NCT06340646 · Washington University School of Medicine
Washington University Participant Engagement and Cancer Genomic Sequencing Center (WU-PE-CGS)
What this study is about
The overall goal of the WU-PE-CGS is to build a rigorous, scientific evidence base for approaches that direct engagement of cancer patients and post-treatment cancer survivors as participants in cancer research, and to investigate the impact of directly engaging participants in decisions regarding returning of genomic results on participants' health and satisfaction.
View original scientific description
The overall goal of the WU-PE-CGS is to build a rigorous, scientific evidence base for approaches that direct engagement of cancer patients and post-treatment cancer survivors as participants in cancer research, and to investigate the impact of directly engaging participants in decisions regarding returning of genomic results on participants' health and satisfaction. Participants in this study will be presented with the choice of types of genomic results to receive, and the Engagement Optimization Unit (EOU) will investigate the impact of this intervention on participant knowledge, expectations of benefit, personal utility, and decisional conflict.
Interventions
OTHER
Return of Genetic Results: Biomarker information from cancer cells
Participants will receive a novel return of results report that is tailored to their choices.
OTHER
Return of Genetic Results: Inherited mutations related to cancer
Participants will receive a novel return of results report that is tailored to their choices.
OTHER
Return of Genetic Results: Inherited mutations related to other medical issues
Participants will receive a novel return of results report that is tailored to their choices.
Primary outcome measures
Participant knowledge of clinical genetic testing
Time frame: Through completion of follow-up (estimated to be 5 years)
11-item, Likert scale. This scale has 5 points ranging from strongly agree to strongly disagree. 1=Strongly Agree, 2=Agree, 3=Neither Agree nor Disagree, 4=Disagree, 5=Strongly Disagree for items (4, 6-11) are scored such that 'strong disagree' reflects a correct response and 'somewhat disagree' reflects a less confident correct response in the correct direction. Negatively worded items (items 1, 2, 3, and 5) are reverse scored so that 'strongly agree' reflects a correct response and 'somewhat agree' reflect a less confident response in the correct direction. This will be scored by adding up the numbers for each of the 11 items regarding participant knowledge of clinical genetic testing. The total score ranges from 5 to 55. A higher score for the participant represents higher participant knowledge.
Participant expectations of benefit
Time frame: Through completion of follow-up (estimated to be 5 years)
Participants will rate their expectation for 6 potential benefits of cancer genomic sequencing on a 4-point scale ranging from extremely unlikely to extremely likely. . 1=Strongly Agree, 2=Agree, 3=Disagree, 4=Strongly Disagree. This will be scored by adding up the numbers for each of the 8 items regarding participant expectations of benefit. The total score ranges from 6 to 24. A higher score for the participant represents higher levels of expectations.
Participant personal utility
Time frame: Through completion of follow-up (estimated to be 5 years)
Participant personal utility will be measured on a 7-point scale ranging from not at all useful to extremely useful. 1=Not at all useful, 2=A little useful, 3=Somewhat useful, 4=Neutral, 5=Useful, 6=Very useful, 7=Extremely useful. This will be scored by adding up the numbers for each of the 14 items regarding participant personal utility. The total score ranges from 14 to 98. A higher score for the participant represents higher personal utility.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Eligibility Criteria:
- Patients with cholangiocarcinoma, multiple myeloma, or early onset colon or rectal cancer.
- If diagnosed with multiple myeloma, must be African-American.
- If diagnosed with colon or rectal cancer, must be African-American AND must be no older than 65 years old at the time of diagnosis.
- At least 18 years old
- Able to understand and willing to sign an IRB-approved written informed consent document
Where
- St Louis, Missouri
Collaborators
National Cancer Institute (NCI), The Foundation for Barnes-Jewish Hospital
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 11, 2025 · Source of record for eligibility and locations