This clinical trial evaluates the effectiveness of a web-based decision aid for return of genomic results to patients with cholangiocarcinoma, multiple myeloma, or colorectal cancer. Successful implementation of genomic sequencing (a laboratory method that is used to determine the entire genetic makeup of a specific organism or cell type) in diverse patient settings requires adapting health information systems. This includes the development of tools that help patients make informed decisions about their health. A web-based decision aid may be an effective tool for helping patients understand their genetic sequencing results.
Additional locations may be listed on ClinicalTrials.gov for NCT06910670.
Locations matching your search criteria
United States
Missouri
Saint Louis
Siteman Cancer Center at Washington UniversityStatus: Active
Contact: Erin Linnenbringer
Phone: 314-273-2434
PRIMARY OBJECTIVE:
I. Assess the influence of the decision aid on patients' self-efficacy about genomic test results.
SECONDARY OBJECTIVES:
I. To evaluate the impact of the expanded web-based decision aid on decisional conflict among cancer patients undergoing genomic sequencing.
II. Assess the influence of the decision aid on patients' knowledge of clinical genetic testing.
III. Examine patients' expectations for potential benefits of cancer genomic sequencing.
IV. Explore the impact of demographic factors (age, race, socioeconomic status [SES], geographic residence) on decisional conflict and knowledge.
V. Investigate the influence of genomic literacy and attitudes towards genomic testing on decisional conflict and knowledge.
VI. Understand the relationship between clinical characteristics (cancer type, stage at diagnosis, primary treatment) and decisional conflict and knowledge.
EXPLORATORY OBJECTIVES:
I. Assess patients' feelings about genomic testing results and personal utility.
II. Examine patients' choices regarding receiving genetic test results and their achievement of expected benefits.
III. Measure patient-centeredness using the core item set of the Patient Assessment of Cancer Communication Experiences (PACE).
LONG-TERM OBJECTIVE:
I. Use data from the study to inform the modification of the decision aid and participant engagement processes for optimization in years 4-5.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients receive access to the Genetics Advisor online tool which guides patients in making decisions about what type of genomic results they would like to receive on study.
ARM II: Patients receive standard participant engagement materials consisting of a description of each type of genomic sequencing result they could receive on study.
After completion of study intervention, patients are followed up at 3 months.
Trial PhaseNo phase specified
Trial Typehealth services research
Lead OrganizationSiteman Cancer Center at Washington University
Principal InvestigatorErin Linnenbringer