Washington University Participant Engagement and Cancer Genomic Sequencing Center (WU-PE-CGS)
Purpose
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.
Conditions
- Cholangiocarcinoma
- Multiple Myeloma
- Colon Cancer
- Rectal Cancer
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
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
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Non-Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Health Services Research
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
No Intervention No Return of Genetic Results |
Participants will undergo germline genomic sequencing as part of consenting to the WU-PE-CGS program. Participants will be given the option to receive the results from the genomic sequencing. After they consent to the study, the types of results available to them will be explained by research staff. 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 |
|
|
Experimental Return of Genetic Results |
Participants will undergo germline genomic sequencing as part of consenting to the WU-PE-CGS program. Participants will be given the option to receive the results from the genomic sequencing. After they consent to the study, the types of results available to them will be explained by research staff. 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 |
|
Recruiting Locations
Washington University in St. Louis and nearby locations
St Louis 4407066, Missouri 4398678 63110
More Details
- NCT ID
- NCT06340646
- Status
- Recruiting
- Sponsor
- Washington University School of Medicine