Recruiting

Observational Study

Sponsor:

Washington University School of Medicine

Code:

NCT06910670

Conditions

Cholangiocarcinoma

Colorectal Cancer

Multiple Myeloma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Standard developed materials

Genetics Advisor Decision Aid

Study Details

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).

Conditions

Cholangiocarcinoma

Colorectal Cancer

Multiple Myeloma

Study ID

NCT06910670

Start date

Apr 3, 2025

Status verified date

Jul, 2026

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

240 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Health Services Research

Interventions and Outcome Measures

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.

Interventions

Standard developed materials

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

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.

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 and Locations

Central contacts

Erin Linnenbringer, Ph.D., MS

314-747-1966elinnen@wustl.edu

Bettina Drake, Ph.D., MPH

314-747-4534drakeb@wustl.edu

Locations

Washington University School of Medicine

Recruiting

St Louis, Missouri, United States, 63110

Contacts

Erin Linnenbringer, Ph.D., MS

314-747-1966elinnen@wustl.edu

Principal Investigator:

Erin Linnenbringer, Ph.D., MS

More Information

Sponsor

Washington University School of Medicine

Last update posted

Jul 23, 2026

Last verified

Jul, 2026

Keywords

  • Genetic testing
  • Decision aid
  • Participant engagement

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Washington University School of Medicine on 2026-07-23.