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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

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

ArmDescriptionAssigned 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
  • 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.

Recruiting Locations

Washington University in St. Louis and nearby locations

Washington University School of Medicine
St Louis 4407066, Missouri 4398678 63110
Contact:
Graham Colditz, M.D., DrPH, MPH
314-454-7939
colditzg@wustl.edu

More Details

NCT ID
NCT06340646
Status
Recruiting
Sponsor
Washington University School of Medicine

Study Contact

Graham Colditz, M.D., DrPH, MPH
314-454-7939
colditzg@wustl.edu

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.