Implementing a Randomized Control Trial to Test the Expanded Web-based Decision Aid

Purpose

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).

Conditions

  • Cholangiocarcinoma
  • Colorectal Cancer
  • Multiple Myeloma

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Health Services Research
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Intervention: Genetics Advisor Online Tool 		The Intervention group will receive the expanded Genetics Advisor decision aid.
  • Other: Genetics Advisor Decision Aid
    Participants will be given the option to receive different types of results from genomic sequencing. The participants will be given access to a web-based decision aid that elicits participants' values and preferences for receiving results from cancer genomic sequencing to guide them making a decision about what types of results they would like to receive. Participants will be able to choose to receive: (1) no results, or any combination of (2) biomarker information from cancer cells, (3) inherited mutations related to cancer, and (4) inherited mutations related to other medical issues.
Active Comparator
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.

Recruiting Locations

Washington University in St. Louis and nearby locations

Washington University School of Medicine
St Louis 4407066, Missouri 4398678 63110
Contact:
Erin Linnenbringer, Ph.D., MS
314-747-1966
elinnen@wustl.edu

More Details

NCT ID
NCT06910670
Status
Recruiting
Sponsor
Washington University School of Medicine

Study Contact

Erin Linnenbringer, Ph.D., MS
314-747-1966
elinnen@wustl.edu