Clinical trial NCT06910670: Implementing a Randomized Control Trial to Test the Expanded Web-based Decision Aid
Official title: Implementing a Randomized Control Trial to Test the Expanded Web-based Decision Aid
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cholangiocarcinoma
Colorectal Cancer
Multiple Myeloma
Keywords: Genetic testing
Decision aid
Participant engagement
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2025-04-04
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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).


Eligibility 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

Primary outcomes:
measure: Change in self-efficacy about genomic test results
timeFrame: Baseline, after viewing assigned materials (day 1), and 3-months after enrollment
Secondary outcomes:
measure: Change in decisional conflict
timeFrame: After viewing assigned materials (day 1) and 3-months after enrollment
measure: Change in knowledge of clinical genetic testing
timeFrame: After viewing assigned materials (day 1) and 3-months after enrollment
measure: Change in expectations for potential benefits of cancer genomic sequencing
timeFrame: After viewing assigned materials (day 1) and 3-months after enrollment
measure: Decisional conflict scores categorized by demographic factors
timeFrame: After viewing assigned materials (day 1) and 3-months after enrollment
measure: Knowledge scores categorized by demographic factors
timeFrame: After viewing assigned materials (day 1) and 3-months after enrollment
measure: Decisional conflict scores categorized by genomic literacy
timeFrame: After viewing assigned materials (day 1) and 3-months after enrollment
measure: Knowledge scores categorized by genomic literacy
timeFrame: After viewing assigned materials (day 1) and 3-months after enrollment
measure: Decisional conflict scores categorized by genomic sequencing testing attitudes
timeFrame: After viewing assigned materials (day 1) and 3-months after enrollment
measure: Knowledge scores categorized by genomic sequencing testing attitudes
timeFrame: After viewing assigned materials (day 1) and 3-months after enrollment
measure: Decisional conflict scores categorized by clinical characteristics
timeFrame: After viewing assigned materials (day 1) and 3-months after enrollment
measure: Knowledge scores categorized by clinical characteristics
timeFrame: After viewing assigned materials (day 1) and 3-months after enrollment
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Erin Linnenbringer, Ph.D., MS
role: PRINCIPAL_INVESTIGATOR
References: