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

Part of paid clinical trials in St Louis, Missouri.

Sponsor
Washington University School of Medicine
Study ID
NCT06910670
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Standard developed materials — OTHER
    Participants will be given the option to receive different types of results from genomic sequencing. The choices available to them will be explained by research staff following a script that describes what each type of result means. 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. These choices will be presented to them via a discussion with study staff with accompanying paper information
  • Genetics Advisor Decision Aid — OTHER
    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.

Study Details

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).

Key Dates

Start date
Apr 1, 2025
Status verified
Jul 2025
Primary completion
Dec 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
240 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH

Arms

  • Experimental: Intervention: Genetics Advisor Online Tool
    The Intervention group will receive the expanded Genetics Advisor decision aid.
  • 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.

Primary Outcome Measure

Change in self-efficacy about genomic test results [ Time Frame: Baseline, after viewing assigned materials (day 1), and 3-months after enrollment ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Washington University School of MedicineSt LouisMissouri63110
Erin Linnenbringer, Ph.D., MS
[email protected]
314-747-1966
Erin Linnenbringer, Ph.D., MS (PRINCIPAL_INVESTIGATOR)
Bettina Drake, Ph.D., MPH (SUB_INVESTIGATOR)

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