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

The Washington University

Status: Enrolling

Conditions: Multiple Myeloma; Cholangiocarcinoma; Colorectal Cancer

Treatments: Other: Standard developed materials; Other: Genetics Advisor Decision Aid

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06910670

U2CCA252981 (U.S. NIH Grant/Contract)

202409214

Details and patient eligibility

About

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).

Enrollment: 240 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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240 participants in 2 patient groups

Intervention: Genetics Advisor Online Tool

Experimental group

Description:

The Intervention group will receive the expanded Genetics Advisor decision aid.

Treatment:

Other: Genetics Advisor Decision Aid

Control: Standard developed materials

Active Comparator group

Description:

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.