sequencing result they could receive using the standard informed consent process for the return-of-results protocol.
Outcomes
Primary Outcomes
Change in self-efficacy about genomic test results
Time Frame: Baseline, after viewing assigned materials (day 1), and 3-months after enrollment
7-item, Likert scale. This scale has 5 points ranging from strongly disagree to strongly agree. 1= Strongly disagree, 2= Disagree, 3= Neither Agree nor Disagree, 4= Agree, 5= Strongly Agree. All items are scored such that 'strongly agree' reflects a correct response and 'agree' reflects a less confident correct response in the correct direction. This will be scored by adding up the numbers for each of the 7 items regarding self-efficacy. The total score ranges from 7 to 35. A higher score for the participant represents higher participant self-efficacy.
Secondary Outcomes
- Decisional conflict scores categorized by genomic sequencing testing attitudes(After viewing assigned materials (day 1) and 3-months after enrollment)
- Change in decisional conflict(After viewing assigned materials (day 1) and 3-months after enrollment)
- Change in knowledge of clinical genetic testing(After viewing assigned materials (day 1) and 3-months after enrollment)
- Change in expectations for potential benefits of cancer genomic sequencing(After viewing assigned materials (day 1) and 3-months after enrollment)
- Decisional conflict scores categorized by demographic factors(After viewing assigned materials (day 1) and 3-months after enrollment)
- Knowledge scores categorized by demographic factors(After viewing assigned materials (day 1) and 3-months after enrollment)
- Decisional conflict scores categorized by genomic literacy(After viewing assigned materials (day 1) and 3-months after enrollment)
- Knowledge scores categorized by genomic literacy(After viewing assigned materials (day 1) and 3-months after enrollment)
- Knowledge scores categorized by genomic sequencing testing attitudes(After viewing assigned materials (day 1) and 3-months after enrollment)
- Decisional conflict scores categorized by clinical characteristics(After viewing assigned materials (day 1) and 3-months after enrollment)
- Knowledge scores categorized by clinical characteristics(After viewing assigned materials (day 1) and 3-months after enrollment)